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Glycoprotein platelet inhibitors


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Glycoprotein platelet inhibitors prevent platelet adhesion by binding to the glycoprotein IIb/IIIa receptors on the plasma membrane of platelets. They stop the actual substrates of the glycoprotein receptors from binding to the receptor, so inhibit platelets from sticking together to form a thrombus, which can lead to stroke, myocardial infarction or deep vein thrombosis.

Glycoprotein platelet inhibitors are used in patients with angina, after a heart attack, angioplasty or other types of coronary vasculature procedures.

See also

Medical conditions associated with glycoprotein platelet inhibitors:

Acute Coronary Syndrome Angina Heart Attack High Risk Percutaneous Transluminal Angioplasty Percutaneous Coronary Intervention Drug List: Aggrastat Integrilin Reopro
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Aplastic Anemia Medications


Definition of Aplastic Anemia: Aplastic anemia occurs when the bone marrow produces too few of all three types of blood cells: red blood cells, white blood cells, and platelets. A reduced number of red blood cells causes hemoglobin to drop. A reduced number of white blood cells makes the patient susceptible to infection. And, a reduced number of platelets causes the blood not to clot as easily.

Drugs associated with Aplastic Anemia

The following drugs and medications are in some way related to, or used in the treatment of Aplastic Anemia. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Aplastic Anemia

Micromedex Care Notes:

Aplastic AnemiaBone Marrow Failure In Children

Medical Encyclopedia:

Anemia

Harvard Health Guide:

Symptoms and treatment for Aplastic Anemia
Drug List:/tags/atgam/
Neupogen
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Promacta


Pronunciation: el-TROM-boe-pag
Generic Name: Eltrombopag
Brand Name: Promacta

Promacta may cause serious and sometimes fatal liver problems. Your doctor will perform blood tests to check your liver before you start Promacta and for as along as you take it. Contact your doctor right away if you experience yellowing of the skin or eyes, dark urine, stomach pain, or unusual tiredness or weakness.


Promacta is used for:

Treating low blood platelets in certain patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP).

Promacta is a thrombopoietin (TPO) receptor agonist. It works by causing the bone marrow to produce more clot-forming cells (platelets).

Do NOT use Promacta if: you are allergic to any ingredient in Promacta you have low blood platelets caused by chemotherapy or by a condition other than chronic ITP (eg, certain bone marrow problems, such as myelodysplastic syndrome or blood cancer; chronic liver disease)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Promacta:

Some medical conditions may interact with Promacta. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of liver or kidney problems, cataracts, other bleeding problems, or bone marrow problems, or if you have had surgery to remove your spleen if you have a blood clot, a history of blood clots, a high number of clot-forming cells (platelets) in the blood, or a condition that may increase your risk of getting a blood clot (eg, antithrombin III deficiency, antiphospholipid syndrome) if you use tobacco products if you take a blood thinner (eg, warfarin) or an antiplatelet medicine (eg, clopidogrel)

Some MEDICINES MAY INTERACT with Promacta. Tell your health care provider if you are taking any other medicines, especially any of the following:

Ciprofloxacin, fluvoxamine, gemfibrozil, omeprazole, rifampin, or trimethoprim because they may increase the risk of Promacta's side effects Acetaminophen, benzylpenicillin, doxorubicin, HMG-CoA reductase inhibitors (eg, atorvastatin, rosuvastatin), meglitinides (eg, nateglinide), methotrexate, narcotic pain medications (eg, codeine), or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of their side effects may be increased by Promacta

This may not be a complete list of all interactions that may occur. Ask your health care provider if Promacta may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Promacta:

Use Promacta as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Promacta comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Promacta refilled. Take Promacta by mouth on an empty stomach at least 1 hour before or 2 hours after a meal. Take Promacta at least 4 hours before or 4 hours after you take certain other medicines (eg, antacids), calcium-rich foods (eg, dairy products, calcium-fortified juices), or supplements that contain iron, calcium, aluminum, magnesium, selenium, or zinc. Do not suddenly stop taking Promacta. You may have an increased risk of severe low platelets and bleeding. If you need to stop Promacta, your doctor will need to monitor your condition. If you miss a dose of Promacta, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Do not take more than 1 dose in 1 day.

Ask your health care provider any questions you may have about how to use Promacta.

Important safety information: If you stop taking Promacta, the number of clot-forming cells (platelets) in your blood may return to a similar low platelet count as before you started taking Promacta. Low blood platelets may increase your risk of bleeding, especially if you are also taking certain other medicines (eg, anticoagulants such as warfarin, antiplatelet medicines such as clopidogrel). These effects are most likely to occur within 4 weeks after you stop taking Promacta. Your doctor will check your blood platelet counts for at least 4 weeks after you stop taking Promacta. Tell your doctor if you have unusual bruising or bleeding after you stop taking Promacta. Avoid activities that may cause bruising or injury. Discuss any questions or concerns with your doctor. Tell your doctor or dentist that you take Promacta before you receive any medical or dental care, emergency care, or surgery. Serious blood clots have occurred in patients taking Promacta. Some serious blood clots may be fatal. The risk of developing a blood clot may be greater if you have a high number of clot-forming cells (platelets) in the blood. However, blood clots have occurred in patients with normal or low blood platelet levels. Tell your doctor immediately if you notice any signs of a blood clot (eg, pain, redness, tenderness, or swelling in the legs; chest pain; shortness of breath; coughing up blood). Lab tests, including liver function, complete blood cell counts, peripheral blood smears, and eye exams, may be performed while you use Promacta and for at least 4 weeks after you stop Promacta. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Promacta with caution in East Asian patients (eg, Chinese, Japanese, Taiwanese, Korean) and in patients who have moderate to severe liver problems. They may be more sensitive to the medicine and may require a lower dose than other patients. Discuss any questions or concerns with your doctor. Use Promacta with caution in the ELDERLY; they may be more sensitive to its effects. Promacta should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: It is not known if Promacta can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Promacta while you are pregnant. It is not known if Promacta is found in breast milk. Do not breast-feed while taking Promacta. Possible side effects of Promacta:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; diarrhea; indigestion; menstrual changes; mild flu-like symptoms (eg, fever, headache, tiredness, sore throat, body aches); minor muscle aches or pain; nausea; runny or stuff nose; sneezing; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding of the eye or eyelid; chest pain; coughing; coughing up blood; dark urine; frequent, painful, or urgent urination; new or worsening vision problems (eg, cloudy vision); pain, redness, tenderness, or swelling in the legs; severe or persistent nausea, vomiting, or stomach pain; symptoms of heart attack (eg, pain in the chest or jaw; numbness or an arm or leg; sudden, severe vomiting or headache; fainting); symptoms of stroke (eg, confusion, slurred speech, sudden vision changes, one-sided weakness); trouble breathing; unusual bruising or bleeding; unusual burning, itching, numbness, or tingling of the skin; unusual tiredness or weakness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Promacta side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bleeding; chest pain; confusion; coughing; dark urine; one-sided weakness; pain, redness, tenderness, or warmth in the legs; slurred speech; trouble breathing; unusual tiredness or weakness; vision problems; yellowing of the skin or eyes.

Proper storage of Promacta:

Store Promacta at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Promacta out of the reach of children and away from pets.

General information: If you have any questions about Promacta, please talk with your doctor, pharmacist, or other health care provider. Promacta is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Promacta. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Promacta resources Promacta Side Effects (in more detail) Promacta Use in Pregnancy & Breastfeeding Promacta Drug Interactions Promacta Support Group 1 Review for Promacta - Add your own review/rating Promacta Prescribing Information (FDA) Promacta Consumer Overview Promacta Monograph (AHFS DI) Promacta Advanced Consumer (Micromedex) - Includes Dosage Information Eltrombopag Professional Patient Advice (Wolters Kluwer) Compare Promacta with other medications Idiopathic Thrombocytopenic Purpura Thrombocytopenia Idiopathic
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Nebcin


Pronunciation: TOE-bra-MYE-sin
Generic Name: Tobramycin
Brand Name: Nebcin

Nebcin has caused kidney problems, nerve damage, or permanent hearing loss, even at usual doses. Hearing loss can occur even after the medicine is stopped. If you already have kidney problems or hearing difficulty, tell your doctor. Notify your doctor right away if any of the following occur: ringing in ears, hearing loss, unusual change in amount of urine, dizziness, numbness, skin tingling, muscle twitching, or seizures. Nebcin may be stopped if you develop kidney or hearing problems. Your doctor will monitor your progress to minimize the possibility of these effects occurring and to run certain tests (eg, hearing and/or kidney tests). Do not use Nebcin with other medicines that can cause nerve, kidney, or hearing problems. Other factors that increase the risk of these side effects occurring include premature and newborn infants, advanced age, or dehydration. Avoid other medicines that may harm the kidneys or decrease hearing (eg, other aminoglycosides [eg, gentamicin], cephaloridine, viomycin, polymyxin B, colistin, cisplatin, vancomycin) while you are using Nebcin. Do not use Nebcin with certain diuretics (eg, furosemide, ethacrynic acid).

Nebcin may cause fetal harm if used during pregnancy.


Nebcin is used for:

Treating serious infections caused by certain bacteria.

Nebcin is an aminoglycoside antibiotic. It works by killing sensitive bacteria.

Do NOT use Nebcin if: you are allergic to any ingredient in Nebcin or another aminoglycoside antibiotic (eg, gentamicin) you are taking certain diuretics (eg, furosemide, ethacrynic acid), cyclosporine, methoxyflurane, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Nebcin:

Some medical conditions may interact with Nebcin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have myasthenia gravis (a condition in which the muscles become progressively paralyzed) or Parkinson disease if you have hearing problems, nerve problems, kidney problems, or severe or extensive burns, or you are dehydrated

Some MEDICINES MAY INTERACT with Nebcin. Tell your health care provider if you are taking any other medicines, especially any of the following:

Cephaloridine, cephalosporins (eg, ceftizoxime), cisplatin, colistin, cyclosporine, fludarabine, loop diuretics (eg, furosemide, ethacrynic acid), methoxyflurane, nitrosoureas (eg, carmustine), NSAIDs (eg, ibuprofen), polymyxin B, vancomycin, or viomycin because they may increase the risk of Nebcin's side effects, including increased risk of kidney or hearing loss Beta-lactam antibiotics (eg, penicillin, imipenem, ceftizoxime) because they may decrease Nebcin's effectiveness Nondepolarizing muscle relaxants (eg, atracurium) or succinylcholine because the risk of their side effects may be increased by Nebcin

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nebcin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Nebcin:

Use Nebcin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Nebcin is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Nebcin at home, a health care provider will teach you how to use it. Be sure you understand how to use Nebcin. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. Do not use Nebcin if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal. If you miss a dose of Nebcin, use it as soon as possible. Check with your doctor or pharmacist for instructions on scheduling other doses.

Ask your health care provider any questions you may have about how to use Nebcin.

Important safety information: Nebcin only works against bacteria; it does not treat viral infections (eg, the common cold). Drinking extra fluids while you are using Nebcin is recommended. Check with your doctor for instructions. Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor. Be sure to use Nebcin for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future. Long-term or repeated use of Nebcin may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this. Some of these products contain sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if your product has sulfites in it. Tell your doctor or dentist that you take Nebcin before you receive any medical or dental care, emergency care, or surgery. Lab tests, including kidney function, hearing tests, blood electrolyte levels, and tobramycin levels, may be performed while you use Nebcin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Nebcin with caution in the ELDERLY; they may be more sensitive to its effects, especially kidney or hearing problems. Nebcin should be used with extreme caution in CHILDREN younger than 10 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: Nebcin has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nebcin while you are pregnant. It is not known if Nebcin is found in breast milk. Do not breast-feed while taking Nebcin. Possible side effects of Nebcin:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; headache; nausea; pain, swelling, or redness at the injection site; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); clumsiness; confusion; decreased hearing or other hearing changes; decreased urination; dizziness or lightheadedness; feeling of a whirling motion; fever, chills, or persistent sore throat; hearing loss; loss of coordination; muscle weakness; numbness or tingling; red, swollen, blistered, or peeling skin; ringing or roaring in the ears; seizures; severe or persistent diarrhea; stomach pain or cramps; unusual bruising or bleeding; vaginal irritation or discharge.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Nebcin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms include decreased urination; dizziness; hearing loss; trouble breathing.

Proper storage of Nebcin:

Nebcin is usually handled and stored by a health care provider. If you are using Nebcin at home, store Nebcin as directed by your pharmacist or health care provider. Keep Nebcin, as well as syringes and needles, out of the reach of children and away from pets.

General information: If you have any questions about Nebcin, please talk with your doctor, pharmacist, or other health care provider. Nebcin is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Nebcin. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Nebcin resources Nebcin Side Effects (in more detail) Nebcin Use in Pregnancy & Breastfeeding Nebcin Drug Interactions Nebcin Support Group 0 Reviews for Nebcin - Add your own review/rating Nebcin Advanced Consumer (Micromedex) - Includes Dosage Information Nebcin injection Concise Consumer Information (Cerner Multum) Tobramycin Prescribing Information (FDA) Tobramycin eent Monograph (AHFS DI) Tobramycin Professional Patient Advice (Wolters Kluwer) Tobi Prescribing Information (FDA) Tobi inhalation Concise Consumer Information (Cerner Multum) Tobi Advanced Consumer (Micromedex) - Includes Dosage Information Tobi Monograph (AHFS DI) Compare Nebcin with other medications Bacteremia Bacterial Infection Bone infection Burns, External Cystic Fibrosis Endocarditis Febrile Neutropenia Intraabdominal Infection Kidney Infections Meningitis Peritonitis Pneumonia Rabbit Fever Sepsis Shunt Infection Skin Infection
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NPlate


Pronunciation: roe-mi-PLOE-stim
Generic Name: Romiplostim
Brand Name: NPlate
NPlate is used for:

Treating low platelets (thrombocytopenia) in certain patients with chronic immune thrombocytopenia purpura (ITP).

NPlate is a thrombopoietin (TPO) mimetic protein. It works by helping the bone marrow to increase the number of clot-forming cells (platelets) in the blood. This helps the blood to clot more normally and reduce your risk for excessive or severe bleeding.

Do NOT use NPlate if: you are allergic to any ingredient in NPlate

Contact your doctor or health care provider right away if any of these apply to you.

Before using NPlate:

Some medical conditions may interact with NPlate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have had your spleen removed (splenectomy) if you have blood clotting problems, bleeding problems, or a history of heart attack, stroke, or blood clots in your veins (eg, pulmonary embolism) if you have kidney problems, liver problems, bone marrow problems, a precancerous condition of the blood (eg, myelodysplastic syndrome [MDS]) or blood cancer (eg, leukemia) if you are also taking an anticoagulant or antiplatelet medicine

Some MEDICINES MAY INTERACT with NPlate. However, no specific interactions with NPlate are known at this time.

Ask your health care provider if NPlate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use NPlate:

Use NPlate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

NPlate comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again before each time you use NPlate. NPlate is given as an injection at your doctor's office, hospital, or clinic. You should receive NPlate only under direct medical supervision by a doctor experienced in the use of NPlate. If you miss a dose of NPlate, contact your doctor right away.

Ask your health care provider any questions you may have about how to use NPlate.

Important safety information: NPlate may worsen precancerous conditions of the blood (eg, MDS) and may increase the risk of developing blood cancer. Tell your doctor if you have any of these conditions before you use NPlate. NPlate may increase the risk of high platelet counts and blood clots. Your doctor will perform tests to check for these conditions. Discuss any questions or concerns with your doctor. You may be at greater risk for low platelet counts and bleeding after you stop NPlate, especially if you also take anticoagulants or antiplatelet medicines. Check with your doctor right away if you notice any unusual bleeding or bruising. Lab tests, including complete blood cell counts and bone marrow tests, may be performed while you use NPlate and for at least 2 weeks after you stop using it. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools. Use NPlate with caution in the ELDERLY; they may be more sensitive to its effects. NPlate should be used with extreme caution in CHILDREN; safety and effectiveness in these children have not been confirmed. PREGNANCY AND BREAST-FEEDING: It is not known if NPlate can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using NPlate while you are pregnant. It is not known if NPlate is found in breast milk. Do not breast-feed while taking NPlate. Possible side effects of NPlate:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; headache; indigestion; joint pain; muscle tenderness or weakness; shoulder pain; stomach pain or upset; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blurred vision; chest pain; leg or arm pain; numbness or tingling of the hands and feet; one-sided weakness; severe or persistent dizziness or headache; unusual bruising or bleeding; unusual weakness or tiredness; vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: NPlate side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of NPlate:

NPlate is handled and stored by a health care provider.

General information: If you have any questions about NPlate, please talk with your doctor, pharmacist, or other health care provider. NPlate is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about NPlate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More NPlate resources NPlate Side Effects (in more detail) NPlate Use in Pregnancy & Breastfeeding NPlate Support Group 0 Reviews for NPlate - Add your own review/rating Nplate Prescribing Information (FDA) Nplate Consumer Overview Nplate Monograph (AHFS DI) Nplate Advanced Consumer (Micromedex) - Includes Dosage Information Romiplostim Professional Patient Advice (Wolters Kluwer) Compare NPlate with other medications Idiopathic Thrombocytopenic Purpura
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Anti-Thymocyte Globulin (Rabbit)


Pronunciation: AN-tye THYE-moe-site GLOB-yoo-lin
Generic Name: Anti-Thymocyte Globulin (Rabbit)
Brand Name: Thymoglobulin

Anti-Thymocyte Globulin (Rabbit) should only be given by a doctor in a medical setting under the supervision of a doctor who is experienced in management of organ transplant patients.


Anti-Thymocyte Globulin (Rabbit) is used for:

Treating acute kidney transplant rejection with other medicines used to suppress the immune system. It may also be used for other conditions as determined by your doctor.

Anti-Thymocyte Globulin (Rabbit) is an immune globulin. It works by suppressing the body's immune response, but the way it does this is not fully understood.

Do NOT use Anti-Thymocyte Globulin (Rabbit) if: you are allergic to any ingredient in Anti-Thymocyte Globulin (Rabbit) you are allergic to rabbit products you have an acute viral illness

Contact your doctor or health care provider right away if any of these apply to you.

Before using Anti-Thymocyte Globulin (Rabbit):

Some medical conditions may interact with Anti-Thymocyte Globulin (Rabbit). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have heart failure, shortness of breath, or swelling in the legs if you have low blood platelets or a low white blood cell count if you have high blood sodium or potassium, or kidney or liver problems

Some MEDICINES MAY INTERACT with Anti-Thymocyte Globulin (Rabbit). However, no specific interactions with Anti-Thymocyte Globulin (Rabbit) are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Anti-Thymocyte Globulin (Rabbit) may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Anti-Thymocyte Globulin (Rabbit):

Use Anti-Thymocyte Globulin (Rabbit) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Anti-Thymocyte Globulin (Rabbit) is only administered as an injection by health care providers in a medical setting. If Anti-Thymocyte Globulin (Rabbit) contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it. You may be given other medicines (eg, acetaminophen, corticosteroids, an antihistamine) to decrease the side effects of Anti-Thymocyte Globulin (Rabbit). If you miss a dose of Anti-Thymocyte Globulin (Rabbit), contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Anti-Thymocyte Globulin (Rabbit).

Important safety information: Anti-Thymocyte Globulin (Rabbit) may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Anti-Thymocyte Globulin (Rabbit). Using Anti-Thymocyte Globulin (Rabbit) alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. Anti-Thymocyte Globulin (Rabbit) may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor. Anti-Thymocyte Globulin (Rabbit) may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Do not touch your eyes or the inside of your nose unless you have thoroughly washed your hands first. Notify your doctor of any signs of infection including fever, sore throat, rashes, or chills. Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Anti-Thymocyte Globulin (Rabbit). Anti-Thymocyte Globulin (Rabbit) can affect the results of certain lab tests. Make sure lab personnel and your doctors know you use Anti-Thymocyte Globulin (Rabbit). Check with your doctor before having vaccinations while you are using Anti-Thymocyte Globulin (Rabbit). Carry an identification card at all times that says you taking this medication. LAB TESTS, including blood tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments. Use Anti-Thymocyte Globulin (Rabbit) with caution in CHILDREN. Safety and effectiveness have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Anti-Thymocyte Globulin (Rabbit) during pregnancy. It is unknown if Anti-Thymocyte Globulin (Rabbit) is excreted in breast milk. If you are or will be breast-feeding while you are using Anti-Thymocyte Globulin (Rabbit), check with your doctor or pharmacist to discuss the risks to your baby. Possible side effects of Anti-Thymocyte Globulin (Rabbit):

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Chills; diarrhea; dizziness; fever; general body discomfort; headache; nausea; swelling of the hands and feet; urinary tract infection; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); diarrhea; dizziness; easy bleeding or bruising; fast or irregular heartbeat; fever; infection; joint or muscle pain; persistent sore throat; stomach pain; unusual fatigue.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Anti-Thymocyte Globulin (Rabbit) side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Anti-Thymocyte Globulin (Rabbit):

Anti-Thymocyte Globulin (Rabbit) is usually handled and stored by a health care provider. If you are using Anti-Thymocyte Globulin (Rabbit) at home, store Anti-Thymocyte Globulin (Rabbit) as directed by your pharmacist or health care provider. Keep Anti-Thymocyte Globulin (Rabbit) out of the reach of children and away from pets.

General information: If you have any questions about Anti-Thymocyte Globulin (Rabbit), please talk with your doctor, pharmacist, or other health care provider. Anti-Thymocyte Globulin (Rabbit) is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Anti-Thymocyte Globulin (Rabbit). If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Anti-Thymocyte Globulin (Rabbit) resources Anti-Thymocyte Globulin (Rabbit) Side Effects (in more detail) Anti-Thymocyte Globulin (Rabbit) Use in Pregnancy & Breastfeeding Anti-Thymocyte Globulin (Rabbit) Drug Interactions Anti-Thymocyte Globulin (Rabbit) Support Group 0 Reviews for Anti-Thymocyte Globulin (Rabbit) - Add your own review/rating Thymoglobulin Prescribing Information (FDA) Thymoglobulin rabbit Concise Consumer Information (Cerner Multum) Thymoglobulin Monograph (AHFS DI) Thymoglobulin Advanced Consumer (Micromedex) - Includes Dosage Information Compare Anti-Thymocyte Globulin (Rabbit) with other medications Renal Transplant
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Acova


Generic Name: argatroban (ar GAT roe ban)
Brand Names: Acova

What is Acova (argatroban)?

Argatroban keeps the platelets in your blood from coagulating (clotting) to prevent unwanted blood clots that can occur while receiving heparin

Argatroban is used to treat or prevent blood clots in people who have thrombocytopenia (low levels of platelets in the blood) caused by using heparin. Argatroban is sometimes used in people who are undergoing a procedure called angioplasty (to open blocked arteries).

Argatroban may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Acova (argatroban)? You should not use this medication if you are allergic to argatroban, or if you have any major bleeding from a surgery, injury, or other medical trauma. Argatroban is not expected to be harmful to an unborn baby. However, aspirin is sometimes given with argatroban, and aspirin can cause bleeding when it is taken during the last 3 months of pregnancy. Aspirin can also cause side effects in a newborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Before receiving argatroban, tell your doctor if you have liver disease, a stomach ulcer or bleeding, a bleeding or blood clotting disorder, untreated or uncontrolled high blood pressure, if you have recently had a spinal tap or epidural anesthesia, or if you have recently had major surgery (especially on your eyes, brain, or spinal cord).

Tell your doctor if you are using or receiving blood thinners or any other medications used to treat or prevent blood clots.

Because argatroban keeps your blood from coagulating (clotting) to prevent unwanted blood clots, it can also make it easier for you to bleed, even from a minor injury. Contact your doctor or seek emergency medical attention if you have bleeding that will not stop.

What should I discuss with my health care provider before receiving Acova (argatroban)? You should not receive this medication if you are allergic to argatroban, or if you have any major bleeding from a surgery, injury, or other medical trauma.

To make sure you can safely use argatroban, tell your doctor if you have any of these other conditions:

a stomach ulcer or bleeding;

liver disease;

a bleeding or blood clotting disorder (such as hemophilia);

untreated or uncontrolled high blood pressure (hypertension);

if you have recently had a spinal tap or epidural anesthesia; or

if you have recently had major surgery (especially eye surgery, brain surgery, or spinal cord surgery).

Argatroban is not expected to be harmful to an unborn baby. However, aspirin is sometimes given with argatroban, and aspirin can cause bleeding when it is taken during the last 3 months of pregnancy. Aspirin can also cause side effects in a newborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether argatroban passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby. How is argatroban given?

Argatroban is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Argatroban is sometimes given together with aspirin.

If you are receiving this injection during an angioplasty procedure, the medicine will be given throughout the entire procedure and for up to 24 hours after the procedure.

Argatroban is given around the clock until your blood coagulates properly. Your doctor will test your blood often to determine how long to treat you with argatroban.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Visit your doctor regularly.

Because argatroban keeps your blood from coagulating (clotting) to prevent unwanted blood clots, it can also make it easier for you to bleed, even from a minor injury. Contact your doctor or seek emergency medical attention if you have bleeding that will not stop.

What happens if I miss a dose?

Since argatroban is given by a healthcare professional, you are not likely to miss a dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

What should I avoid while receiving Acova (argatroban)?

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Avoid drinking alcohol. It may increase your risk of bleeding in your stomach or intestines. Acova (argatroban) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

feeling like you might pass out;

easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

blood in your urine;

black, bloody, or tarry stools;

coughing up blood or vomit that looks like coffee grounds;

any bleeding that will not stop;

pain or burning when you urinate;

sudden numbness or weakness, problems with vision, speech, or balance;

sudden severe headache, confusion, sudden changes in your senses of taste or touch;

fever, chills, body aches, flu symptoms;

cough with yellow or green mucus, stabbing chest pain, feeling short of breath;

slow heart rate, weak pulse, slow breathing (breathing may stop); or

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Less serious side effects may include:

nausea, vomiting, diarrhea, stomach pain;

headache;

back pain; or

bleeding around the IV needle.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Acova (argatroban)?

Tell your doctor about all other medications you use or have recently received to prevent blood clots, such as:

a blood thinner such as heparin or warfarin (Coumadin, Jantoven);

abciximab (ReoPro), anagrelide (Agrylin), cilostazol (Pletal), clopidogrel (Plavix), dipyridamole (Persantine, Aggrenox), eptifibatide (Integrelin), prasugrel (Effient), ticlopidine (Ticlid), tirofiban (Aggrastat);

dabigatran (Pradaxa), bivalirudin (Angiomax), lepirudin (Refludan);

dalteparin (Fragmin), enoxaparin (Lovenox), fondaparinux (Arixtra), tinzaparin (Innohep); or

alteplase (Activase), tenecteplase (TNKase), urokinase (Abbokinase).

This list is not complete and other drugs may interact with argatroban. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Acova resources Acova Side Effects (in more detail) Acova Use in Pregnancy & Breastfeeding Acova Drug Interactions Acova Support Group 0 Reviews for Acova - Add your own review/rating Acova Monograph (AHFS DI) Argatroban Prescribing Information (FDA) Argatroban Professional Patient Advice (Wolters Kluwer) Argatroban MedFacts Consumer Leaflet (Wolters Kluwer) argatroban Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information Compare Acova with other medications Thrombotic/Thromboembolic Disorder Where can I get more information? Your doctor or pharmacist can provide more information about argatroban.

See also: Acova side effects (in more detail)


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Ixempra


Generic Name: ixabepilone (IX ab EP i lone)
Brand Names: Ixempra

What is ixabepilone?

Ixabepilone is used to treat advanced breast cancer.

Ixabepilone is usually given after other cancer medications have been tried without successful treatment.

Ixabepilone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about ixabepilone? Do not use ixabepilone if you are pregnant. It could harm the unborn baby. You should not receive this medication if you are allergic to ixabepilone, or to a medication ingredient called Cremophor (synthetic castor oil). You may not be able to receive ixabepilone if you have severe liver disease, or severely low platelets or white blood cell counts.

Before you receive ixabepilone, tell your doctor if you have liver disease, heart disease, nerve problems, diabetes, bone marrow suppression, or a weak immune system.

Ixabepilone can lower blood cells that help your body fight infections. Avoid being near people who are sick or have infections. Your blood may need to be tested often. Visit your doctor regularly.

Tell your doctor at once if you develop signs of infection, such as fever, chills, body aches, flu symptoms, pale skin, easy bruising or bleeding, or sores in your mouth and throat. Avoid drinking alcohol during your treatment with ixabepilone. What should I discuss with my health care provider before receiving ixabepilone? You should not receive this medication if you are allergic to ixabepilone, or to a medication ingredient called Cremophor (synthetic castor oil). You may not be able to receive ixabepilone if you have severe liver disease, or severely low platelets or white blood cell counts.

To make sure you can safely receive ixabepilone, tell your doctor if you have any of these other conditions:

liver disease;

heart disease;

nerve problems (especially in your hands or feet);

diabetes; or

bone marrow suppression or weak immune system.

FDA pregnancy category D. Do not use ixabepilone if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether ixabepilone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while receiving ixabepilone. How is ixabepilone given?

Ixabepilone is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Ixabepilone must be given slowly, and the IV infusion can take up to 3 hours to complete.

Ixabepilone is usually given every 3 weeks.

About 1 hour before you receive ixabepilone, you may be given other medications to help prevent certain side effects.

Ixabepilone can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Visit your doctor regularly.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your ixabepilone injection.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while receiving ixabepilone?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Avoid drinking alcohol during your treatment with ixabepilone. Ixabepilone side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; warmth or tingly feeling; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers at once if you have any of these serious side effects:

numbness, tingling, burning pain, discomfort, or loss of feeling anywhere in your body;

fever, chills, body aches, flu symptoms, sores in your mouth and throat;

easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

sudden numbness or weakness, especially on one side of the body;

sudden severe headache, confusion, problems with vision, speech, or balance;

pain or burning when you urinate;

chest pain or heavy feeling; or

redness, swelling, and pain on the palms of your hands or the soles of your feet.

Less serious side effects include:

tired feeling;

joint or muscle pain;

hair loss;

nausea, vomiting, stomach pain, loss of appetite;

diarrhea or constipation; or

problems with your fingernails or toenails.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect ixabepilone?

Many drugs can interact with ixabepilone. Below is just a partial list. Tell your doctor if you are using:

bosentan (Tracleer);

dexamethasone (Cortastat, DexPak, Solurex);

St. John's wort;

rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), or rifapentine (Priftin);

an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), nafcillin (Nallpen, Unipen), or telithromycin (Ketek);

an antidepressant such as nefazodone;

antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), or voriconazole (Vfend);

a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton);

heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;

HIV /AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), etravirine (Intelence), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), or saquinavir (Invirase, Fortovase);

medicines to treat narcolepsy, such as armodafanil (Nuvigil) or modafanil (Progivil); or

seizure medication such as carbamazepine (Carbatrol, Tegretol), felbamate (Felbatol), fosphenytoin (Cerebyx), oxcarbazepine (Trileptal), phenytoin (Dilantin), or primidone (Mysoline).

This list is not complete and other drugs may interact with ixabepilone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Ixempra resources Ixempra Side Effects (in more detail) Ixempra Use in Pregnancy & Breastfeeding Ixempra Drug Interactions Ixempra Support Group 0 Reviews for Ixempra - Add your own review/rating Ixempra Prescribing Information (FDA) Ixempra Monograph (AHFS DI) Ixempra Advanced Consumer (Micromedex) - Includes Dosage Information Ixempra Consumer Overview Ixempra MedFacts Consumer Leaflet (Wolters Kluwer) Ixabepilone Professional Patient Advice (Wolters Kluwer) Compare Ixempra with other medications Breast Cancer Breast Cancer, Metastatic Where can I get more information? Your doctor or pharmacist can provide more information about ixabepilone.

See also: Ixempra side effects (in more detail)


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Tyvaso Inhalation Solution


Pronunciation: tre-PROST-i-nil
Generic Name: Treprostinil
Brand Name: Tyvaso
Tyvaso Inhalation Solution is used for:

Treating pulmonary arterial hypertension (PAH) (high blood pressure in the arteries of the lungs) in certain patients to increase walk distance. It may also be used for other conditions as determined by your doctor.

Tyvaso Inhalation Solution is a prostacyclin vasodilator. It works by relaxing blood vessels and increasing the supply of blood to the lungs in patients with high blood pressure in the lungs. This decreases how hard the heart must work to pump blood to the lungs. It also prevents the platelets in your blood from clotting to prevent unwanted blood clots.

Do NOT use Tyvaso Inhalation Solution if: you are allergic to any ingredient in Tyvaso Inhalation Solution

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tyvaso Inhalation Solution:

Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have liver or kidney problems, bleeding problems, a lung infection (eg, pneumonia) or breathing problems (eg, asthma or chronic obstructive pulmonary disease [COPD]), or low blood pressure

Some MEDICINES MAY INTERACT with Tyvaso Inhalation Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

Anticoagulants (eg, warfarin) because the risk of side effects, such as bleeding, may occur Blood pressure medicines (eg, lisinopril), diuretics (eg, furosemide), or vasodilators (eg, hydralazine) because the risk of side effects, such as dizziness, fainting, and very low blood pressure, may occur Gemfibrozil because it may increase the risk of Tyvaso Inhalation Solution's side effects Rifampin because it may decrease Tyvaso Inhalation Solution's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tyvaso Inhalation Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tyvaso Inhalation Solution:

Use Tyvaso Inhalation Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Tyvaso Inhalation Solution. Talk to your pharmacist if you have questions about this information. Tyvaso Inhalation Solution should only be used with the Tyvaso inhalation system. Follow the instructions for use and daily cleaning after the last treatment session of the day. Talk to your pharmacist if you have questions about this information. Tyvaso Inhalation Solution is usually used in 4 treatment sessions each day approximately 4 hours apart during waking hours. Follow the dosing schedule given to you by your doctor carefully. Tyvaso Inhalation Solution is inhaled through your mouth into your lungs. Take your first treatment with Tyvaso Inhalation Solution in the morning and take your last treatment session before bedtime unless your doctor tells you otherwise. Talk with your doctor if you need to time your dosing around any planned activities. One ampule of Tyvaso Inhalation Solution contains enough medicine for all 4 treatment sessions. Tyvaso Inhalation Solution should remain in the inhalation system for no more than 24 hours. Any remaining solution should be discarded at the end of the day. Do not mix Tyvaso Inhalation Solution with other medicines in the inhalation device. Avoid skin or eye contact with Tyvaso Inhalation Solution. If Tyvaso Inhalation Solution comes in contact with skin or eyes, rinse immediately with water. Use Tyvaso Inhalation Solution on a regular schedule to get the most benefit from it. If you miss a dose of Tyvaso Inhalation Solution, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Tyvaso Inhalation Solution.

Important safety information: Tyvaso Inhalation Solution may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Tyvaso Inhalation Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Tyvaso Inhalation Solution may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects. Do NOT take more than the recommended dose without checking with your doctor. Stopping Tyvaso Inhalation Solution, even briefly, may lead to serious side effects. To avoid interruption in medicine treatment you should have access to a backup inhalation system. Tyvaso Inhalation Solution may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away. Tyvaso Inhalation Solution may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools. Tell your doctor or dentist that you take Tyvaso Inhalation Solution before you receive any medical or dental care, emergency care, or surgery. If your symptoms do not get better or if they get worse, check with your doctor. Lab tests, including lung function, may be performed while you use Tyvaso Inhalation Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Tyvaso Inhalation Solution with caution in the ELDERLY; they may be more sensitive to its effects. Tyvaso Inhalation Solution should be used with extreme caution in CHILDREN younger than 18 years old years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: It is not known if Tyvaso Inhalation Solution can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tyvaso Inhalation Solution while you are pregnant. It is not known if Tyvaso Inhalation Solution is found in breast milk. If you are or will be breast-feeding while you are using Tyvaso Inhalation Solution, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Tyvaso Inhalation Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cough; diarrhea; dizziness; headache; muscle, jaw, or bone pain; nausea; reddening of the face and neck (flushing); throat irritation or pain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; coughing up blood; dark, tarry, or bloody stools; fainting; fever, chills, or persistent sore throat; increased cough; new or worsening shortness of breath; pale skin; severe or persistent tiredness, weakness, dizziness, headache, or nausea; swelling of the ankles or feet; unusual bruising or bleeding; vomit that looks like coffee grounds; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Tyvaso side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include diarrhea; dizziness; flushing; headache; nausea; vomiting.

Proper storage of Tyvaso Inhalation Solution:

Store Tyvaso Inhalation Solution in the unopened foil pouch at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Once the foil pack is opened, use the ampules within 7 days. Store away from heat, moisture, and light. Keep Tyvaso Inhalation Solution out of the reach of children and away from pets.

General information: If you have any questions about Tyvaso Inhalation Solution, please talk with your doctor, pharmacist, or other health care provider. Tyvaso Inhalation Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Tyvaso Inhalation Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Tyvaso resources Tyvaso Side Effects (in more detail) Tyvaso Use in Pregnancy & Breastfeeding Tyvaso Drug Interactions Tyvaso Support Group 4 Reviews for Tyvaso - Add your own review/rating Compare Tyvaso with other medications Pulmonary Arterial Hypertension
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Hydrea


Generic Name: hydroxyurea (hye DROX ee yoo REE a)
Brand Names: Droxia, Hydrea

What is Hydrea (hydroxyurea)?

Hydroxyurea affects certain cells in the body, such as cancer cells or sickled red blood cells.

Hydroxyurea is used to treat chronic myelocytic leukemia, ovarian cancer, and certain types of skin cancer (melanoma and primary squamous cell cancer of the head and neck).

Hydroxyurea is also used to reduce pain episodes and the need for blood transfusions in people with sickle cell anemia. Hydroxyurea will not cure sickle cell anemia.

Hydroxyurea may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Hydrea (hydroxyurea)? Do not use hydroxyurea if you are pregnant. It could harm the unborn baby. You should not use hydroxyurea if you are allergic to it, or if you have severe bone marrow suppression, severe anemia, or low levels of platelets in your blood.

Before using hydroxyurea, tell your doctor if you have bone marrow suppression, HIV or AIDS, liver or kidney disease, or if you are receiving chemotherapy or radiation.

Wash your hands before and after you handle a hydroxyurea capsule or the bottle that contains the pills. For best protection, wear disposable gloves when handling the pills. Do not open the hydroxyurea capsule. Do not use a pill that has been accidentally opened or broken. The medicine from an open capsule can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water.

If any powder from an open capsule is spilled, wipe it up at once with a damp paper towel and throw the towel away in a sealed plastic bag where children and pets cannot get to it.

Hydroxyurea can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Your kidney or liver function may also need to be tested. Visit your doctor regularly.

What should I discuss with my healthcare provider before taking Hydrea (hydroxyurea)? You should not use hydroxyurea if you are allergic to it, or if you have:

severe bone marrow suppression;

severe anemia; or

low levels of platelets in your blood.

To make sure you can safely take hydroxyurea, tell your doctor if you have any of these other conditions:

bone marrow suppression;

HIV or AIDS;

liver disease; kidney disease; or

if you are receiving chemotherapy or radiation.

FDA pregnancy category D. Do not use hydroxyurea if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. This medication may affect fertility (your ability to have children), whether you are a man or a woman. Hydroxyurea can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking hydroxyurea. Older adults may be more likely to have side effects from this medicine. How should I take Hydrea (hydroxyurea)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

Drink 8 to 10 glasses of liquid per day while you are taking hydroxyurea. You may take the medicine with or without food.

Hydroxyurea is either taken once per day or once every third day, depending on the condition being treated. On each of your dosing days, take the medicine at the same time of day. Your doctor may also want you to take a folic acid supplement. Follow your doctor's instructions very carefully.

Wash your hands before and after you handle a hydroxyurea capsule or the bottle that contains the pills. For best protection, wear disposable gloves when handling the pills. Do not open the hydroxyurea capsule. Do not use a pill that has been accidentally opened or broken. The medicine from an open capsule can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water.

If any powder from an open capsule is spilled, wipe it up at once with a damp paper towel and throw the towel away in a sealed plastic bag where children and pets cannot get to it.

Hydroxyurea can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.

To make sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your treatments may be delayed based on the results of these tests. Do not miss any follow-up visits to your doctor.

Use hydroxyurea regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

See also: Hydrea dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include drowsiness, mouth sores, and swelling with pain and purple discoloration in your hands and feet.

What should I avoid while taking Hydrea (hydroxyurea)?

Do not handle hydroxyurea pills or the medicine bottle without skin protection (disposable gloves).

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Hydrea (hydroxyurea) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

fever, chills, body aches, flu symptoms, sores in your mouth and throat;

easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

skin redness, skin ulcers, or open sores;

painful or difficult urination;

confusion, hallucinations, seizure; or

nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes).

Less serious side effects may include:

hair loss;

skin peeling or discoloration, mild rash;

upset stomach, constipation, diarrhea;

headache, dizziness; or

weight gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Hydrea (hydroxyurea)?

Some medicines can increase your risk of certain side effects while taking hydroxyurea. Tell your doctor if you are also using:

didanosine (Videx);

stavudine (Zerit); or

an interferon such as Actimmune, Alferon, Avonex, Betaseron, Extavia, Infergen, Intron, Rebetron, Rebif, or Roferon.

This list is not complete and other drugs may interact with hydroxyurea. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Hydrea resources Hydrea Side Effects (in more detail) Hydrea Dosage Hydrea Use in Pregnancy & Breastfeeding Drug Images Hydrea Drug Interactions Hydrea Support Group 2 Reviews for Hydrea - Add your own review/rating Hydrea Advanced Consumer (Micromedex) - Includes Dosage Information Hydrea MedFacts Consumer Leaflet (Wolters Kluwer) Hydrea Prescribing Information (FDA) Hydroxyurea Prescribing Information (FDA) Hydroxyurea Monograph (AHFS DI) Hydroxyurea Professional Patient Advice (Wolters Kluwer) Droxia MedFacts Consumer Leaflet (Wolters Kluwer) Droxia Prescribing Information (FDA) Compare Hydrea with other medications Anemia, Sickle Cell Chronic Myelogenous Leukemia Solid Tumors Where can I get more information? Your pharmacist can provide more information about hydroxyurea.

See also: Hydrea side effects (in more detail)


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Pemetrexed


Pronunciation: PEM-e-TREX-ed
Generic Name: Pemetrexed
Brand Name: Alimta
Pemetrexed is used for:

Treating malignant pleural mesothelioma and certain types of non-small cell lung cancer in certain patients. It may be used alone or in combination with cisplatin (another anticancer medicine).

Pemetrexed is an antifolate antineoplastic agent. It works by decreasing tumor cell growth.

Do NOT use Pemetrexed if: you are allergic to any ingredient in Pemetrexed you have severe kidney problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pemetrexed:

Some medical conditions may interact with Pemetrexed. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are able to become pregnant if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have liver or kidney problems, bone marrow problems, diarrhea, an infection, or blood problems (eg, low platelets, low white blood cell count) if you have a history of radiation treatment

Some MEDICINES MAY INTERACT with Pemetrexed. Tell your health care provider if you are taking any other medicines, especially any of the following:

Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), probenecid, or medicines that may harm the kidney (eg, aminoglycoside antibiotics [gentamicin], amphotericin B, cyclosporine, tacrolimus, vancomycin) because they may increase the risk of Pemetrexed's side effects. Ask your doctor if you are unsure if any of your medicines might harm the kidney

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pemetrexed may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pemetrexed:

Use Pemetrexed as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Pemetrexed comes with an additional patient leaflet. Read it carefully and reread it each time you get Pemetrexed refilled. Pemetrexed is usually given as an injection at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions. Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal. If you miss a dose of Pemetrexed, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Pemetrexed.

Important safety information: Pemetrexed may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills. If you also take an NSAID (eg, naproxen), you may need to stop taking it for a period of time before you receive Pemetrexed. You will also need to wait for 2 days after you receive Pemetrexed before you begin to take the NSAID again. Check with your doctor for instructions. If you are unsure if any of your medicines are NSAIDs, ask your doctor or pharmacist. If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does. Your doctor will instruct you to take other medicines, such as folic acid, vitamin B12, or corticosteroids (eg, dexamethasone), to reduce the severity of some side effects associated with Pemetrexed. Follow the instructions for taking these medicines closely. If diarrhea, nausea, vomiting, or appetite loss occurs, contact your doctor or pharmacist for ways to lessen these effects. You may get redness or sores in your mouth, throat, or on your lips a few days after treatment with Pemetrexed. Contact your doctor or pharmacist about proper mouth and throat care. Pemetrexed may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools. Do not get Pemetrexed on your skin. If Pemetrexed spills on your skin, wash immediately with soap and water. Clean any areas (tables, counters) where Pemetrexed may have spilled or sprayed. If you are able to become pregnant, be sure to use an effective form of birth control while using Pemetrexed. Contact your doctor or pharmacist if you have any questions about effective birth control. Lab tests, including complete blood cell counts and kidney and liver function, may be performed while you use Pemetrexed. These tests may be used to monitor your progress or check for side effects. Be sure to keep all doctor and lab appointments. Use Pemetrexed with caution in the ELDERLY; they may be more sensitive to its effects. Pemetrexed should be used with extreme caution in CHILDREN; safety and effectiveness have not been confirmed. PREGNANCY and BREAST-FEEDING: Pemetrexed may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pemetrexed while you are pregnant. It is not known if Pemetrexed is found in breast milk. Do not breast-feed while taking Pemetrexed. Possible side effects of Pemetrexed:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; hair loss; indigestion; loss of appetite; mild sore throat; nausea; pain, swelling, or redness at the injection site; taste changes; tiredness or weakness; vomiting; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling; chest pain; chills; decreased amount of urine; fever; irregular heartbeat; mood or mental changes; mouth, throat, or lip sores; persistent cough; persistent sore throat; red, swollen, blistered, or peeling skin; severe or persistent diarrhea, nausea, vomiting, or stomach pain; severe or persistent tiredness or weakness; shortness of breath; swelling of the hands, ankles, or feet; symptoms of dehydration (eg, sluggishness, very dry mouth or eyes); trouble swallowing; unusual bruising or bleeding; unusually pale skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Pemetrexed side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms of overdose may include diarrhea; infection with or without fever; inflammation or sores in the mouth or throat; rash; severe tiredness or weakness; unusual bruising or bleeding.

Proper storage of Pemetrexed:

Pemetrexed is usually handled and stored by a health care provider. If you are using Pemetrexed at home, store Pemetrexed as directed by your pharmacist or health care provider. Keep Pemetrexed out of the reach of children and away from pets.

General information: If you have any questions about Pemetrexed, please talk with your doctor, pharmacist, or other health care provider. Pemetrexed is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Pemetrexed. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Pemetrexed resources Pemetrexed Side Effects (in more detail) Pemetrexed Use in Pregnancy & Breastfeeding Pemetrexed Drug Interactions Pemetrexed Support Group 0 Reviews for Pemetrexed - Add your own review/rating Pemetrexed Professional Patient Advice (Wolters Kluwer) Alimta Prescribing Information (FDA) Alimta Monograph (AHFS DI) Alimta Consumer Overview pemetrexed Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information Compare Pemetrexed with other medications Malignant Pleural Mesothelioma Non-Small Cell Lung Cancer
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Rapamune 1mg / ml Oral Solution


Rapamune 1mg/ml oral solution.

Sirolimus

Please read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any other effects not mentioned in this leaflet, please tell your doctor or pharmacist. In this leaflet:

1. What Rapamune is and what it is used for
2. Before you take Rapamune
3. How to take Rapamune
4. Possible side effects
5. How to store Rapamune
6. Further information

What Rapamune Is And What It Is Used For

Rapamune belongs to a group of medicines called immunosuppressants. It helps to control your body’s immune system after you have received an organ transplant. It is used to prevent your body from rejecting transplanted kidneys and is normally used with medicines called corticosteroids and initially with ciclosporin.

Before You Take Rapamune Do not take Rapamune if you are allergic (hypersensitive) to sirolimus or any of the other ingredients of Rapamune. Take special care with Rapamune if you have any liver problems or have had a disease which may have affected your liver, please tell your doctor as this may affect the dose of Rapamune that you receive. immunosuppressive medicines may decrease your body’s ability to fight infection, and may increase the risk of developing cancer of the lymphoid tissues and skin.

Your doctor will perform tests to monitor the levels of Rapamune in your blood. Your doctor will also perform tests to monitor your kidney function, your blood fat (cholesterol and/or triglycerides) levels and, possibly, your liver function, during therapy with Rapamune.

Exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor because of the increased risk for skin cancer.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines, including those obtained without a prescription. Some medicines can interfere with the action of Rapamune. In particular, you should inform your doctor or pharmacist if you are taking any of the following:

any other immunosuppressive agents excluding ciclosporin or corticosteroids. antibiotics or antifungal medicines used to treat infection e.g. rifampicin, clarithromycin, erythromycin, telithromycin, troleandomycin, rifabutin, clotrimazole, fluconazole, itraconazole, ketoconazole and voriconazole. high blood pressure medicines or medicines for heart problems including nicardipine, verapamil and diltiazem. anti-epileptic medicines including carbamazepine, phenobarbital, phenytoin. medicines used to treat-ulcers or other gastrointestinal disorders such as cisapride, cimetidine, metoclopramide. bromocriptine (used in the treatment of Parkinsons’ disease and various hormonal disorders), danazol (used in the treament of gynaecological disorders), or protease inhibitors (used in the treatment of HIV). St. John’s Wort (Hypericum perforatum).

The use of Rapamune may lead to increased blood concentrations of cholesterol and triglycerides that may require treatment. Medicines known as “statins” and “fibrates” used to treat elevated cholesterol and triglycerides have been associated with an increased risk of muscle breakdown (rhabdomyolysis). Please inform your doctor if you are taking drugs to lower your blood fats.

Taking Rapamune with food and drink

Rapamune should be taken consistently, either with or without food. Rapamune should be diluted only with water or orange juice. Do not take Rapamune with grapefruit juice.

Pregnancy and breast feeding

You must use effective contraception methods during treatment with Rapamune and for 12 weeks after treatment has stopped. If you are unsure, or think you may have become pregnant, talk to your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Decreased sperm count has been associated with the use of Rapamune and usually resolves after discontinuation.

It is not known whether Rapamune passes into breast milk. Patients taking Rapamune should discontinue breast-feeding.

Use in children and adolescents

There is limited experience with the administration of Rapamune in children and adolescents.

Driving and using machines

No specific studies on the effects of Rapamune on the ability to drive and use machines have been conducted. Although Rapamune treatment is not expected to affect your ability to drive, if you have any concerns please consult your doctor.

Important information about one of the ingredients of Rapamune

WARNING: This medicine contains 1.5% to 2.5% ethanol. Each 2 mg dose contains up to 50 mg of alcohol. Alcohol may be harmful for those suffering from alcoholism, epilepsy, brain injury or disease as well as for pregnant women and children. Alcohol may modify or increase the effect of other medicines.

How To Take Rapamune

Rapamune is for oral use only. Always take Rapamune exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Your doctor will decide exactly what dose of Rapamune you must take and how often to take it. Follow your doctor’s instructions exactly and never change the dose yourself. Do not stop taking your medicine unless your doctor tells you to. If you stop taking your medicine, you risk losing your transplant.

Usually for an adult your doctor will give you an initial dose of 6 mg as soon as possible after the kidney transplant operation. Then you will need to take 2 mg of Rapamune each day, unless otherwise directed by your doctor. Your dose will be adjusted depending on the level of Rapamune in your blood. Your doctor will need to perform a blood test to measure Rapamune concentrations.

If you are also taking ciclosporin, then you must take the two medicines approximately 4 hours apart.

Instructions on how to dilute Rapamune

1. Remove the safety cap from the bottle by squeezing the tabs on the cap and twisting. Insert the syringe adapter into the bottle until it is flush with the top of the bottle. Do not attempt to remove the syringe adapter from the bottle once inserted.

2. With the plunger fully depressed, insert one of the dosing syringes into the opening in the adapter.

3. Withdraw the exact amount of Rapamune oral solution as prescribed by your doctor by gently pulling out the plunger of the dosing syringe until the bottom of the black line of the plunger is level with the appropriate mark on the dosing syringe. The bottle should remain in an upright position when withdrawing the solution. If bubbles form in the dosing syringe during withdrawal, empty the Rapamune solution back into the bottle and repeat the withdrawal procedure.

4. You may have been instructed to take your Rapamune oral solution at a particular time of day. If it is necessary to carry your medication with you, fill the dosing syringe to the appropriate mark and place a cap securely on it – the cap should snap into place. Then place the capped dosing syringe in the carrying case provided. Once in the syringe the medication may be kept at room temperature (not exceeding 25°C) or refrigerated and should be used within 24 hours.

Empty the contents of the dosing syringe into only a glass or plastic container holding at least 60 ml of water or orange juice. Stir well for one minute and drink immediately. Refill the glass with at least 120 ml of water or orange juice, stir well, and drink immediately. No other liquids, including grapefruit juice, should be used for dilution. The dosing syringe and cap are to be used once and then discarded.

When refrigerated the solution in the bottle may develop a slight haze. If this occurs, simply bring your Rapamune 1 mg/1 ml oral solution to room temperature and shake gently. The presence of this haze does not affect the quality of Rapamune.

If you take more Rapamune than you should

If you have taken more medicine than you were told contact a doctor or go to the nearest hospital emergency department straight away. Always take the labelled medicine bottle with you, even if it is empty.

If you forget to take Rapamune

If you forget to take Rapamune, take it as soon as you remember, but not within 4 hours of the next dose of ciclosporin. After that, continue to take your medicines as usual. Do not take a double dose to make up for a forgotten dose, and always take Rapamune and ciclosporin approximately 4 hours apart. If you miss a dose of Rapamune completely, you should inform your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, Rapamune can cause side effects, although not everybody gets them. However, since Rapamune is taken in combination with other medicines, the side effects cannot always be attributed with absolute certainty to Rapamune. When taken with medicines called calcineurin inhibitors (ciclosporin or tacrolimus), Rapamune may increase the risk of kidney damage with low blood platelets and low red blood cell counts with or without rash (thrombocytopenic purpura/haemolytic uraemic syndrome).

Immunosuppressants, including Rapamune, reduce your body’s own defence mechanisms to stop you rejecting your transplanted organ. Consequently your body will not be as good as normal at fighting infections. So if you are taking Rapamune you may therefore catch more infections than usual such as infections of the skin, mouth, stomach and intestines, lungs and urinary tract.

Possible side effects of Rapamune are listed according to the following categories:

Very common: more than 1 per 10

Common: less than 1 per 10 but more than 1 per 100

Uncommon: less than 1 per 100 but more than 1 per 1000

Rare: less than 1 per 1000

Body as a whole:

Very common: Fluid collection around the kidney, swelling of the extremities, fever, pain

Common: Impaired healing (this may include separation of the layers of a surgical wound or suture line), swelling, infections (including life-threatening infections)

Nervous system disorders:

Very common: Headache

Cardiac disorders:

Common: Rapid heart rate

Uncommon: Fluid collection in the sac around the heart that, in some cases, may decrease the heart's ability to pump blood

Blood vessel disorders:

Very common: Increased blood pressure

Common: Blood clots in the legs

Uncommon: Blood clots in the lung

Gastrointestinal reactions

Very common: Abdominal pain, diarrhea, constipation, nausea

Common: Mouth sores, fluid collection in the abdomen

Uncommon: Inflammation of the pancreas

Blood and lymph disorders:

Very common: Low red blood cells, low blood platelets

Common: Kidney damage with low blood platelets and low red blood cell counts with or without rash (thrombocytopenic purpura/haemolytic uraemic syndrome), a reduced number of infection fighting cells in the blood (white blood cells), low levels of a type of white blood cells called neutrophils

Uncommon: Cancer of the lymph tissue (lymphoma/post-transplant lympho-proliferative disorder), combined lowering of red blood cells, white blood cells and blood platelets

Rare: Too much fluid collecting in the tissues due to irregular lymph function

Immune system disorders:

Rare: Allergic reactions including those that are life-threatening

Metabolism and nutrition disorders:

Very common: Elevated cholesterol, elevated blood sugar, elevated fat in the blood, low blood potassium, low blood phosphorus, elevated lactate dehydrogenase protein in the blood, elevated creatinine in the blood

Common: Diabetes, abnormal tests of liver function, elevated AST and/or ALT liver enzymes

Bone and joint disorders:

Very common: Joint pain

Common: Deterioration of bone

Respiratory tract disorders:

Common: Pneumonia and other causes of inflammation that may lead to lung damage, fluid around the lung, nose bleeds

Uncommon: Bleeding from the lung.

Rare: Protein build-up in the air sacs of the lungs that may interfere with breathing

Skin disorders:

Very common: Acne

Common: Skin cancer, rash

Kidney disorders:

Very common: Urinary tract infection

Common: Kidney infection; protein in the urine

Uncommon: Protein in the urine, occasionally severe and associated with side effects such as swelling

There is a general tendency for fluid to collect in various tissues.

Serious liver damage has also been reported.

Scarring in the kidney that may reduce kidney function has been reported.

The above side effects may require medical intervention and some may be life-threatening or fatal.

You should see your doctor immediately if you experience symptoms such as swollen face, tongue and/or pharynx (back of the mouth) and/or difficulties in breathing (angioedema), or a skin condition whereby the skin can peel off (exfoliative dermatitis). If you are concerned about any side effect or if you notice any other effects not mentioned in this leaflet, please inform your doctor or pharmacist.

How To Store Rapamune

Keep out of the reach and sight of children.

Do not use Rapamune after the expiry date which is stated on the carton after EXP:. The expiry date refers to the last day of that month.

Keep Rapamune oral solution in its original bottle in order to protect from light. Store in a refrigerator (2°C - 8°C). Once the bottle has been opened, the contents should be kept refrigerated and used within 30 days. If necessary, you may store the bottles at room temperature up to 25°C for a short period of time (no longer than 24 hours).

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information What Rapamune contains

The active substance is sirolimus. Each ml of Rapamune contains 1 mg of sirolimus.

The other ingredients are:

Polysorbate 80 and phosal 50 PG (phosphatidylcholine, propylene glycol, monodiglycerides, ethanol (1.5% to 2.5%), soya fatty acids, and ascorbyl palmitate).

What Rapamune looks like and contents of the pack

Rapamune oral solution is supplied in 60 ml amber glass bottles.

Marketing authorisation holder: Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom Manufacturer: Wyeth Medica Ireland Little Connell Newbridge Co. Kildare Ireland

Or

Wyeth Pharmaceuticals New Lane Havant Hampshire PO9 2NG United Kingdom

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

United Kingdom Wyeth Pharmaceuticals Tel:+44 1628 415330 Fax:+44 1628 414802

This leaflet was last approved in: 07/2010

Detailed information on this medicine is available on the European Medicines Agency (EMA) website: http://www.emea.europa.eu

Doc ID 61545 (Clean version of 61544)


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GamaSTAN S/D IGIM


Generic Name: immune globulin (intramuscular) (IGIM) (i MUNE GLOB ue lin (IN tra MUS cue lar))
Brand Names: GamaSTAN S/D

What is IGIM?

Immune globulin for intramuscular administration (IGIM) is a sterilized solution obtained from pooled human blood. It contains the immunoglobulins (or antibodies) to protect against infectious agents that cause various diseases. Antibodies are substances in the blood that fight infections.

IGIM is used to prevent or reduce the severity of infection by hepatitis A, measles, chickenpox (varicella), and rubella. IGIM is also used to prevent or reduce the severity of other infections in individuals with immunoglobulin deficiencies.

IGIM may also be used for purposes other than those listed here.

What is the most important information I should know about IGIM?

IGIM is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although IGIM is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using IGIM.

What should I discuss with my healthcare provider before using IGIM? Do not use IGIM without first talking to your doctor if you have

IgA deficiency;

previously had an allergic reaction to an immune globulin product;

a low level of platelets in the blood (thrombocytopenia); or

a bleeding or blood clotting disorder.

You may not be able to use IGIM, or you may require a dosage adjustment or special monitoring during treatment.

IGIM is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not use IGIM without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether IGIM passes into breast milk. Do not use IGIM without first talking to your doctor if you are breast-feeding a baby. How should I use IGIM?

IGIM will be administered as an intramuscular (into a muscle) injection by a healthcare provider in a hospital or clinic setting.

Your doctor may want you to have blood tests or other forms of monitoring during treatment with IGIM to monitor progress and side effects.

Your healthcare provider will store IGIM as directed by the manufacturer. If you are storing IGIM at home, your healthcare provider will give you storage instructions.

What happens if I miss a dose?

Contact your healthcare provider if a dose of IGIM is missed.

What happens if I overdose? Seek emergency medical attention or contact your healthcare provider if an overdose of IGIM is suspected.

No information is available regarding symptoms of an overdose of IGIM.

What should I avoid while taking IGIM? Do not receive vaccines that use live strains of the virus (e.g., measles, mumps, and rubella or MMR) during and for three months following treatment with IGIM. These vaccines may not work properly when IGIM has been recently administered. IGIM side effects

IGIM is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although IGIM is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using IGIM.

Notify your doctor immediately if you experience a rare but serious allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to IGIM.

Other less serious side effects may also occur. Upon injection of the medication, some patients experience pain, tenderness, or irritation at the injection site.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect IGIM? Do not receive vaccines that use live strains of the virus (e.g., measles, mumps, and rubella or MMR) during and for three months following treatment with IGIM. These vaccines may not work properly when IGIM has been recently administered.

It is not known whether other medications will interact with IGIM. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products during treatment with IGIM.

Where can I get more information? Your pharmacist can provide more information about immune globulin intramuscular.
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samarium sm 153 lexidronam Intravenous


sa-MAR-ee-um Sm 153 lex-ID-roe-nam

Commonly used brand name(s)

In the U.S.

Quadramet

Available Dosage Forms:

Injectable Solution

Therapeutic Class: Radiopharmaceutical, Antineoplastic

Uses For samarium sm 153 lexidronam

Samarium Sm 153 lexidronam is a radiopharmaceutical. Radiopharmaceuticals are radioactive agents that may be used to diagnose some diseases by studying the function of the body's organs or to treat certain diseases.

Samarium Sm 153 lexidronam is used to help relieve the bone pain that may occur with certain kinds of cancer. The radioactive samarium is taken up in the bone cancer area and gives off radiation that helps provide relief of pain.

Samarium Sm 153 lexidronam is to be given only by or under the direct supervision of a doctor with specialized training in nuclear medicine or radiation oncology.

Before Using samarium sm 153 lexidronam

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For samarium sm 153 lexidronam, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to samarium sm 153 lexidronam or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on samarium sm 153 lexidronam have been done only in adult patients, and there is no specific information comparing use of samarium Sm 153 lexidronam in children with use in other age groups.

Geriatric

Samarium Sm 153 lexidronam has been used in older people and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy Pregnancy Category Explanation All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of samarium Sm 153 lexidronam. Make sure you tell your doctor if you have any other medical problems.

Proper Use of samarium sm 153 lexidronam

Your doctor may have special instructions for you to follow to get ready for your treatment. If you do not understand them or if you have not received such instructions, check with your doctor in advance.

This radiopharmaceutical may accumulate in your bladder. Therefore, to increase the flow of urine and lessen the amount of radiation to your bladder your doctor may instruct you to drink plenty of liquids before receiving samarium Sm 153 lexidronam and urinate often afterwards.

If you have a problem controlling your bladder, tell your doctor before receiving samarium Sm 153 lexidronam. Special precautions will need to be taken to prevent radiation contamination of clothing, bed linens, and the environment.

Dosing

The dose of samarium sm 153 lexidronam will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of samarium sm 153 lexidronam. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Precautions While Using samarium sm 153 lexidronam

It is very important that your doctor check your progress at regular visits to make sure that samarium sm 153 lexidronam is working properly and to check for unwanted effects. You may need to have blood tests done regularly.

Follow these guidelines for 12 hours after receiving samarium Sm 153 lexidronam, to help reduce the chance of contaminating other persons or the environment with radiation:

Use a normal toilet, if available, instead of a urinal. Samarium Sm 153 lexidronam is passed mainly in the urine. To prevent contamination of your home environment, flush the toilet twice after using. Wipe any spilled urine with a tissue and flush it away. Wash your hands after using or cleaning the toilet. Wash your clothes and bed linens immediately, if they become soiled with your urine or blood. Wash them separately from other clothes. If you cut yourself, wash away any spilled blood.

Samarium Sm 153 lexidronam can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If your blood count becomes abnormally low, there are certain precautions you can take to reduce the risk of infection or bleeding, such as:

With abnormally low white blood cell counts: If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination. Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done. Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime. With abnormally low platelet blood counts: Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin. Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters. Avoid contact sports or other situations where bruising or injury could occur. samarium sm 153 lexidronam Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Blood problems, such as a decrease in the number of white blood cells or platelets, may occur in some patients using samarium Sm 153 lexidronam.

Check with your doctor immediately if any of the following side effects occur:

More common Black, tarry stools blood in urine or stools cough or hoarseness fever or chills lower back or side pain painful or difficult urination pinpoint red spots on skin unusual bleeding or bruising

Check with your doctor as soon as possible if any of the following side effects occur:

Less common Irregular heartbeat

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common Increase in bone pain (transient) nausea and vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More samarium sm 153 lexidronam Intravenous resources Samarium sm 153 lexidronam Intravenous Drug Interactions Samarium sm 153 lexidronam Intravenous Support Group 0 Reviews · Be the first to review/rate this drug
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Soltamox Solution


Generic Name: Tamoxifen (ta-MOX-i-fen)
Brand Name: Soltamox

Women taking Soltamox Solution to decrease the risk of developing breast cancer have developed cancer of the uterus, stroke, and blood clots in the lung. Some of these events have been fatal. Contact your doctor right away if you develop any of the following: unusual vaginal bleeding or discharge; abnormal menstrual period; groin pressure or pain; chest pain; shortness of breath; coughing up blood; confusion; one-sided weakness; vision or speech problems.

Women at high risk of breast cancer or with ductal carcinoma in situ (DCIS) should discuss the use of Soltamox Solution with their doctor. Decide if the possible benefits (reducing the risk of breast cancer) outweigh the risk of these events. The benefits of Soltamox Solution outweigh the risks in women who already have breast cancer.


Soltamox Solution is used for:

Treating breast cancer that has spread to other sites in the body.It is also used along with other medicines to treat other types of breast cancer. It is used in women who are at high risk for breast cancer and in women with DCIS (after surgery and radiation) to decrease the risk of developing breast cancer. It may also be used for other conditions as determined by your doctor.

Soltamox Solution is an antiestrogen. It works by blocking the effect of estrogen on certain tumors. This may prevent the growth of tumors that are activated by estrogen.

Do NOT use Soltamox Solution if: you are allergic to any ingredient in Soltamox Solution you are using Soltamox Solution to reduce your risk of breast cancer and you have a history of blood clots in the lung or leg you are using Soltamox Solution to reduce your risk of breast cancer and you also take certain anticoagulants (eg, warfarin) you are taking anastrozole

Contact your doctor or health care provider right away if any of these apply to you.

Before using Soltamox Solution:

Some medical conditions may interact with Soltamox Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of blood clots in the legs or lungs if you have high levels of calcium in your blood, a weakened immune system, or low levels of white blood cells or platelets in your blood if you have high cholesterol or lipid levels if you have cataracts or other vision problems if you are using cytotoxic cancer medicines if you are confined to a bed or chair

Some MEDICINES MAY INTERACT with Soltamox Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

Anticoagulants (eg, warfarin) because the risk of bleeding may be increased Cytotoxic cancer medicines (eg, cisplatin) because the risk of developing blood clots may be increased Rifampin because it may decrease Soltamox Solution's effectiveness Fluorouracil or mitomycin C because they may increase the risk of Soltamox Solution's side effects Aromatase inhibitors (eg, anastrozole, letrozole) because their effectiveness may be decreased by Soltamox Solution

This may not be a complete list of all interactions that may occur. Ask your health care provider if Soltamox Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Soltamox Solution:

Use Soltamox Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Soltamox Solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Soltamox Solution refilled. Soltamox Solution may be taken by mouth with or without food. Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose. Continue to take Soltamox Solution even if you feel well. Do not miss any doses. Taking Soltamox Solution at the same time each day will help you to remember to take it. If you miss a dose of Soltamox Solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Soltamox Solution.

Important safety information: Soltamox Solution may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Soltamox Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Soltamox Solution may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools. Soltamox Solution may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills. New tumors have occurred in body sites other than the uterus in patients taking Soltamox Solution. It is unknown if Soltamox Solution may be the cause. Discuss any questions or concerns with your doctor. Women who take Soltamox Solution to reduce the risk of breast cancer should have a breast exam, mammogram, and gynecological exam before starting and during treatment with Soltamox Solution. Women who may become pregnant should begin taking Soltamox Solution during a menstrual period. Women who have irregular menstrual periods should have a pregnancy test immediately before starting Soltamox Solution. Talk to your doctor if you have any questions about how to begin taking Soltamox Solution. Women who may become pregnant must use effective nonhormonal birth control (eg, condoms, diaphragm) during sexual intercourse while they are taking Soltamox Solution and for 2 months after they stop taking it. Do not use hormonal birth control (eg, birth control pills); it may not work as well while you are taking Soltamox Solution. Discuss any questions about effective nonhormonal birth control with your doctor. Soltamox Solution will not prevent you from becoming pregnant. Lab tests, including breast exams, mammograms, gynecologic exams,complete blood counts, and liver function tests, may be performed while you use Soltamox Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Soltamox Solution should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: Soltamox Solution may cause harm to the fetus. Do not become pregnant while you are using it and for 2 months after you stop using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Soltamox Solution while you are pregnant. It is not known if Soltamox Solution is found in breast milk. Do not breast-feed while taking Soltamox Solution. Possible side effects of Soltamox Solution:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bone pain; constipation; coughing; hot flashes; muscle pain; nausea; tiredness; vaginal discharge; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unexplained hoarseness); abnormal menstrual periods; abnormal vaginal bleeding or bloody discharge; chest pain; coughing up blood; dark urine; decreased sexual desire or ability; depression; fever, chills, or persistent sore throat; groin or pelvic pain or pressure; loss of appetite; loss of balance or coordination; missed menstrual period; new or increased breast tumor or pain; new or unusual lumps; one-sided weakness; pain or swelling in one or both legs; red, swollen, blistered, or peeling skin; severe or persistent tiredness or weakness; shortness of breath; skin changes; stomach pain; sudden severe headache; swelling of the arms or the legs; unusual bleeding or bruising; vision or speech problems; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Soltamox side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include exaggerated reflexes; seizures; severe or persistent dizziness; tremor; trouble breathing; trouble walking.

Proper storage of Soltamox Solution:

Store Soltamox Solution at room temperature, below 77 degrees F (25 degrees C), in the original container. Do NOT refrigerate or freeze. Store away from moisture, heat, and light. Do not store in the bathroom. Throw away any unused medicine 3 months after the bottle is opened. Keep Soltamox Solution out of the reach of children and away from pets.

General information: If you have any questions about Soltamox Solution, please talk with your doctor, pharmacist, or other health care provider. Soltamox Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Soltamox Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Soltamox resources Soltamox Side Effects (in more detail) Soltamox Dosage Soltamox Use in Pregnancy & Breastfeeding Soltamox Drug Interactions Soltamox Support Group 0 Reviews for Soltamox - Add your own review/rating Compare Soltamox with other medications Breast Cancer Breast Cancer, Adjuvant Breast Cancer, Male Breast Cancer, Metastatic Breast Cancer, Palliative McCune-Albright Syndrome Precocious Puberty
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Fondaparinux


Pronunciation: fon-DAP-a-rin-ux
Generic Name: Fondaparinux
Brand Name: Arixtra

Tell your doctor you use Fondaparinux before you have any type of spinal puncture or epidural/spinal anesthesia. Patients who have these procedures while they use Fondaparinux are at risk of developing a blood clot on or near the spinal cord. This could result in long-term or permanent paralysis.

The risk is increased in patients who have an indwelling epidural catheter, traumatic or repeated epidural or spinal puncture, a history of a deformed spine or spinal surgery, and in patients who use medicines that may affect blood clotting, such as warfarin, aspirin, platelet inhibitors (eg, clopidogrel), and nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen).

If you have a spinal puncture or epidural/spinal anesthesia while you use Fondaparinux, tell your doctor immediately if you notice any signs or symptoms of nerve problems, such as numbness or tingling, muscle weakness, or paralysis.


Fondaparinux is used for:

Preventing blood clots in patients who will be having certain types of surgery. Fondaparinux is also used with warfarin to treat blood clots in the leg or lungs. It may also be used for other conditions as determined by your doctor.

Fondaparinux is an anticoagulant. It works by inhibiting one of the steps necessary for the formation of blood clots, which helps prevent clots from developing or worsening.

Do NOT use Fondaparinux if: you are allergic to any ingredient in Fondaparinux you have severe kidney problems, inflammation of the heart due to a bacterial infection (eg, bacterial endocarditis), active major bleeding, or severe bleeding problems you have a low platelet count and the presence of antiplatelet antibodies you weigh less than 110 pounds (50 kg) and are using Fondaparinux to treat a blood clot in the lungs or legs you weigh less than 110 pounds (50 kg) and will be having hip or knee replacement surgery or abdominal surgery, or you have had a hip fracture

Contact your doctor or health care provider right away if any of these apply to you.

Before using Fondaparinux:

Some medical conditions may interact with Fondaparinux. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances (eg, latex) if you have a history of kidney problems, liver problems, stomach or intestinal problems (eg, ulcers), stroke, or vision problems caused by diabetes if you have a bleeding disorder; a history of brain bleeding or blood conditions; severe, uncontrolled high blood pressure; or low body weight if you have recently had or are scheduled to have brain, spine, or eye surgery; an epidural catheter; or a spinal puncture if you are taking medicines that affect platelets (eg, aspirin, clopidogrel, ticlopidine)

Some MEDICINES MAY INTERACT with Fondaparinux. Tell your health care provider if you are taking any other medicines, especially any of the following:

Activated protein C (eg, drotrecogin alfa), anticoagulants (eg, warfarin), direct factor Xa inhibitors (eg, rivaroxaban), direct thrombin inhibitors (eg, dabigatran), NSAIDs (eg, ibuprofen, ketorolac, naproxen), platelet inhibitors (eg, clopidogrel, ticlopidine), or salicylates (eg, aspirin) because they may increase the risk of bleeding

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fondaparinux may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fondaparinux:

Use Fondaparinux as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Fondaparinux. Talk to your pharmacist if you have questions about this information. Fondaparinux is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Fondaparinux at home, a health care provider will teach you how to use it. Be sure you understand how to use Fondaparinux. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. Do not use Fondaparinux if it contains particles, is cloudy or discolored, or if the syringe is cracked or damaged. Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle. Use a different injection site each day to prevent problems at the injection site (eg, hematomas). Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal. If you miss a dose of Fondaparinux, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Fondaparinux.

Important safety information: Fondaparinux may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools. Tell your doctor or dentist that you take Fondaparinux before you receive any medical or dental care, emergency care, or surgery. Before you begin taking any new prescription or nonprescription medicine, check the label to see if it has aspirin or ibuprofen in it. If it does or you are not sure, contact your doctor or pharmacist. Fondaparinux may affect certain lab tests, including liver enzyme. Be sure your doctor and lab personnel know you are using Fondaparinux. Lab tests, including complete blood cell counts (eg, platelet counts), kidney function, and stool blood, may be performed while you use Fondaparinux. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Fondaparinux with caution in the ELDERLY; they may be more sensitive to its effects, especially bleeding. Fondaparinux should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. Children may have an increased risk of bleeding with Fondaparinux. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fondaparinux while you are pregnant. It is not known if Fondaparinux is found in breast milk. If you are or will be breast-feeding while you use Fondaparinux, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Fondaparinux:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild bleeding, irritation, rash, or itching at the injection site; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody, black, tarry stools; confusion; difficulty walking; fainting; fever; increased drainage or oozing from a wound; loss of appetite; nosebleed; one-sided weakness; pale skin; pink or red urine; severe or persistent dizziness or headache; severe or persistent tiredness, weakness, nausea, or vomiting; slurred speech; swelling of the ankles, feet, or hands; tingling or numbness (especially in the legs and feet), and muscle weakness; unusual or severe bleeding or bruising; vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Fondaparinux side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include excessive bleeding and bruising.

Proper storage of Fondaparinux:

Store Fondaparinux at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Fondaparinux out of the reach of children and away from pets.

General information: If you have any questions about Fondaparinux, please talk with your doctor, pharmacist, or other health care provider. Fondaparinux is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Fondaparinux. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Fondaparinux resources Fondaparinux Side Effects (in more detail) Fondaparinux Use in Pregnancy & Breastfeeding Fondaparinux Drug Interactions Fondaparinux Support Group 3 Reviews for Fondaparinux - Add your own review/rating fondaparinux Concise Consumer Information (Cerner Multum) fondaparinux Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information Arixtra Prescribing Information (FDA) Arixtra Monograph (AHFS DI) Compare Fondaparinux with other medications Deep Vein Thrombosis Deep Vein Thrombosis Prophylaxis after Abdominal Surgery Deep Vein Thrombosis Prophylaxis after Hip Replacement Surgery Deep Vein Thrombosis Prophylaxis after Knee Replacement Surgery Deep Vein Thrombosis, Prophylaxis Pulmonary Embolism
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Tamoxifen


Pronunciation: ta-MOX-i-fen
Generic Name: Tamoxifen
Brand Name: Nolvadex

Women taking Tamoxifen to decrease the risk of developing breast cancer have developed cancer of the uterus, stroke, and blood clots in the lung. Some of these events have been fatal. Contact your doctor right away if you develop any of the following: unusual vaginal bleeding or discharge; abnormal menstrual period; groin pressure or pain; chest pain; shortness of breath; coughing up blood; confusion; one-sided weakness; vision or speech problems.

Women at high risk of breast cancer or with ductal carcinoma in situ (DCIS) should discuss the use of Tamoxifen with their doctor. Decide if the possible benefits (reducing the risk of breast cancer) outweigh the risk of these events. The benefits of Tamoxifen outweigh the risks in women who already have breast cancer.


Tamoxifen is used for:

Treating breast cancer that has spread to other sites in the body. It is also used along with other medicines to treat other types of breast cancer. It is used in women who are at high risk for breast cancer and in women with DCIS (after surgery and radiation) to decrease the risk of developing breast cancer. It may also be used for other conditions as determined by your doctor.

Tamoxifen is an antiestrogen. It works by blocking the effect of estrogen on certain tumors. This may prevent the growth of tumors that are activated by estrogen.

Do NOT use Tamoxifen if: you are allergic to any ingredient in Tamoxifen you are using Tamoxifen to reduce your risk of breast cancer and you have a history of blood clots in the lung or leg you are using Tamoxifen to reduce your risk of breast cancer and you also take certain anticoagulants (eg, warfarin) you are taking anastrozole

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tamoxifen:

Some medical conditions may interact with Tamoxifen. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of blood clots in the legs or lungs if you have high levels of calcium in your blood, a weakened immune system, or low levels of white blood cells or platelets in your blood if you have high cholesterol or lipid levels if you have cataracts or other vision problems if you are using cytotoxic cancer medicines if you are confined to a bed or chair

Some MEDICINES MAY INTERACT with Tamoxifen. Tell your health care provider if you are taking any other medicines, especially any of the following:

Anticoagulants (eg, warfarin) because the risk of bleeding may be increased Cytotoxic cancer medicines (eg, cisplatin) because the risk of developing blood clots may be increased Rifampin because it may decrease Tamoxifen's effectiveness Fluorouracil or mitomycin C because they may increase the risk of Tamoxifen's side effects Aromatase inhibitors (eg, anastrozole, letrozole) because their effectiveness may be decreased by Tamoxifen

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tamoxifen may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tamoxifen:

Use Tamoxifen as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Tamoxifen comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Tamoxifen refilled. Tamoxifen may be taken by mouth with or without food. Take Tamoxifen with water or another nonalcoholic liquid. Swallow this medication whole. Do not break, crush, or chew before swallowing. Continue to take Tamoxifen even if you feel well. Do not miss any doses. Taking Tamoxifen at the same time each day will help you to remember to take it. If you miss a dose of Tamoxifen, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tamoxifen.

Important safety information: Tamoxifen may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Tamoxifen with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Tamoxifen may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools. Tamoxifen may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills. New tumors have occurred in body sites other than the uterus in patients taking Tamoxifen. It is unknown if Tamoxifen may be the cause. Discuss any questions or concerns with your doctor. Women who take Tamoxifen to reduce the risk of breast cancer should have a breast exam, mammogram, and gynecological exam before starting and during treatment with Tamoxifen. Women who may become pregnant should begin taking Tamoxifen during a menstrual period. Women who have irregular menstrual periods should have a pregnancy test immediately before starting Tamoxifen. Talk to your doctor if you have any questions about how to begin taking Tamoxifen. Women who may become pregnant must use effective nonhormonal birth control (eg, condoms, diaphragm) during sexual intercourse while they are taking Tamoxifen and for 2 months after they stop taking it. Do not use hormonal birth control (eg, birth control pills); it may not work as well while you are taking Tamoxifen. Discuss any questions about effective nonhormonal birth control with your doctor. Tamoxifen will not prevent you from becoming pregnant. Lab tests, including breast exams, mammograms, gynecologic exams, complete blood counts, and liver function tests, may be performed while you use Tamoxifen. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Tamoxifen should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: Tamoxifen may cause harm to the fetus. Do not become pregnant while you are using it and for 2 months after you stop using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tamoxifen while you are pregnant. It is not known if Tamoxifen is found in breast milk. Do not breast-feed while taking Tamoxifen. Possible side effects of Tamoxifen:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bone pain; constipation; coughing; hot flashes; muscle pain; nausea; tiredness; vaginal discharge; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unexplained hoarseness); abnormal menstrual periods; abnormal vaginal bleeding or bloody discharge; chest pain; coughing up blood; dark urine; decreased sexual desire or ability; depression; fever, chills, or persistent sore throat; groin or pelvic pain or pressure; loss of appetite; loss of balance or coordination; missed menstrual period; new or increased breast tumor or pain; new or unusual lumps; one-sided weakness; pain or swelling in one or both legs; red, swollen, blistered, or peeling skin; severe or persistent tiredness or weakness; shortness of breath; skin changes; stomach pain; sudden severe headache; swelling of the arms or the legs; unusual bleeding or bruising; vision or speech problems; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Tamoxifen side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include exaggerated reflexes; seizures; severe or persistent dizziness; tremor; trouble breathing; trouble walking.

Proper storage of Tamoxifen:

Store Tamoxifen between 68 and 77 degrees F (20 and 25 degrees C) in a tightly closed, light-resistant container. Store away from moisture, heat, and light. Do not store in the bathroom. Do not take tablets after the expiration date printed on the label. Keep Tamoxifen out of the reach of children and away from pets.

General information: If you have any questions about Tamoxifen, please talk with your doctor, pharmacist, or other health care provider. Tamoxifen is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Tamoxifen. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Tamoxifen resources Tamoxifen Side Effects (in more detail) Tamoxifen Dosage Tamoxifen Use in Pregnancy & Breastfeeding Drug Images Tamoxifen Drug Interactions Tamoxifen Support Group 7 Reviews for Tamoxifen - Add your own review/rating Tamoxifen Prescribing Information (FDA) tamoxifen Advanced Consumer (Micromedex) - Includes Dosage Information tamoxifen Concise Consumer Information (Cerner Multum) Nolvadex Prescribing Information (FDA) Nolvadex Monograph (AHFS DI) Soltamox Prescribing Information (FDA) Compare Tamoxifen with other medications Breast Cancer Breast Cancer, Adjuvant Breast Cancer, Male Breast Cancer, Metastatic Breast Cancer, Palliative McCune-Albright Syndrome Precocious Puberty
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Lovenox


Pronunciation: ee-nox-AP-a-rin
Generic Name: Enoxaparin
Brand Name: Lovenox

Tell your doctor you use Lovenox before you have any type of spinal puncture or epidural/spinal anesthesia. Patients who have these procedures while they use Lovenox are at risk for developing a blood clot on or near the spinal cord. This could result in long-term or permanent paralysis.

The risk is increased in patients who have an indwelling epidural catheter, traumatic or repeated epidural or spinal puncture, history of a deformed spine or spinal surgery, and in patients who use medicines that may affect blood clotting such as warfarin, aspirin, platelet inhibitors (eg, clopidogrel), and nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen).

If you have a spinal puncture or epidural/spinal anesthesia while you use Lovenox, tell your doctor immediately if you notice any signs or symptoms of nerve problems, such as numbness or tingling, muscle weakness, or paralysis.


Lovenox is used for:

Preventing blood clots in patients who have certain illnesses or who will be having certain types of surgery. It is also used along with other medicine to treat blood clots. It is also used along with other medicine to prevent certain problems caused by heart attack or unstable angina (chest pain). It is also used to decrease the risk of recurring heart attack in certain patients. It may also be used for other conditions as determined by your doctor.

Lovenox is a low molecular weight heparin (LMWH). It works by blocking the formation of blood clots.

Do NOT use Lovenox if: you are allergic to any ingredient in Lovenox you are allergic to heparin, benzyl alcohol, or pork products you have severe or uncontrolled high blood pressure, or active major bleeding you are taking a salicylate (eg, aspirin) or an NSAID (eg, ibuprofen, naproxen) you have a low platelet count and the presence of antiplatelet antibodies

Contact your doctor or health care provider right away if any of these apply to you.

Before using Lovenox:

Some medical conditions may interact with Lovenox. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of kidney problems, liver problems, stomach or intestinal problems (eg, ulcers), stroke, or vision problems caused by diabetes if you have inflammation of the heart due to a bacterial infection; severe, uncontrolled high blood pressure; low body weight; or have a mechanical prosthetic heart valve if you have a bleeding disorder, a history of brain bleeding or blood conditions, or von Willebrand disease if you have recently had or are scheduled to have brain, spine, or eye surgery, an epidural catheter, or a spinal puncture if you are taking medicines that affect platelets (eg, aspirin, clopidogrel, ticlopidine) if you have a history of low platelet counts or bleeding problems after taking heparin if you have recently given birth

Some MEDICINES MAY INTERACT with Lovenox. Tell your health care provider if you are taking any other medicines, especially any of the following:

Activated protein C, anticoagulants (eg, warfarin), dextran, dipyridamole, direct factor XA inhibitors (eg, rivaroxaban), direct thrombin inhibitors (eg, dabigatran), injectable cephalosporins (eg, cephazolin), injectable penicillins (eg, ampicillin), NSAIDs (eg, ibuprofen, ketorolac, naproxen), platelet inhibitors (eg, clopidogrel, ticlopidine), salicylates (eg, aspirin), sulfinpyrazone, or thrombolytics (eg, streptokinase) because the risk of side effects, such as bleeding, may be increased Nitrates (eg, nitroglycerin) because they may decrease the effectiveness of Lovenox

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lovenox may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Lovenox:

Use Lovenox as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Lovenox is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Lovenox at home, a health care provider will teach you how to use it. Be sure you understand how to use Lovenox. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle. Do not use Lovenox if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal. If you miss a dose of Lovenox, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Lovenox.

Important safety information: Lovenox may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools. Tell your doctor or dentist that you take Lovenox before you receive any medical or dental care, emergency care, or surgery. Before you begin taking any new prescription or nonprescription medicine, check the label to see if it has aspirin or ibuprofen in it. If it does or you are not sure, contact your doctor or pharmacist. Some forms of Lovenox contain benzyl alcohol. Do not use medicine with benzyl alcohol in NEWBORNS or INFANTS. It may cause serious and sometimes fatal side effects. If you have questions, check with your doctor or pharmacist. If you have ever had an allergic reaction to benzyl alcohol, ask your doctor or pharmacist if your medicine has benzyl alcohol in it. Lovenox may affect certain lab tests, including liver enzyme. Be sure your doctor and lab personnel know you are using Lovenox. Lab tests, including complete blood cell counts (eg, platelet counts) and tests for blood in the stool, may be performed while you use Lovenox. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Lovenox with caution in the ELDERLY; they may be more sensitive to its effects, especially bleeding. Lovenox should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: Lovenox may contain the preservative benzyl alcohol, which can cause harm to the fetus. If you become pregnant, use a formulation without this preservative. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Lovenox while you are pregnant. It is not known if Lovenox is found in breast milk. If you are or will be breast-feeding while you are using Lovenox, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Lovenox:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; mild pain, irritation, swelling, redness, bleeding, or bruising at the injection site; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody, black, or tarry stools; confusion; difficulty walking; fainting; fever; pale skin; pink or red urine; severe or persistent dizziness, tiredness, or weakness; swelling; tingling, numbness (especially in the legs and feet), and muscle weakness; unusual bleeding or bruising; vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Lovenox side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bruising; excessive bleeding.

Proper storage of Lovenox:

Store Lovenox at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Lovenox out of the reach of children and away from pets.

General information: If you have any questions about Lovenox, please talk with your doctor, pharmacist, or other health care provider. Lovenox is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Lovenox. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Lovenox resources Lovenox Side Effects (in more detail) Lovenox Use in Pregnancy & Breastfeeding Drug Images Lovenox Drug Interactions Lovenox Support Group 8 Reviews for Lovenox - Add your own review/rating Lovenox Prescribing Information (FDA) Lovenox Monograph (AHFS DI) Lovenox Advanced Consumer (Micromedex) - Includes Dosage Information Lovenox Consumer Overview Compare Lovenox with other medications Acute Coronary Syndrome Angina Deep Vein Thrombosis Deep Vein Thrombosis Prophylaxis after Abdominal Surgery Deep Vein Thrombosis Prophylaxis after Hip Replacement Surgery Deep Vein Thrombosis Prophylaxis after Knee Replacement Surgery Deep Vein Thrombosis, Prophylaxis Heart Attack
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GLIVEC Tablets


1. Name Of The Medicinal Product

Glivec® 100 mg film-coated tablets

Glivec® 400 mg film-coated tablets

2. Qualitative And Quantitative Composition

Glivec 100 mg film-coated tablets: Each film-coated tablet contains 100 mg imatinib (as mesilate).

Glivec 400 mg film-coated tablets: Each film-coated tablet contains 400 mg imatinib (as mesilate).

For the full list of excipients, see section 6.1.

3. Pharmaceutical Form

Glivec 100 mg film-coated tablets: Very dark yellow to brownish-orange film-coated tablet, round with “NVR” on one side and “SA” and score on the other side.

Glivec 400 mg film-coated tablets: Very dark yellow to brownish-orange, ovaloid, biconvex film-coated tablet with bevelled edges, debossed with “NVR” on one side and “SL” on the other side.

4. Clinical Particulars 4.1 Therapeutic Indications

Glivec is indicated for the treatment of

• adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment.

• adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.

• adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.

• adult patients with relapsed or refractory Ph+ ALL as monotherapy.

• adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.

• adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR? rearrangement.

The effect of Glivec on the outcome of bone marrow transplantation has not been determined.

Glivec is indicated for

• the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).

• the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment.

• The treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.

In adult and paediatric patients, the effectiveness of Glivec is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic GIST and DFSP and on recurrence-free survival in adjuvant GIST. The experience with Glivec in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1). Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.

4.2 Posology And Method Of Administration

Therapy should be initiated by a physician experienced in the treatment of patients with haematological malignancies and malignant sarcomas, as appropriate.

For doses of 400 mg and above (see dosage recommendation below) a 400 mg tablet (not divisible) is available.

For doses other than 400 mg and 800 mg (see dosage recommendation below) a 100 mg divisible tablet is available.

The prescribed dose should be administered orally with a meal and a large glass of water to minimise the risk of gastrointestinal irritations. Doses of 400 mg or 600 mg should be administered once daily, whereas a daily dose of 800 mg should be administered as 400 mg twice a day, in the morning and in the evening.

For patients unable to swallow the film-coated tablets, the tablets may be dispersed in a glass of mineral water or apple juice. The required number of tablets should be placed in the appropriate volume of beverage (approximately 50 ml for a 100 mg tablet, and 200 ml for a 400 mg tablet) and stirred with a spoon. The suspension should be administered immediately after complete disintegration of the tablet(s).

Posology for CML in adult patients

The recommended dosage of Glivec is 400 mg/day for adult patients in chronic phase CML. Chronic phase CML is defined when all of the following criteria are met: blasts < 15% in blood and bone marrow, peripheral blood basophils < 20%, platelets > 100 x 109/l.

The recommended dosage of Glivec is 600 mg/day for adult patients in accelerated phase. Accelerated phase is defined by the presence of any of the following: blasts 9/l unrelated to therapy.

The recommended dose of Glivec is 600 mg/day for adult patients in blast crisis. Blast crisis is defined as blasts

Treatment duration: In clinical trials, treatment with Glivec was continued until disease progression. The effect of stopping treatment after the achievement of a complete cytogenetic response has not been investigated.

Dose increases from 400 mg to 600 mg or 800 mg in patients with chronic phase disease, or from 600 mg to a maximum of 800 mg (given as 400 mg twice daily) in patients with accelerated phase or blast crisis may be considered in the absence of severe adverse drug reaction and severe non-leukaemia-related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response. Patients should be monitored closely following dose escalation given the potential for an increased incidence of adverse reactions at higher dosages.

Posology for CML in children

Dosing for children should be on the basis of body surface area (mg/m2). The doses of 340 mg/m2 daily is recommended for children with chronic phase CML and advanced phase CML (not to exceed the total dose of 800 mg). Treatment can be given as a once daily dose or alternatively the daily dose may be split into two administrations - one in the morning and one in the evening. The dose recommendation is currently based on a small number of paediatric patients (see sections 5.1 and 5.2). There is no experience with the treatment of children below 2 years of age.

Dose increases from 340 mg/m2 daily to 570 mg/m2 daily (not to exceed the total dose of 800 mg) may be considered in children in the absence of severe adverse drug reaction and severe non-leukaemia-related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response. Patients should be monitored closely following dose escalation given the potential for an increased incidence of adverse reactions at higher dosages.

Posology for Ph+ ALL

The recommended dose of Glivec is 600 mg/day for adult patients with Ph+ ALL. Haematological experts in the management of this disease should supervise the therapy throughout all phases of care.

Treatment schedule: On the basis of the existing data, Glivec has been shown to be effective and safe when administered at 600 mg/day in combination with chemotherapy in the induction phase, the consolidation and maintenance phases of chemotherapy (see section 5.1) for adult patients with newly diagnosed Ph+ ALL. The duration of Glivec therapy can vary with the treatment programme selected, but generally longer exposures to Glivec have yielded better results.

For adult patients with relapsed or refractory Ph+ALL Glivec monotherapy at 600 mg/day is safe, effective and can be given until disease progression occurs.

Posology for MDS/MPD

The recommended dose of Glivec is 400 mg/day for adult patients with MDS/MPD.

Treatment duration: In the only clinical trial performed up to now, treatment with Glivec was continued until disease progression (see section 5.1). At the time of analysis, the treatment duration was a median of 47 months (24 days - 60 months).

Posology for HES/CEL

The recommended dose of Glivec is 100 mg/day for adult patients with HES/CEL.

Dose increase from 100 mg to 400 mg may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy.

Treatment should be continued as long as the patient continues to benefit.

Posology for GIST

The recommended dose of Glivec is 400 mg/day for adult patients with unresectable and/or metastatic malignant GIST.

Limited data exist on the effect of dose increases from 400 mg to 600 mg or 800 mg in patients progressing at the lower dose (see section 5.1).

Treatment duration: In clinical trials in GIST patients, treatment with Glivec was continued until disease progression. At the time of analysis, the treatment duration was a median of 7 months (7 days to 13 months). The effect of stopping treatment after achieving a response has not been investigated.

The recommended dose of Glivec is 400 mg/day for the adjuvant treatment of adult patients following resection of GIST. Optimal treatment duration is not yet established. Length of treatment in the clinical trial supporting this indication was 12 months.

Posology for DFSP

The recommended dose of Glivec is 800 mg/day for adult patients with DFSP.

Dose adjustment for adverse reactions

Non-haematological adverse reactions

If a severe non-haematological adverse reaction develops with Glivec use, treatment must be withheld until the event has resolved. Thereafter, treatment can be resumed as appropriate depending on the initial severity of the event.

If elevations in bilirubin > 3 x institutional upper limit of normal (IULN) or in liver transaminases > 5 x IULN occur, Glivec should be withheld until bilirubin levels have returned to < 1.5 x IULN and transaminase levels to < 2.5 x IULN. Treatment with Glivec may then be continued at a reduced daily dose. In adults the dose should be reduced from 400 to 300 mg or from 600 to 400 mg, or from 800 mg to 600 mg, and in children from 340 to 260 mg/m2/day.

Haematological adverse reactions

Dose reduction or treatment interruption for severe neutropenia and thrombocytopenia are recommended as indicated in the table below.

Dose adjustments for neutropenia and thrombocytopenia:

HES/CEL (starting dose 100 mg)

ANC < 1.0 x 109/l

and/or

platelets < 50 x 109/l

1. Stop Glivec until ANC 9/l and platelets 9/l.

2. Resume treatment with Glivec at previous dose (i.e. before severe adverse reaction).

Chronic phase CML, MDS/MPD and GIST (starting dose 400 mg) HES/CEL (at dose 400 mg)

ANC < 1.0 x 109/l

and/or

platelets < 50 x 109/l

1. Stop Glivec until ANC 9/l and platelets 9/l.

2. Resume treatment with Glivec at previous dose (i.e. before severe adverse reaction).

3. In the event of recurrence of ANC < 1.0 x 109/l and/or platelets < 50 x 109/l, repeat step 1 and resume Glivec at reduced dose of 300 mg.

Paediatric chronic phase CML

(at dose 340 mg/m2)

ANC < 1.0 x 109/l

and/or

platelets < 50 x 109/l

 

1. Stop Glivec until ANC 9/l and platelets 9/l.

2. Resume treatment with Glivec at previous dose (i.e. before severe adverse reaction).

3. In the event of recurrence of ANC < 1.0 x109/l and/or platelets < 50 x109/l, repeat step 1 and resume Glivec at reduced dose of 260 mg/m2.

Accelerated phase CML and blast crisis and Ph+ ALL (starting dose 600 mg)

aANC < 0.5 x 109/l

and/or

platelets < 10 x 109/l

1. Check whether cytopenia is related to leukaemia (marrow aspirate or biopsy).

2. If cytopenia is unrelated to leukaemia, reduce dose of Glivec to 400 mg.

3. If cytopenia persists for 2 weeks, reduce further to 300 mg.

4. If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop Glivec until ANC 9/l and platelets 9/l, then resume treatment at 300 mg.

Paediatric accelerated phase CML and blast crisis (starting dose 340 mg/m2)

aANC < 0.5 x 109/l

and/or

platelets < 10 x 109/l

1. Check whether cytopenia is related to leukaemia (marrow aspirate or biopsy).

2. If cytopenia is unrelated to leukaemia, reduce dose of Glivec to 260 mg/m2.

3. If cytopenia persists for 2 weeks, reduce further to 200 mg/m2.

4. If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop Glivec until ANC 9/l and platelets 9/l, then resume treatment at 200 mg/m2.

DFSP

(at dose 800 mg)

ANC < 1.0 x 109/l

and/or

platelets < 50 x 109/l

1. Stop Glivec until ANC 9/l and platelets 9/l.

2. Resume treatment with Glivec at 600 mg.

3. In the event of recurrence of ANC < 1.0 x 109/l and/or platelets < 50 x 109/l, repeat step 1 and resume Glivec at reduced dose of 400 mg.

ANC = absolute neutrophil count

   

a occurring after at least 1 month of treatment

   

Special populations

Paediatric use: There is no experience in children with CML below 2 years of age (see section 5.1). There is limited experience in children with Ph+ ALL and very limited experience in children with MDS/MPD and DFSP. There is no experience in children or adolescents with GIST and HES/CEL.

Hepatic insufficiency: Imatinib is mainly metabolised through the liver. Patients with mild, moderate or severe liver dysfunction should be given the minimum recommended dose of 400 mg daily. The dose can be reduced if not tolerated (see sections 4.4, 4.8 and 5.2).

Liver dysfunction classification:

Liver dysfunction

Liver function tests

Mild

Total bilirubin: = 1.5 ULN

AST: >ULN (can be normal or <ULN if total bilirubin is >ULN)

Moderate

Total bilirubin: >1.5-3.0 ULN

AST: any

Severe

Total bilirubin: >3-10 ULN

AST: any

ULN = upper limit of normal for the institution

AST = aspartate aminotransferase

Renal insufficiency: Patients with renal dysfunction or on dialysis should be given the minimum recommended dose of 400 mg daily as starting dose. However, in these patients caution is recommended. The dose can be reduced if not tolerated. If tolerated, the dose can be increased for lack of efficacy (see sections 4.4 and 5.2).

Elderly patients: Imatinib pharmacokinetics have not been specifically studied in the elderly. No significant age-related pharmacokinetic differences have been observed in adult patients in clinical trials which included over 20% of patients age 65 and older. No specific dose recommendation is necessary in the elderly.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special Warnings And Precautions For Use

When Glivec is co-administered with other medicinal products, there is a potential for drug interactions. Caution should be used when taking Glivec with ketoconazole or other strong CYP3A4 inhibitors, CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporin or pimozide) or CYP2C9 substrates with a narrow therapeutic window (e.g. warfarin and other coumarin derivatives) (see section 4.5).

Concomitant use of imatinib and medicinal products that induce CYP3A4 (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital or Hypericum perforatum, also known as St. John's Wort) may significantly reduce exposure to Glivec, potentially increasing the risk of therapeutic failure. Therefore, concomitant use of strong CYP3A4 inducers and imatinib should be avoided (see section 4.5).

Hypothyroidism

Clinical cases of hypothyroidism have been reported in thyroidectomy patients undergoing levothyroxine replacement during treatment with Glivec (see section 4.5). Thyroid-stimulating hormone (TSH) levels should be closely monitored in such patients.

Hepatotoxicity

Metabolism of Glivec is mainly hepatic, and only 13% of excretion is through the kidneys. In patients with hepatic dysfunction (mild, moderate or severe), peripheral blood counts and liver enzymes should be carefully monitored (see sections 4.2, 4.8 and 5.2). It should be noted that GIST patients may have hepatic metastases which could lead to hepatic impairment.

Cases of liver injury, including hepatic failure and hepatic necrosis, have been observed with imatinib. When imatinib is combined with high dose chemotherapy regimens, an increase in serious hepatic reactions has been detected. Hepatic function should be carefully monitored in circumstances where imatinib is combined with chemotherapy regimens also known to be associated with hepatic dysfunction (see section 4.5 and 4.8).

Fluid retention

Occurrences of severe fluid retention (pleural effusion, oedema, pulmonary oedema, ascites, superficial oedema) have been reported in approximately 2.5% of newly diagnosed CML patients taking Glivec. Therefore, it is highly recommended that patients be weighed regularly. An unexpected rapid weight gain should be carefully investigated and if necessary appropriate supportive care and therapeutic measures should be undertaken. In clinical trials, there was an increased incidence of these events in elderly patients and those with a prior history of cardiac disease. Therefore, caution should be exercised in patients with cardiac dysfunction.

Patients with cardiac disease

Patients with cardiac disease, risk factors for cardiac failure or history of renal failure should be monitored carefully, and any patient with signs or symptoms consistent with cardiac or renal failure should be evaluated and treated.

In patients with hypereosinophilic syndrome (HES) and cardiac involvement, isolated cases of cardiogenic shock/left ventricular dysfunction have been associated with the initiation of imatinib therapy. The condition was reported to be reversible with the administration of systemic steroids, circulatory support measures and temporarily withholding imatinib. As cardiac adverse events have been reported uncommonly with imatinib, a careful assessment of the benefit/risk of imatinib therapy should be considered in the HES/CEL population before treatment initiation. Myelodysplastic/myeloproliferative diseases with PDGFR gene re-arrangements could be associated with high eosinophil levels. Evaluation by a cardiology specialist, performance of an echocardiogram and determination of serum troponin should therefore be considered in patients with HES/CEL, and in patients with MDS/MPD associated with high eosinophil levels before imatinib is administered. If either is abnormal, follow-up with a cardiology specialist and the prophylactic use of systemic steroids (1-2 mg/kg) for one to two weeks concomitantly with imatinib should be considered at the initiation of therapy.

Gastrointestinal haemorrhage

In the study in patients with unresectable and/or metastatic GIST, both gastrointestinal and intra-tumoural haemorrhages were reported (see section 4.8). Based on the available data, no predisposing factors (e.g. tumour size, tumour location, coagulation disorders) have been identified that place patients with GIST at a higher risk of either type of haemorrhage. Since increased vascularity and propensity for bleeding is a part of the nature and clinical course of GIST, standard practices and procedures for the monitoring and management of haemorrhage in all patients should be applied.

Tumor lysis syndrome

Due to the possible occurrence of tumour lysis syndrome (TLS), correction of clinically significant dehydration and treatment of high uric acid levels are recommended prior to initiation of Glivec (see section 4.8).

Laboratory tests

Complete blood counts must be performed regularly during therapy with Glivec. Treatment of CML patients with Glivec has been associated with neutropenia or thrombocytopenia. However, the occurrence of these cytopenias is likely to be related to the stage of the disease being treated and they were more frequent in patients with accelerated phase CML or blast crisis as compared to patients with chronic phase CML. Treatment with Glivec may be interrupted or the dose may be reduced, as recommended in section 4.2.

Liver function (transaminases, bilirubin, alkaline phosphatase) should be monitored regularly in patients receiving Glivec.

In patients with impaired renal function, imatinib plasma exposure seems to be higher than that in patients with normal renal function, probably due to an elevated plasma level of alpha-acid glycoprotein (AGP), an imatinib-binding protein, in these patients. Patients with renal impairment should be given the minimum starting dose. Patients with severe renal impairment should be treated with caution. The dose can be reduced if not tolerated (see section 4.2 and 5.2).

Paediatric population

There have been case reports of growth retardation occurring in children and pre-adolescents receiving imatinib. The long-term effects of prolonged treatment with imatinib on growth in children are unknown. Therefore, close monitoring of growth in children under imatinib treatment is recommended (see section 4.8).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Active substances that may increase imatinib plasma concentrations:

Substances that inhibit the cytochrome P450 isoenzyme CYP3A4 activity (e.g. ketoconazole, itraconazole, erythromycin, clarithromycin) could decrease metabolism and increase imatinib concentrations. There was a significant increase in exposure to imatinib (the mean Cmax and AUC of imatinib rose by 26% and 40%, respectively) in healthy subjects when it was co-administered with a single dose of ketoconazole (a CYP3A4 inhibitor). Caution should be taken when administering Glivec with inhibitors of the CYP3A4 family.

Active substances that may decrease imatinib plasma concentrations:

Substances that are inducers of CYP3A4 activity (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, fosphenytoin, primidone or Hypericum perforatum, also known as St. John's Wort) may significantly reduce exposure to Glivec, potentially increasing the risk of therapeutic failure. Pretreatment with multiple doses of rifampicin 600 mg followed by a single 400 mg dose of Glivec resulted in decrease in Cmax and AUC(0- by at least 54% and 74%, of the respective values without rifampicin treatment. Similar results were observed in patients with malignant gliomas treated with Glivec while taking enzyme-inducing anti-epileptic drugs (EIAEDs) such as carbazepine, oxcarbazepine and phenytoin. The plasma AUC for imatinib decreased by 73% compared to patients not on EIAEDs. Concomitant use of rifampicin or other strong CYP3A4 inducers and imatinib should be avoided.

Active substances that may have their plasma concentration altered by Glivec

Imatinib increases the mean Cmax and AUC of simvastatin (CYP3A4 substrate) 2- and 3.5-fold, respectively, indicating an inhibition of the CYP3A4 by imatinib. Therefore, caution is recommended when administering Glivec with CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporin or pimozide). Glivec may increase plasma concentration of other CYP3A4 metabolised drugs (e.g. triazolo-benzodiazepines, dihydropyridine calcium channel blockers, certain HMG-CoA reductase inhibitors, i.e. statins, etc.).

Because warfarin is metabolised by CYP2C9, patients who require anticoagulation should receive low-molecular-weight or standard heparin.

In vitro Glivec inhibits the cytochrome P450 isoenzyme CYP2D6 activity at concentrations similar to those that affect CYP3A4 activity. Imatinib at 400 mg twice daily had an inhibitory effect on CYP2D6-mediated metoprolol metabolism, with metoprolol Cmax and AUC being increased by approximately 23% (90%CI [1.16-1.30]). Dose adjustments do not seem to be necessary when imatinib is co-administrated with CYP2D6 substrates, however caution is advised for CYP2D6 substrates with a narrow therapeutic window such as metoprolol. In patients treated with metoprolol clinical monitoring should be considered.

In vitro, Glivec inhibits paracetamol O-glucuronidation with Ki value of 58.5 micromol/l. This inhibition has not been observed in vivo after the administration of Glivec 400 mg and paracetamol 1000 mg. Higher doses of Glivec and paracetamol have not been studied.

Caution should therefore be exercised when using high doses of Glivec and paracetamol concomitantly.

In thyroidectomy patients receiving levothyroxine, the plasma exposure to levothyroxine may be decreased when Glivec is co-administered (see section 4.4). Caution is therefore recommended. However, the mechanism of the observed interaction is presently unknown.

In Ph+ ALL patients, there is clinical experience of co-administering Glivec with chemotherapy (see section 5.1), but drug-drug interactions between imatinib and chemotherapy regimens are not well characterised. Imatinib adverse events, i.e. hepatotoxicity, myelosuppression or others, may increase and it has been reported that concomitant use with L-asparaginase could be associated with increased hepatotoxicity (see section 4.8). Therefore, the use of Glivec in combination requires special precaution.

4.6 Pregnancy And Lactation

Pregnancy

There are limited data on the use of imatinib in pregnant women. Studies in animals have however shown reproductive toxicity (see section 5.3) and the potential risk for the foetus is unknown. Glivec should not be used during pregnancy unless clearly necessary. If it is used during pregnancy, the patient must be informed of the potential risk to the foetus.

Women of childbearing potential must be advised to use effective contraception during treatment.

Breast-feeding

There is limited information on imatinib distribution on human milk. Studies in two breast-feeding women revealed that both imatinib and its active metabolite can be distributed into human milk. The milk plasma ratio studied in a single patient was determined to be 0.5 for imatinib and 0.9 for the metabolite, suggesting greater distribution of the metabolite into the milk. Considering the combined concentration of imatinib and the metabolite and the maximum daily milk intake by infants, the total exposure would be expected to be low (~10% of a therapeutic dose). However, since the effects of low-dose exposure of the infant to imatinib are unknown, women taking imatinib should not breast-feed.

Fertility

In non-clinical studies, the fertility of male and female rats was not affected (see section 5.3). Studies on patients receiving Glivec and its effect on fertility and gametogenesis have not been performed. Patients concerned about their fertility on Glivec treatment should consult with their physician.

4.7 Effects On Ability To Drive And Use Machines

Patients should be advised that they may experience undesirable effects such as dizziness, blurred vision or somnolence during treatment with imatinib. Therefore, caution should be recommended when driving a car or operating machinery.

4.8 Undesirable Effects

Patients with advanced stages of malignancies may have numerous confounding medical conditions that make causality of adverse reactions difficult to assess due to the variety of symptoms related to the underlying disease, its progression, and the co-administration of numerous medicinal products.

In clinical trials in CML, drug discontinuation for drug-related adverse reactions was observed in 2.4% of newly diagnosed patients, 4% of patients in late chronic phase after failure of interferon therapy, 4% of patients in accelerated phase after failure of interferon therapy and 5% of blast crisis patients after failure of interferon therapy. In GIST the study drug was discontinued for drug-related adverse reactions in 4% of patients.

The adverse reactions were similar in all indications, with two exceptions. There was more myelosuppression seen in CML patients than in GIST, which is probably due to the underlying disease. In the study in patients with unresectable and/or metastatic GIST, 7 (5%) patients experienced CTC grade 3/4 GI bleeds (3 patients), intra-tumoural bleeds (3 patients) or both (1 patient). GI tumour sites may have been the source of the GI bleeds (see section 4.4). GI and tumoural bleeding may be serious and sometimes fatal. The most commonly reported (

When imatinib was combined with high dose chemotherapy in Ph+ ALL patients, transient liver toxicity in the form of transaminase elevation and hyperbilirubinaemia were observed.

Miscellaneous adverse reactions such as pleural effusion, ascites, pulmonary oedema and rapid weight gain with or without superficial oedema may be collectively described as “fluid retention”. These reactions can usually be managed by withholding Glivec temporarily and with diuretics and other appropriate supportive care measures. However, some of these reactions may be serious or life-threatening and several patients with blast crisis died with a complex clinical history of pleural effusion, congestive heart failure and renal failure. There were no special safety findings in paediatric clinical trials.

Adverse reactions

Adverse reactions reported as more than an isolated case are listed below, by system organ class and by frequency. Frequency categories are defined using the following convention: very common (

Within each frequency grouping, undesirable effects are presented in order of frequency, the most frequent first.

Adverse reactions and their frequencies reported in Table 1 are based on the main registration studies.

Table 1 Adverse reactions in clinical studies

Infections and infestations

 

Uncommon:

Herpes zoster, herpes simplex, nasopharyngitis, pneumonia1, sinusitis, cellulitis, upper respiratory tract infection, influenza, urinary tract infection, gastroenteritis, sepsis

Rare:

Fungal infection

Neoplasm benign, malignant and unspecified (including cysts and polyps)

 

Rare:

Tumour lysis syndrome

Blood and lymphatic system disorders

 

Very common:

Neutropenia, thrombocytopenia, anaemia

Common:

Pancytopenia, febrile neutropenia

Uncommon:

Thrombocythaemia, lymphopenia, bone marrow depression, eosinophilia, lymphadenopathy

Rare:

Haemolytic anaemia

Metabolism and nutrition disorders

 

Common:

Anorexia

Uncommon:

Hypokalaemia, increased appetite, hypophosphataemia, decreased appetite, dehydration, gout, hyperuricaemia, hypercalcaemia, hyperglycaemia, hyponatraemia

Rare:

Hyperkalaemia, hypomagnesaemia

Psychiatric disorders

 

Common:

Insomnia

Uncommon:

Depression, libido decreased, anxiety

Rare:

Confusional state

Nervous system disorders

 

Very common:

Headache2

Common:

Dizziness, paraesthesia, taste disturbance, hypoaesthesia

Uncommon:

Migraine, somnolence, syncope, peripheral neuropathy, memory impairment, sciatica, restless leg syndrome, tremor, cerebral haemorrhage

Rare:

Increased intracranial pressure, convulsions, optic neuritis

Eye disorders

 

Common:

Eyelid oedema, lacrimation increased, conjunctival haemorrhage, conjunctivitis, dry eye, blurred vision

Uncommon:

Eye irritation, eye pain, orbital oedema, scleral haemorrhage, retinal haemorrhage, blepharitis, macular oedema

Rare:

Cataract, glaucoma, papilloedema

Ear and labyrinth disorders

 

Uncommon:

Vertigo, tinnitus, hearing loss

Cardiac disorders

 

Uncommon:

Palpitations, tachycardia, cardiac failure congestive3, pulmonary oedema

Rare:

Arrhythmia, atrial fibrillation, cardiac arrest, myocardial infarction, angina pectoris, pericardial effusion

Vascular disorders4

 

Common:

Flushing, haemorrhage

Uncommon:

Hypertension, haematoma, peripheral coldness, hypotension, Raynaud's phenomenon

Respiratory, thoracic and mediastinal disorders

 

Common:

Dyspnoea, epistaxis, cough

Uncommon:

Pleural effusion5, pharyngolaryngeal pain, pharyngitis

Rare:

Pleuritic pain, pulmonary fibrosis, pulmonary hypertension, pulmonary haemorrhage

Gastrointestinal disorders

 

Very common:

Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain6

Common:

Flatulence, abdominal distension, gastro-oesophageal reflux, constipation, dry mouth, gastritis

Uncommon:

Stomatitis, mouth ulceration, gastrointestinal haemorrhage7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, dysphagia, pancreatitis

Rare:

Colitis, ileus, inflammatory bowel disease

Hepatobiliary disorders

 

Common:

Increased hepatic enzymes


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Refolinon Tablets


Refolinon 15 mg tablets

Leucovorin calcium

Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1.What Refolinon is and what it is used for 2.Before you take Refolinon 3.How to take Refolinon 4.Possible side effects 5.How to store Refolinon 6.Further information What Refolinon is and what it is used for

Refolinon contains leucovorin calcium which is chemically related to a vitamin called folic acid. Refolinon increases the levels of a folic acid in your body.

Methotrexate (a medicine used to treat cancer) can lower your body’s levels of folic acid. Refolinon is used to reverse this and help to maintain folic acid levels. This is known as ‘leucovorin rescue’.

Refolinon is also used to treat a form of anaemia (megaloblastic) which results from low levels of folic acid.

You should ask your doctor if you are unsure why you have been given Refolinon.

Before you take Refolinon Do not take Refolinon if: you are allergic (hypersensitive) to leucovorin calcium or any of the other ingredients of Refolinon. Take special care with Refolinon Tell your doctor before taking Refolinon if you currently have, or have had anaemia that needed treatment. Taking other medicines

Some medicines can affect the way Refolinon works, or Refolinon itself can reduce the effectiveness of other medicines taken at the same time.

The effectiveness of Refolinon can be reduced by chloramphenicol (an antibiotic). Refolinon can reduce the effectiveness of drugs used to treat epilepsy (phenobarbital, phenytoin or primidone) and lead to more frequent seizures (fits). Refolinon may increase the side effects of fluorouracil (used to treat cancer).

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and Breast-feeding

If you are pregnant, planning to get pregnant or are breast-feeding, tell your doctor before you take Refolinon.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Refolinon is not expected to affect your ability to drive or use machines.

Important information about some of the ingredients of Refolinon

Refolinon contains lactose, a type of sugar. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How to take Refolinon

Always take Refolinon exactly as you doctor has told you. You should check with your doctor or pharmacist if you are still not sure.

The usual dose in adults and children is as follows:

Refolinon for Leucovorin rescue: 15mg (1 tablet) every 6 hours for 48 hours

Refolinon for Megaloblastic anaemia: 15mg (1 tablet) daily until your doctor tells you to stop.

The tablets should be swallowed with a glass of water.

It is important to take your medicine at the right times. Refolinon for Leucovorin rescue therapy is usually started 24 hours after the start of methotrexate treatment. If you take more Refolinon than you should

If you accidentally take too much Refolinon contact your doctor. Side-effects with Refolinon are rare, since it is similar to a naturally occurring vitamin.

If you forget to take Refolinon

If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. Do not take a double dose to make up for a missed dose.

If you stop taking Refolinon

Do not stop taking Refolinon unless your doctor tells you to. If you suddenly stop taking this medicine your condition may return.

If you have any further questions on how to take this product, ask your doctor or pharmacist.

Refolinon Tablets Side Effects

Like all medicines, Refolinon can cause side effects, although not everybody gets them.

Tell your doctor immediately if you experience any of the following symptoms after taking this medicine. Although they are very rare, these symptoms can be serious.

sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body). If Refolinon is given with another drug called fluorouracil (to treat cancer) the following side effects have been reported: decreased white blood cell count or low platelets in the blood. Symptoms may include.bruising, nose bleeds or rash. Your doctor will take regular blood tests to check these. sore and inflamed mouth (stomatitis) and/or diarrhoea.

If you have received Refolinon by injection, prior to receiving the tablets, you can also get a high temperature.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Refolinon

Keep your tablets out of the reach and sight of children.

Do not use Refolinon after the expiry date which is stamped on the pack after EXP. The expiry date refers to the last day of that month.

Store your Refolinon Tablets below 25 °C. Do not refrigerate or freeze them.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information What Refolinon contains

The active substance in Refolinon tablets is 15mg of leucovorin (folinic acid) as the calcium salt.

The other ingredients are: Avicel PH101, magnesium stearate and lactose.

What Refolinon looks like and contents of the pack

Refolinon tablets are yellow in colour and are scored and marked CF on one side

The tablets are supplied in plastic containers of 30 or 100 tablets.

Marketing Authorisation Holder Pharmacia Limited Ramsgate Road Sandwich Kent CT13 9NJ Manufacturer: Orion Corporation PO Box 425 SF20101 Turku Finland

This leaflet was revised in May 2008

Ref: REB4_0


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