Mestinon Timespan
 

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Myasthenia Gravis Medications


Definition of Myasthenia Gravis: Myasthenia gravis is a neuromuscular disorder characterized by variable weakness of voluntary muscles, which often improves with rest and worsens with activity. The condition is caused by an abnormal immune response.

Drugs associated with Myasthenia Gravis

The following drugs and medications are in some way related to, or used in the treatment of Myasthenia Gravis. 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 Myasthenia Gravis

Micromedex Care Notes:

Myasthenia Gravis

Medical Encyclopedia:

Myasthenia gravis

Harvard Health Guide:

Symptoms and treatment for Myasthenia Gravis
Drug List: Mestinon Mestinon-Timespan Mytelase Mytelase-Chloride Prostigmin Prostigmin-Bromide Regonol Soliris


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Mestinon Timespan


Generic Name: pyridostigmine (py rid o STIG meen)
Brand Names: Mestinon, Mestinon Timespan

What is Mestinon Timespan (pyridostigmine)?

Pyridostigmine affects chemicals in the body that are involved in the communication between nerve impulses and muscle movement.

Pyridostigmine is used to treat the symptoms of myasthenia gravis. It is also used in military personnel who have been exposed to nerve gas.

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

What is the most important information I should know about Mestinon Timespan (pyridostigmine)? You should not use pyridostigmine if you are allergic to it, or if you have a bladder or bowel obstruction.

Before taking pyridostigmine, tell your doctor if you have asthma, kidney disease, an ulcer or other serious stomach disorder, high blood pressure, heart disease, overactive thyroid, or a history of seizures.

The amount and timing of this medicine is extremely important to the success of your treatment. Carefully follow your doctor's instructions about how much medicine to take and when to take it.

This medication may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Your doctor may occasionally change your dose to make sure you get the best results. You may be asked to keep a daily record of when you took each dose and how long the effects lasted. This will help your doctor determine if your dose needs to be adjusted.

If you need surgery, tell the surgeon ahead of time that you are using pyridostigmine. You may need to stop using the medicine for a short time. What should I discuss with my health care provider before taking Mestinon Timespan (pyridostigmine)? You should not use pyridostigmine if you are allergic to it, or if you have a bladder or bowel obstruction.

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

asthma;

kidney disease;

an ulcer or other serious stomach disorder;

high blood pressure, heart disease;

overactive thyroid; or

a history of seizures.

It is not known whether pyridostigmine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether pyridostigmine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take Mestinon Timespan (pyridostigmine)?

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.

Take this medicine with food or milk if it upsets your stomach. Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

Measure liquid medicine with a special dose measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose measuring device, ask your pharmacist for one.

The amount and timing of this medicine is extremely important to the success of your treatment. Carefully follow your doctor's instructions about how much medicine to take and when to take it.

Your doctor may occasionally change your dose to make sure you get the best results. You may be asked to keep a daily record of when you took each dose and how long the effects lasted. This will help your doctor determine if your dose needs to be adjusted.

If you need surgery, tell the surgeon ahead of time that you are using pyridostigmine. You may need to stop using the medicine for a short time. Store at room temperature away from moisture and heat.

Keep the tablets in their original container, along with the canister of moisture-absorbing preservative that comes with this medicine.

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 nausea, vomiting, diarrhea, stomach cramps, sweating, blurred vision, drooling, and weak or shallow breathing.

Worsening muscle weakness, or no change in your myasthenia gravis symptoms, may also be signs of overdose.

What should I avoid while taking Mestinon Timespan (pyridostigmine)? This medication may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Drinking alcohol can increase certain side effects of pyridostigmine. Mestinon Timespan (pyridostigmine) 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. Stop using pyridostigmine and call your doctor at once if you have any of these serious side effects:

extreme muscle weakness, muscle twicthing;

slurred speech, vision problems;

severe vomiting or diarrhea;

cough with mucus;

confusion, anxiety, panic attacks;

seizure (convulsions); or

worsening or no improvement in your symptoms of myasthenia gravis.

Less serious side effects may include:

cold sweat, pale skin;

urinating more than usual;

watery eyes;

mild nausea, vomiting, or upset stomach;

warmth or tingly feeling; or

mild rash or itching.

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 Mestinon Timespan (pyridostigmine)?

Tell your doctor about all other medicines you use, especially:

atropine (Atreza, Sal-Tropine);

belladonna (Donnatal, and others);

benztropine (Cogentin);

clidinium (Quarzan);

clozapine (Clozaril, FazaClo);

dimenhydrinate (Dramamine);

methscopolamine (Pamine), scopolamine (Transderm Scop);

glycopyrrolate (Robinul);

mepenzolate (Cantil);

bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);

bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);

cold medicine, allergy medicine, or sleeping pills that contain an antihistamine such as diphenhydramine (Tylenol PM) or doxylamine (Unisom);

heart rhythm medication such as quinidine (Quin-G), procainamide (Procan, Pronestyl), disopyramide (Norpace), flecaininde (Tambocor), mexiletine (Mexitil), propafenone, (Rythmol), and others;

irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro Banthine);

medicine to treat Alzheimer's dementia, such as donepezil (Aricept), rivastigmine (Exelon), or tacrine (Cognex); or

a steroid such as betamethasone (Celestone) or dexamethasone (Cortastat, Dexasone, Solurex, DexPak).

This list is not complete and other drugs may interact with pyridostigmine. 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 Mestinon Timespan resources Mestinon Timespan Side Effects (in more detail)Mestinon Timespan Use in Pregnancy & BreastfeedingDrug ImagesMestinon Timespan Drug InteractionsMestinon Timespan Support Group1 Review for Mestinon Timespan - Add your own review/rating Pyridostigmine Prescribing Information (FDA) Mestinon MedFacts Consumer Leaflet (Wolters Kluwer) Mestinon Prescribing Information (FDA) Pyridostigmine Bromide Monograph (AHFS DI) Regonol Prescribing Information (FDA) Compare Mestinon Timespan with other medications DysautonomiaMyasthenia GravisNerve Agent PretreatmentReversal of Nondepolarizing Muscle Relaxants Where can I get more information? Your pharmacist can provide more information about pyridostigmine.

See also: Mestinon Timespan side effects (in more detail)


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Mestinon Controlled-Release Tablets


Pronunciation: peer-id-oh-STIG-meen
Generic Name: Pyridostigmine
Brand Name: Mestinon
Mestinon Controlled-Release Tablets are used for:

Treating myasthenia gravis. It may also be used for other conditions as determined by your doctor.

Mestinon Controlled-Release Tablets are a cholinesterase inhibitor. It works by improving nerve impulses in muscles so that the muscles are better able to work.

Do NOT use Mestinon Controlled-Release Tablets if: you are allergic to any ingredient in Mestinon Controlled-Release Tablets you are taking quinine or quinidine you have a stomach, intestinal, or urinary blockage

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

Before using Mestinon Controlled-Release Tablets:

Some medical conditions may interact with Mestinon Controlled-Release Tablets. 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 problems (eg, heart block, slow heartbeat), a urinary tract infection, asthma, or kidney problems

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

Quinine or quinidine because effectiveness of Mestinon Controlled-Release Tablets may be decreased Succinylcholine because actions and side effects may be increased by Mestinon Controlled-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Mestinon Controlled-Release Tablets 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 Mestinon Controlled-Release Tablets:

Use Mestinon Controlled-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Mestinon Controlled-Release Tablets may be taken with or without food. Take with food if it upsets your stomach. Swallow Mestinon Controlled-Release Tablets whole. Do not break, crush, or chew before swallowing. If you miss a dose of Mestinon Controlled-Release Tablets, 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 Mestinon Controlled-Release Tablets.

Important safety information: Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Mestinon Controlled-Release Tablets. Use Mestinon Controlled-Release Tablets with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Mestinon Controlled-Release Tablets, discuss with your doctor the benefits and risks of using Mestinon Controlled-Release Tablets during pregnancy. Mestinon Controlled-Release Tablets are excreted in breast milk. If you are or will be breast-feeding while you are using Mestinon Controlled-Release Tablets, check with your doctor or pharmacist to discuss the risks to your baby. Possible side effects of Mestinon Controlled-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. 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; fainting; increased production of saliva; increased sweating; muscle weakness; nausea; small pupils; stomach cramps; trouble breathing; vision changes; vomiting; weakness.

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: Mestinon 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; fainting; increased production of saliva; increased sweating; muscle weakness; nausea; small pupils; stomach cramps; trouble breathing; vision changes; vomiting; weakness.

Proper storage of Mestinon Controlled-Release Tablets:

Store Mestinon Controlled-Release Tablets between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Mestinon Controlled-Release Tablets out of the reach of children and away from pets.

General information: If you have any questions about Mestinon Controlled-Release Tablets, please talk with your doctor, pharmacist, or other health care provider. Mestinon Controlled-Release Tablets are 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 Mestinon Controlled-Release Tablets. 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 Mestinon resources Mestinon Side Effects (in more detail) Mestinon Use in Pregnancy & Breastfeeding Drug Images Mestinon Drug Interactions Mestinon Support Group 6 Reviews for Mestinon - Add your own review/rating Compare Mestinon with other medications Dysautonomia Myasthenia Gravis Nerve Agent Pretreatment Reversal of Nondepolarizing Muscle Relaxants


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antimyasthenic Oral, Parenteral


Class Name: antimyasthenic (Oral route, Parenteral route)

Commonly used brand name(s)

In the U.S.

Aricept Cognex Exelon Mestinon Mestinon Timespan Mytelase Chloride Prostigmin Bromide Razadyne Razadyne ER Razadyne IR

In Canada

Reminyl

Available Dosage Forms:

Tablet Syrup Tablet, Extended Release Capsule, Extended Release Solution Tablet, Disintegrating Capsule Uses For This Medicine

Antimyasthenics are given by mouth or by injection to treat myasthenia gravis. Neostigmine may also be given by injection as a test for myasthenia gravis. Sometimes neostigmine is given by injection to prevent or treat certain urinary tract or intestinal disorders. In addition, neostigmine or pyridostigmine may be given by injection as an antidote to certain types of muscle relaxants used in surgery.

These medicines are available only with your doctor's prescription.

Before Using This Medicine Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

Although there is no specific information comparing use of antimyasthenics in children with use in other age groups, these medicines are not expected to cause different side effects or problems in children than they do in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is not much information comparing use of antimyasthenics in the elderly with use in other age groups, these medicines are not expected to cause different side effects or problems in older people than they do in younger adults.

Pregnancy

Antimyasthenics have not been reported to cause birth defects; however, muscle weakness has occurred temporarily in some newborn babies whose mothers took antimyasthenics during pregnancy.

Breast Feeding

Antimyasthenics have not been reported to cause problems in nursing babies.

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. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

Atropine Metoclopramide

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Succinylcholine 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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

Intestinal blockage or Urinary tract blockage or Urinary tract infection—These medicines may make the condition worse. Proper Use of This Medicine

Your doctor may want you to take this medicine with food or milk to help lessen the chance of side effects. If you have any questions about how you should be taking this medicine, check with your doctor.

Take this medicine only as directed. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

If you are taking this medicine for myasthenia gravis:

When you first begin taking this medicine, your doctor may want you to keep a daily record of: the time you take each dose. how long you feel better after taking each dose. how long you feel worse. any side effects that occur.

This is to help your doctor decide whether the dose of this medicine should be increased or decreased and how often the medicine should be taken in order for it to be most effective in your condition.

Dosing

The dose medicines in this class 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 these medicines. 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.

For ambenonium For oral dosage form (tablets): For myasthenia gravis: Adults and teenagers—At first, the dose is 5 milligrams (mg) three or four times per day. Then, if needed, the dose will be adjusted by your doctor. Children—The dose is based on body weight or size and must be determined by your doctor. The total daily dose is usually 300 micrograms (mcg) per kilogram (kg) (136 mcg per pound) of body weight or 10 mg per square meter of body surface area. This dose may be divided into three or four smaller doses. If needed, the total daily dose will be increased to 1.5 mg per kg (0.68 mg per pound) of body weight or 50 mg per square meter of body surface area. This dose may be divided into three or four smaller doses. For neostigmine For oral dosage form (tablets): For myasthenia gravis: Adults and teenagers—At first, the dose is 15 milligrams (mg) every three or four hours. Then, the dose is 150 mg taken over a twenty-four-hour period. Children—The dose is based on body weight or size and must be determined by your doctor. The total daily dose is usually 2 mg per kilogram (kg) (0.91 mg per pound) of body weight or 60 mg per square meter of body surface area. This dose may be divided into six to eight smaller doses. For injection dosage form: For myasthenia gravis: Adults and teenagers—The usual dose is 500 micrograms (mcg) injected into a muscle or under the skin. Children—The dose is based on body weight and must be determined by your doctor. It is usually 10 to 40 mcg per kg (4.5 to 18.2 mcg per pound) of body weight, injected into a muscle or under the skin, every two or three hours. For urinary tract or intestinal disorders: Adults and teenagers—The usual dose is 250 to 500 mcg, injected into a muscle or under the skin, as needed. Children—Use and dose must be determined by your doctor. For pyridostigmine For oral dosage forms (syrup and tablets): For myasthenia gravis: Adults and teenagers—At first, the dose is 30 to 60 milligrams (mg) every three or four hours. Then, the dose is 60 mg to 1.5 grams (usually 600 mg) per day. Children—The dose is based on body weight or size and must be determined by your doctor. The total daily dose is usually 7 mg per kilogram (kg) (3.2 mg per pound) of body weight or 200 mg per square meter of body surface area. This dose may be divided into five or six smaller doses. For long-acting oral dosage form (extended-release tablets): For myasthenia gravis: Adults and teenagers—The usual dose is 180 to 540 mg one or two times per day. Children—Dose must be determined by your doctor. For injection dosage form: For myasthenia gravis: Adults and teenagers—The usual dose is 2 mg, injected into a muscle or vein, every two or three hours. Children—The dose is based on body weight and must be determined by your doctor. It is usually 50 to 150 micrograms (mcg) per kg (22.7 to 68.1 mcg per pound) of body weight, injected into a muscle every four to six hours. Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Keep the syrup form of pyridostigmine from freezing.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

Symptoms of overdose Blurred vision clumsiness or unsteadiness confusion convulsions (seizures) diarrhea (severe) increase in bronchial secretions or watering of mouth (excessive) increasing muscle weakness (especially in the arms, neck, shoulders, and tongue) muscle cramps or twitching nausea or vomiting (severe) shortness of breath, troubled breathing, wheezing, or tightness in chest slow heartbeat slurred speech stomach cramps or pain (severe) unusual irritability, nervousness, restlessness, or fear unusual tiredness or weakness

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

Rare Redness, swelling, or pain at place of injection (for pyridostigmine injection only) skin rash (does not apply to ambenonium)

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:

More common Diarrhea increased sweating increased watering of mouth nausea or vomiting stomach cramps or pain Less common Frequent urge to urinate increase in bronchial secretions unusually small pupils unusual watering of eyes

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 Healthcare (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 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 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 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 HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.


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Pyridostigmine Tablets


Pronunciation: peer-id-oh-STIG-meen
Generic Name: Pyridostigmine
Brand Name: Mestinon
Pyridostigmine is used for:

Treating myasthenia gravis. It may also be used for other conditions as determined by your doctor.

Pyridostigmine is a cholinesterase inhibitor. It works by improving nerve impulses in muscles so that the muscles are better able to work.

Do NOT use Pyridostigmine if: you are allergic to any ingredient in Pyridostigmine you are taking quinine or quinidine you have a stomach, intestinal, or urinary blockage

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

Before using Pyridostigmine:

Some medical conditions may interact with Pyridostigmine. 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 problems (eg, heart block, slow heartbeat), a urinary tract infection, asthma, or kidney problems

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

Quinine or quinidine because effectiveness of Pyridostigmine may be decreased Succinylcholine because actions and side effects may be increased by Pyridostigmine

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pyridostigmine 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 Pyridostigmine:

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

Pyridostigmine may be taken with or without food. Take with food if it upsets your stomach. If you miss a dose of Pyridostigmine, 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 Pyridostigmine.

Important safety information: Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Pyridostigmine. Use Pyridostigmine with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Pyridostigmine, discuss with your doctor the benefits and risks of using Pyridostigmine during pregnancy. Pyridostigmine is excreted in breast milk. If you are or will be breast-feeding while you are using Pyridostigmine, check with your doctor or pharmacist to discuss the risks to your baby. Possible side effects of Pyridostigmine:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. 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; fainting; increased production of saliva; increased sweating; muscle weakness; nausea; small pupils; stomach cramps; trouble breathing; vision changes; vomiting; weakness.

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: Pyridostigmine 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; fainting; increased production of saliva; increased sweating; muscle weakness; nausea; small pupils; stomach cramps; trouble breathing; vision changes; vomiting; weakness.

Proper storage of Pyridostigmine:

Store Pyridostigmine between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pyridostigmine out of the reach of children and away from pets.

General information: If you have any questions about Pyridostigmine, please talk with your doctor, pharmacist, or other health care provider. Pyridostigmine 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 Pyridostigmine. 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 Pyridostigmine resources Pyridostigmine Side Effects (in more detail) Pyridostigmine Dosage Pyridostigmine Use in Pregnancy & Breastfeeding Drug Images Pyridostigmine Drug Interactions Pyridostigmine Support Group 12 Reviews for Pyridostigmine - Add your own review/rating Compare Pyridostigmine with other medications Dysautonomia Myasthenia Gravis Nerve Agent Pretreatment Reversal of Nondepolarizing Muscle Relaxants


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Metvixia


methyl aminolevulinate
Dosage Form: cream
FULL PRESCRIBING INFORMATION INDICATIONS AND USAGE

Metvixia Cream in combination with Aktilite CL128 lamp red light illumination is indicated for treatment of thin and moderately thick, non-hyperkeratotic, non-pigmented actinic keratoses of the face and scalp in immunocompetent patients. This photodynamic therapy should be used in conjunction with appropriate lesion preparation in the physician’s office when other therapies are considered medically less appropriate  [See Dosage and Administration (2)]

The safety and efficacy have not been established for the treatment of cutaneous malignancies or for skin lesions other than non-hyperkeratotic face and scalp actinic keratoses using PDT with Metvixia Cream. The safety and efficacy of Metvixia Cream have not been established in patients with immunosuppression, porphyria or pigmented actinic keratoses.

DOSAGE AND ADMINISTRATION

Photodynamic therapy (PDT) for non-hyperkeratotic actinic keratoses with Metvixia Cream is a multi-stage process as described below: Two treatment sessions one week apart should be administered. Not more than one gram (half tube) of Metvixia Cream should be applied per treatment session. Multiple lesions may be treated during the same treatment session using a total of one gram of Metvixia Cream. Lesion response should be assessed 3 months after the last treatment session. Nitrile gloves should be worn when applying and removing the cream.

The Aktilite CL128 lamp, which is equipped with light emitting diodes (LEDs), emits red light with a narrow spectrum at approximately 630 nm, and a half-width of approximately 20 nm. The light dose to be used is 37 J/cm2, and the lamp should be placed 50 to 80 mm from the skin. The area of skin that can be illuminated is 80 x 180 mm. Calibration by the operator is not needed, and the illumination time is calculated automatically. The LED panel window should be cleaned daily with a slightly moist clean cloth.

If Aktilite red light treatment is interrupted or stopped for any reason, it may be restarted. If the patient for any reason cannot have the red light treatment during the prescribed period after application (the 3 hour timespan), the cream should be rinsed off and the patient should protect the exposed area from sunlight, prolonged or intense light for at least 48 hours.

Use of Metvixia Cream without subsequent red light illumination is not recommended.

This product is to be used only by physicians in the physician’s office. Metvixia Cream is not for ophthalmic, oral or intravaginal use. Physicians should be knowledgeable about photodynamic therapy and familiar with the Aktilite Operators Manual prior to use of Metvixia Cream.

One Metvixia-PDT session consists of:

Lesion preparation [See Dosage and Administration (2.1)]

Application of Metvixia Cream [See Dosage and Administration (2.2)]

Application of occlusive dressing [See Dosage and Administration (2.3)]

Occlusion for 3 hours [See Dosage and Administration (2.4)]

Removal of excess cream with saline [See Dosage and Administration (2.5)]

Positioning Aktilite CL128 lamp [See Dosage and Administration (2.6)]

Illumination with red light (Aktilite CL128 lamp) [See Dosage and Administration (2.7)]

Lesion preparation Before applying Metvixia Cream, the surface of the lesions should be prepared with a small dermal curette to remove scales and crusts and roughen the surface of the lesion. This is to facilitate access of the cream and light to all parts of the lesion. Figure 1A Lesion debriding   Only nitrile gloves should be worn during this and subsequent steps and Universal Precautions should be taken. Vinyl and latex gloves do not provide adequate protection when using this product. Figure 1B Lesion debriding   Application of Metvixia Cream

Using a spatula, apply a layer of Metvixia Cream about 1 mm thick to the lesion and the surrounding 5 mm of normal skin. Do not apply more than one gram (half tube) of Metvixia Cream per treatment session.

Figure 2: Cream application   Occlusive Dressing

Cover - The area where the cream has been applied should then be covered with an occlusive, non-absorbent dressing for 3 hours. Multiple lesions may be treated during the same treatment session. Each treatment field is limited to an area of 80 x 180 mm.

Figure 3: Occlusive dressing application   Occlusion for 3 hours

(at least 2.5 hours, but no more than 4 hours). After Cream application, patients should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) during the period prior to Aktilite red light treatment. Exposure to light may result in a stinging and/or burning sensation and may cause erythema and/or edema of the lesions. Patients should protect treated areas from the sun by wearing a wide-brimmed hat or similar head covering of light-opaque material. Sunscreens will not protect against photosensitivity reactions caused by visible light. It has not been determined if perspiration can spread the Metvixia Cream outside the treatment site to the eyes or surrounding skin. The treated site should be protected from extreme cold with adequate clothing or remaining indoors between application of Metvixia Cream and Aktilite PDT light treatment.

Removal of Excess Cream with Saline

Following removal of the occlusive dressing, clean the area with saline and gauze. Wear nitrile gloves.

Figure 4: Cream removal   Positioning Aktilite CL128 Lamp

See Aktilite CL128 Operators Manual for specific warnings, cautions and instructions. If necessary adjust the dose to 37 J/cm2 . Calibration by the operator is not required. Position the lamp over the area to be illuminated by the use of guide light. The distance between the LED panel and the lesion surface should be 50 to 80 mm (2 to 3.2 in). Do not stare into the beam. The patient and operator should wear appropriate eye protection during illumination. Patient protective goggles or eye shields are dark or of metal to block visible light.

Figure 5: Positioning Aktilite CL128  

2.7 Illumination with Aktilite CL128 Lamp Red Light

The required illumination time (7-10 minutes) is calculated automatically, and remaining time will be displayed at the control panel. The illumination stops automatically. The illumination may be paused and started again. Patients should be advised that transient pain, burning or stinging at the target lesion sites may occur during the period of light exposure.

Figure 6: Illumination   DOSAGE FORMS AND STRENGTHS

16.8% cream in 2 g tubes

CONTRAINDICATIONS

Metvixia Cream is contraindicated in patients with cutaneous photosensitivity, or known allergies to porphyrins, and in patients with known sensitivities to any of the components of Metvixia Cream, which includes peanut and almond oil [See WARNINGS and PRECAUTIONS (5)]

WARNINGS AND PRECAUTIONS General

Metvixia Cream is intended for topical use in the physician’s office by physicians. Metvixia Cream has not been studied for more than one course which consists of two treatment sessions one week apart. There is no information available regarding the recurrence rate for lesions treated with this therapy. Clinical studies did not follow patients beyond 3 months, and the recurrence rate of treated lesions is unknown.

Photosensitivity

During the time period between the application of Metvixia Cream and exposure to Aktilite red light illumination, the treatment site will become photosensitive.

If for any reason the patient cannot have the Aktilite red light treatment after application of Metvixia Cream, the cream should be rinsed off, and the patient should protect the treated area from sunlight, prolonged or intense light for two days. Prolonged exposure for greater than 4 hours to Metvixia Cream should be avoided.

After Metvixia Cream application, patients should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) during the period prior to red light treatment. Exposure to light may result in a stinging and/or burning sensation and may cause erythema and/or edema of the lesions. Before exposure to sunlight, patients should, therefore, protect treated lesions from the sun by wearing a wide-brimmed hat or similar head covering of light-opaque material. Sunscreens will not protect against photosensitivity reactions caused by visible light. The treated site should be protected from extreme cold with adequate clothing or remaining indoors between application of Metvixia Cream and Aktilite red light treatment.

After illumination of Metvixia Cream, the area treated should be kept covered and away from light for at least 48 hours.

Because of the potential for skin to become photosensitized, the Metvixia Cream should be used by a trained physician to apply drug only to non-hyperkeratotic actinic keratoses and perilesional skin within 5 mm of the lesion. Redness, swelling, burning, and stinging are expected as a result of therapy; however, if these symptoms increase in severity and persist longer than 3 weeks, the patient should contact their doctor.

Hypersensitivity

Metvixia Cream has demonstrated a high rate of contact sensitization (allergenicity) [See ADVERSE REACTIONS (6.1)]. Care should be taken by the physician applying Metvixia Cream to avoid inadvertent skin contact. Nitrile gloves should be worn when applying and removing the cream. Vinyl and latex gloves do not provide adequate protection when using this product.

Metvixia Cream is formulated with peanut oil and refined almond oil.

Metvixia Cream has not been tested in patients who are allergic to peanuts.

Coagulation defects

Metvixia Cream has not been tested on patients with inherited or acquired coagulation defects.

Aktilite Lamp

Before operating the Aktilite CL128 lamp, personnel should refer to the Operators Manual for specific warnings, cautions and instructions. Care should be exercised when positioning and operating the lamp. During the red light illumination period, the patient, operator and other persons present should wear protective goggles that sufficiently screen out the appropriate spectrum of red light. The protective goggles or eye shields provided for the patient are dark or of metal to block visible light. The green professional protective glasses provided for the operator screen out the relevant spectrum of red light and the room will still appear bright for the operator to see. Do not stare into the beam. For lamp assembly, maintenance, service and technical data the personnel should refer to the Operators Manual.

ADVERSE REACTIONS Dermal Safety Studies

Studies in healthy volunteer subjects and subjects with actinic keratoses previously treated with Metvixia-PDT on at least 4 previous occasions have demonstrated that Metvixia Cream has the potential to cause irritancy and sensitization. A cumulative irritancy and sensitization (allergenicity) study of Metvixia Cream with a cross-sensitization challenge with aminolevulinic acid (ALA) was performed in 156 subjects. Metvixia Cream was applied 3 times each week for 3 weeks (total of 9 applications), to separate sites on the back of healthy volunteers. After each application, the area was covered by aluminum Finn Chamber. After the 3-week continuous treatment period and a 2-week interval without further applications, subjects were challenged with Metvixia Cream, Metvixia vehicle, ALA, and ALA-vehicle creams for 48 hours. Assessment of skin reactions was performed 48, 72, and 96 h after start of the challenge cream application. Only 98 of the 156 subjects tested entered the challenge phase because of a high incidence of local irritancy evident as erythema. Of the 58 subjects who were challenged with Metvixia Cream, 30 (52 %) showed contact sensitization. Of the 98 subjects who were challenged with ALA, only 2 (2 %) showed equivocal reactions the remaining subjects having negative responses.

The potential for sensitization was also assessed by patch testing a total of 21 patients with actinic keratoses previously treated with Metvixia-PDT on at least 4 previous occasions. Metvixia Cream 16.8 % and vehicle cream were applied to different sites on the lower back for 48 hours. Three of the 21 patients (14%) showed contact sensitization associated with erythema scores ?4 (strong erythema spreading outside the patch) and edema, vesiculation, papules and glazing.

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

A total of 231 subjects, each with 4 - 10 actinic keratoses were enrolled in 2 double-blind, randomized, vehicle-controlled clinical trials. Subjects were randomized to receive Aktilite PDT with Metvixia Cream 16.8 % or Vehicle cream on 2 occasions 1 week apart. Cream was applied for approximately 3 hours under occlusion followed immediately by illumination using the Aktilite CL128 lamp, delivering red light at a dose of 37 J/cm2.

Table 1 shows the incidence and severity of local (treatment site) adverse reactions in these two trials. The most frequent adverse reactions were associated with phototoxicity at the treatment site. Pain and burning sensation typically begin during illumination and generally resolve completely within a few minutes or hours, but may last up to a few days. Erythema and other signs generally resolve within a few days to 3 weeks.

In these two studies, out of 126 subjects treated with Metvixia Cream, six Metvixia Aktilite PDT subjects did not complete the full two treatment session regimen due to adverse reactions such as headache, pain or burning. These subjects either stopped illumination early or did not have the second treatment. In addition, 12 Metvixia PDT subjects paused illumination due to pain, burning or stinging but did subsequently complete treatment.

Table 1: Incidence of Treatment Site Adverse Reactions in ? 1% of Subjects in Studies 1 and 2 (Safety Population) Metvixia & Aktilite
PDT
n=126 Vehicle & Aktilite
PDT
n=105 * Mild, Moderate, or Severe Any Treatment Site
Adverse Reaction All Grades* Severe All Grades* Severe 113 (90%) 28 (22%) 48 (46%) 0 (0%)   Skin burning/pain/discomfort 109 (86%) 25 (20%) 38 (36%) 0 (0%) Erythema   80 (63%)   7 (6%) 11 (10%) 0 (0%) Scabbing/crusting/blister/erosions   36 (29%)   2 (2%)   1 (1%) 0 (0%) Pruritus   28 (22%)   0 (0%)   8 (8%) 0 (0%) Skin or eyelid edema   23 (18%)   2 (2%)   1 (1%) 0 (0%) Skin exfoliation   17 (14%)   4 (3%)   3 (3%) 0 (0%) Skin warm     5 (4%)   0 (0%)   2 (2%) 0 (0%) Application site discharge     3 (2%)   0 (0%)   0 (0%) 0 (0%) Skin hemorrhage     2 (2%)   0 (0%)   0 (0%) 0 (0%) Skin tightness     2 (2%)   0 (0%)   0 (0%) 0 (0%) Skin hyperpigmentation     2 (2%)   0 (0%)   0 (0%) 0 (0%) Postmarking Experience

The following adverse reactions have been identified during post approval use of Metvixia Cream outside of the United States. Because these reactions are reported voluntary from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Reports of serious adverse reactions at or near the application site include pain, erythema, edema, pustules, scab, crusting, and hyperpigmentation. Allergic reactions reported include eczema, allergic contact dermatitis and urticaria. Most cases were localized to the treatment area; rarely erythema and swelling have been more extensive. At sites distant from the application site there have been reports of squamous cell carcinoma of the skin, as expected in this population. There have been occasional reports of eye disorders including edema, eyelid swelling, macular edema, vitreous detachment and keratitis.

Drug Interactions

There have been no studies of the interaction of Metvixia Cream with other drugs, including local anesthetics. It is possible that concomitant use of other known photosensitizing agents might increase the photosensitivity reaction of actinic keratoses treated with Metvixia Cream.

USE IN SPECIFIC POPULATIONS   Pregnancy

Teratogenic effects: Pregnancy Category C:

There are no adequate and well-controlled studies with Metvixia Cream in pregnant women. Intravenous methyl aminolevulinate hydrochloride (HCI) was teratogenic in rabbits at a high dose. Metvixia Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

A Maximum Topical Human Dose (MTHD) of 2 g of Metvixia Cream 16.8% containing 420 mg methyl aminolevulinate hydrochloride corresponding to 7 mg/kg or 259 mg/m2 for a 60 kg patient and an estimated maximum systemic uptake of 1% was used for the animal multiple of human systemic exposure calculations presented in this labeling.

In development toxicity studies, pregnant rabbits received intravenous doses of methyl aminolevulinate hydrochloride up to 926 times the MTHD on Days 6 to 18 of gestation. Slightly lower fetal body weights and increased incidences of fetuses with jugals connected/fused to maxilla, supernumerary ribs, incompletely ossified cranial bones and other ossification irregularities were noted in the high dose (926 times the MTHD) group, compared to the control group. The embryo-fetal effects in the high dose group were associated with maternal toxicity. These effects did not occur at 463 times the MTHD based on mg/m2 comparisons and an estimated maximum systemic uptake of 1%. Developmental toxicity studies in rats were negative at daily exposure levels up to 1622 times the MTHD on a mg/m2 basis.

In the prenatal and postnatal development toxicity study, pregnant rats received intravenous doses of methyl aminolevulinate hydrochloride up to 1160 x the MTHD from Day 6 of gestation to Day 24 of lactation. There were no treatment-related effects on litter size, pup mortality, pup weights, or post weaning performance in the pups (including development and reproduction). A slightly longer duration of gestation and a slight delay in pup physical development were noted in the 580-1160 x the MTHD groups. [See Section 13.3]

  Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Metvixia Cream is administered to a nursing woman.

  Pediatric Use

Actinic keratosis is not a condition generally seen within the pediatric population. The safety and effectiveness in pediatric patients below the age of 18 have not been established.

  Geriatric Use

Of the 211 subjects in the clinical studies with Metvixia-PDT, 136 subjects were 65 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

OVERDOSAGE   Metvixia Cream Overdose

Metvixia Cream overdose has not been reported. If the patient for any reason cannot have the red light treatment during the prescribed period after application (the 3 hour timespan), the cream should be rinsed off with saline and water, and the patient should protect the exposed area from sunlight, prolonged or intense light for two days.

  Aktilite Red Light Overdose

Red light overdose (excess illumination time) using Aktilite CL128 following Metvixia Cream application has not been reported. If red light overexposure were to result in a burn, the patient should be treated in accordance with standard practice for treatment of cutaneous burns.

DESCRIPTION

Metvixia Cream is an oil in water emulsion. Metvixia Cream contains methyl aminolevulinate hydrochloride equivalent to 168 mg/g of methyl aminolevulinate.

Methyl aminolevulinate hydrochloride is a white to slightly yellow powder that is freely soluble in water and methanol, soluble in ethanol and practically insoluble in most organic solvents.

The chemical formula for methyl aminolevulinate HCl is C6H11NO3•HCl (MW=181.62) and it has the following structural formula:

Metvixia Cream, for topical use only, is cream to pale yellow in color, contains glyceryl monostearate, cetostearyl alcohol, polyoxyl stearate, cholesterol and oleyl alcohol as emulsifying agents. It also contains glycerin, white petrolatum, isopropyl myristate, peanut oil, refined almond oil as emollients, edetate disodium as a chelating agent and methylparaben and propylparaben as preservatives.

CLINICAL PHARMACOLOGY   Mechanism of Action

Photosensitization following application of Metvixia Cream occurs through the metabolic conversion of methyl aminolevulinate (prodrug) to photoactive porphyrins (PAPs), which accumulate in the skin lesions to which Metvixia Cream has been applied. When exposed to light of appropriate wavelength and energy, the accumulated photoactive porphyrins produce a photodynamic reaction, resulting in a cytotoxic process dependent upon the simultaneous presence of oxygen. The absorption of light results in an excited state of porphyrin molecules, and subsequent spin transfer from photoactive porphyrins to molecular oxygen generates singlet oxygen. Metvixia photodynamic therapy (PDT) of actinic (solar) keratosis lesions is the combination of photosensitization by topical application of Metvixia Cream to the lesions and subsequent illumination with red light of narrow spectrum using a light dose of 37 J/cm2 delivered by the Aktilite CL128 lamp.

  Pharmacokinetics

The time-course of Protoporphyrin IX in actinic keratosis lesions and surrounding skin after application of Metvixia Cream has been monitored by means of fluorescence. The optimum concentration of methyl aminolevulinate cream (16.8%) and duration of application (3 h) were derived from such studies of pharmacokinetics in skin using a range of concentrations (1.6%, 8% and 16.8%) and cream application times (up to 28 h). Three hours after the application of Metvixia Cream fluorescence in the treated lesions was significantly greater than that seen in both treated and untreated normal skin, and after application of vehicle cream (not containing methyl aminolevulinate) to normal skin. In a fluorescence study of 8 patients with actinic keratoses using Metvixia Cream 16.8% applied for 3 h and illumination with the Aktilite CL128 lamp, 88% photodegradation of Protoporphyrin IX was observed immediately after illumination, followed by a transient small secondary increase in fluorescence 2 hours after illumination. At 24 and 48 hours, 94% and 96% degradation of Protoporphyrin IX, respectively from baseline, was observed.

NONCLINICAL TOXICOLOGY   Carcinogenesis, Mutagenesis and Impairment of Fertility

Long-term studies to evaluate the carcinogenic potential of Metvixia Cream have not been performed. Methyl aminolevulinate was negative for genetic toxicity in the Ames assay, and the chromosomal aberration assay in Chinese hamster ovary cells, tested with and without metabolic activation and in the presence and absence of light. Methyl aminolevulinate was also negative in the in vivo micronucleus assay in the rat. In contrast, at least one report in the literature has noted genotoxic effects in cultured rat hepatocytes after aminolevulinate (ALA) exposure with PpIX formation. Other studies have documented oxidative DNA damage in vivo and in vitro as a result of ALA exposure.

A fertility study was performed in male and female rats with intravenous doses of methyl aminolevulinate hydrochloride up to 500 mg/kg/day (3000 mg/m2, 1158 times the MTHD based on mg/m2 comparisons and an estimated maximum systemic uptake of 1%). Males were treated for 4 weeks prior to mating and for 5 additional weeks after mating. The females were treated for 2 weeks prior to mating and then until Day 6 of gestation. There were no treatment-related effects on fertility and mating performance seen in this study.

  Reproductive Toxicology

Development toxicity studies have been performed in pregnant rats with intravenous doses of methyl aminolevulinate hydrochloride up to 700 mg/kg/day on Days 6 to 16 of gestation. There were no treatment-related effects on fetal body weight, sex ratio, external malformations and variations, and skeletal abnormalities and ossification extent. Only a slight non-significant increase in early embryonic death was noted in the 700 mg/kg/day group, compared to the control group. The fetal NOAEL (No Adverse Effect Level) was 350 mg/kg/day methyl aminolevulinate hydrochloride in pregnant rats (2100 mg/m2, 811 times the MTHD based on mg/m2 comparisons and an estimated maximum systemic uptake of 1%).

Development toxicity studies have also been performed in pregnant rabbits with intravenous doses of methyl aminolevulinate hydrochloride up to 200 mg/kg/day on Days 6 to 18 of gestation. Slightly lower fetal body weights and increased incidences of fetuses with jugals connected/fused to maxilla, supernumerary ribs, incompletely ossified cranial bones and other ossification irregularities were noted in the high dose (200 mg/kg/day) group, compared to the control group. The fetal NOAEL was 100 mg/kg/day methyl aminolevulinate hydrochloride in pregnant rabbits (1200 mg/m2, 463 times the MTHD based on mg/m2 comparisons and an estimated maximum systemic uptake of 1%).

In the prenatal and postnatal development toxicity study in rats treated with intravenous doses of methyl aminolevulinate hydrochloride up to 500 mg/kg/day from Day 6 of gestation to Day 24 of lactation, there were no treatment-related effects on litter size, pup mortality, pup weights, and post weaning performance of the F1 animals including development and reproductive capacity. Only a slightly longer duration of gestation and a slight delay in pup physical development were noted in the 250 and 500 mg/kg/day groups. The NOAEL was 125 mg/kg/day methyl aminolevulinate hydrochloride (750 mg/m2, 290 times the MTHD based on mg/m2 comparisons and an estimated maximum systemic uptake of 1%).

CLINICAL STUDIES

Metvixia Cream 16.8% for photodynamic therapy (PDT) by illumination using the Aktilite CL128 lamp was studied in 211 randomized subjects with a total of 1555 non-hyperkeratotic actinic keratoses in two multicenter, randomized, double-blind vehicle-controlled clinical trials. One study was conducted in the USA and the other in the USA and Germany.

Each subject had 4 to 10 previously untreated, nonpigmented, grade 1 (thin) or 2 (moderate) actinic keratoses on the face and or scalp. Grade 3 (very thick and obvious) actinic keratoses were not treated in the studies. Two sessions of PDT were administered at an interval of one week with patients randomized 1:1 to receive Metvixia-PDT or Vehicle-PDT on both occasions. Each session comprised lesion preparation (debridement with sharp curette) to roughen the surface, application of cream with subsequent maintenance for 3 hours under occlusion using an adhesive, non-absorbent dressing, removal of residual cream followed immediately by light activation. Red light illumination (630 nm) was provided by the Aktilite CL128 lamp and the light dose was 37 J/cm2.

The subject complete response rate was assessed 3 months after the last treatment. Lesion clinical complete response was defined as complete disappearance of a lesion upon visual inspection and palpation. If all treated lesions within a subject were in clinical complete response 3 months after treatment, the subject was assessed as a complete responder. The subject complete response rates are shown in Table 2 for each of the two studies.

Table 2:  Subject Complete Response after Lesion Debridement followed by Aktilite PDT with Metvixia Cream vs. Vehicle – Studies 1 and 2   Study 1 Study 2 Metvixia
n=49 Vehicle
n=47 Metvixia
n=57 Vehicle
n=58 Subjects with Complete
Response 29
59.2% 7
14.9% 39
68.4% 4
6.9%

The overall lesion complete response rates and the response rates by lesion grade and location are shown in Table 3 for the two studies.

Table 3:  Lesion Complete Response Rate by Grade and Location Studies 1 and 2 conducted with Aktilite photodynamic therapy   Study 1 Study 2   Metvixia
n=363 Vehicle
n=360 Metvixia
n=418 Vehicle
n=414 Lesions with Complete Response 313 (86%) 188 (52%) 348 (83%) 119 (29%)  
Grade 1   259 267 182 161 Face      Total 191 201 99 88      CR 167 (87%) 121 (60%) 90 (91%) 33 (38%)   Scalp      Total 68 66 76 73      CR 63 (93%) 29 (44%) 66 (87%) 31 (42%)    
Grade 2   104 93 236 253 Face      Total 76 68 119 157      CR 65 (86%) 29 (43%) 103 (87%) 35 (22%)   Scalp      Total 28 25 115 96      CR 18 (64%) 9 (36%) 89 (77%) 20 (21%)  

There was no difference between response rates to Metvixia Aktilite PDT for Grade 1 lesions on the face and scalp (CR rates of 89% and 90% respectively). For Grade 2 lesions, the corresponding CR rates to Metvixia Aktilite PDT were 86% and 75% respectively. Metvixia Cream has not been studied for more than one course which consists of two treatment sessions one week apart. There is no information regarding the recurrence rate for lesions treated with this therapy. Clinical studies did not follow patients beyond 3 months, and the recurrence rate of treated lesions is unknown.

HOW SUPPLIED/STORAGE AND HANDLING

Metvixia Cream, 16.8%, is available as the following:

2 gram aluminum tube, box of 1 (NDC 0299-6300-02)

Keep out of reach of children

For topical use only by physicians in the physician’s office. Dispense only to physicians and only to be applied by a physician.

Physicians should wear nitrile gloves when applying and removing Metvixia Cream. Vinyl and latex gloves do not provide adequate protection when using this product.

Store/Transport refrigerated, 2? - 8?C (36? - 46?F).

Use contents within one week after opening.

Should not be used after 24 hours out of refrigerator.

P24202-0 Revised: June 2008

Patient Counseling Information

The physician should provide and discuss the attached Patient Package Insert with each patient.

PATIENT INFORMATION

Metvixia (met vik see a)
(methyl aminolevulinate hydrochloride) Cream, 16.8%

Read this Patient Information before you are treated with Metvixia Cream and each time you are treated. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment. Ask your doctor provider about anything you do not understand about Metvixia Cream.

Important note: Metvixia Cream is for use on the skin only. Tell your doctor right away if Metvixia Cream gets in your eyes or mouth.          

What is the most important thing I need to know about Metvixia Cream?

Metvixia Cream with light treatment (Photodynamic therapy or PDT) is only done in medical offices by trained doctors.

Metvixia Cream is not applied by patients and should not be applied by doctors who have not been trained in its use.

Metvixia Cream is for use in PDT with the Aktilite CL128 lamp.

What is Metvixia Cream?

Metvixia Cream is a prescription cream used with PDT to treat skin growths on the face and scalp called actinic keratoses (AK). Metvixia Cream is only used for AK skin growths that are thin and not dark colored. AK skin growths are caused partly by too much sun exposure. Metvixia Cream and PDT work together to treat AK skin growths.

Metvixia Cream has not been studied in children for any condition and should not be used in children.

Who should not use Metvixia Cream?

Do not use Metvixia Cream if:

your skin over reacts to sun or light (photosensitivity). Talk with your doctor to be sure.

you are allergic to porphyrins or to any of the ingredients in Metvixia Cream including peanut and almond oil. See the end of this leaflet for a complete list of ingredients in Metvixia Cream.

What should I tell my doctor before treatment with Metvixia Cream?

Tell your doctor about all your medical conditions, including if you

have or had skin cancer or other skin growths on your body

have bleeding problems

are pregnant or planning to become pregnant. It is not known if Metvixia Cream can harm your unborn baby.

are breastfeeding. It is not known if Metvixia Cream passes into your milk and if it can harm your baby. You should decide whether or not to stop breastfeeding while getting treatment with Metvixia Cream. Talk to your doctor for help with this choice.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. It is not known if Metvixia Cream and other medicines can affect each other.

Know your medicines. Keep a list of your medicines and show it to your doctor and pharmacist when you start a new medicine.

How should I use Metvixia Cream?

Metvixia Cream and PDT treatment is only done by trained doctors.

You will receive 2 treatments with Metvixia Cream and PDT 1 week apart. Your doctor will check you three months after treatment to see if the treatment worked for you. (See the end of this leaflet for the section “Treatment with Metvixia Cream and PDT.”)

Metvixia Cream is for skin use only. Do not get Metvixia Cream in your eyes or mouth. Tell your doctor right away if this happens.

What should I avoid while using Metvixia Cream?

During the 3 hours that Metvixia Cream is on your skin:

Avoid sunlight or bright indoor light (for example: examination lights, operating room lights, tanning beds, or lights that are close to you.) During this time, the treated areas of your skin are more sensitive to light. You may feel burning or stinging. Your treated skin may become red or your lesions may become swollen. Wear a protective hat and clothing if you need to be outside in the sun.

Avoid cold temperatures. Wear warm clothing and keep your treated skin areas covered if you are in cold temperatures, or stay indoors.

After treatment with Metvixia Cream and PDT, avoid sunlight or bright indoor light (for example: examination lights, operating room lights, tanning beds or lights that are close to you) for two days. During this time, the treated areas of your skin are more sensitive to light. Keep the treated areas
of your skin covered. Wear a protective hat and clothing if you need to be outside in the sun.

If for any reason you are not treated with the lamp after Metvixia Cream has been applied to your skin:

Carefully rinse off the Cream.

Avoid sunlight, indoor light that is bright (for example: examination lights, operating room lights, tanning beds or lights that are close to you) for two days after treatment. During this time, the treated areas of your skin are more sensitive to light. Wear a protective hat and clothing if you need to be outside in the sun.

What are the possible side effects of Metvixia Cream with PDT treatment?

Common side effects of Metvixia Cream with PDT treatment include the following skin reactions at the treated site:

redness

pain

burning feeling

stinging

swelling

crusting, peeling, blisters, bleeding, itching ulcers

Burning pain and stinging usually decline over a few hours. If skin redness, swelling and other signs of inflammation get worse and last longer than 3 weeks, call your doctor.

Tell your doctor about any side effects that bother you or do not go away. Your doctor should be able to treat them if needed.

These are not all the side effects of Metvixia Cream with PDT. Ask your doctor or pharmacist for more information.

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

General information about Metvixia Cream

This leaflet summarizes the most important information about Metvixia Cream. If you would like more information, talk with your doctor. You can ask your doctor for information about Metvixia Cream that is written for health professionals.

What are the ingredients in Metvixia Cream?

Active Ingredient: methyl aminolevulinate hydrochloride.

Inactive Ingredients: Glyceryl monostearate, cetostearyl alcohol, poloxyl stearate, cholesterol, oleyl alcohol glycerin, white petrolatum, isopropyl myristate, peanut oil, refined almond oil, edetate disodium, methylparaben and propylparaben.

Treatment with Metvixia Cream and PDT

Figure 1: Lesion debriding
Your doctor will prepare your skin by gently scraping (debriding) your skin growths before treating with Metvixia Cream and PDT. A small skin scraper is used to remove scales and crusts and to roughen the surface of any skin growths. This is to help Metvixia Cream and PDT to reach all parts of the skin growths. Figure 2: Cream application
Metvixia Cream is applied to the actinic keratosis skin growths and to a small area of the skin around the growths. Figure 3: Clear bandage application
The treated skin areas will be covered with a special clear bandage for about 3 hours.

During these 3 hours avoid sunlight or bright indoor light (for example: examination lights, operating room lights, tanning beds or lights that are close to you). During this time, the treated areas of your skin are more sensitive to light. You may feel burning or stinging. Your treated skin area may turn red or become swollen (photosensitive reactions). Wear a hat and protective clothes if you need to be out in the sun during this time. Sunscreens will not help protect your treated skin during this time. In cold weather, protect your treated skin site from the cold with warm clothes or stay indoors for these 3 hours between the cream and light treatment.

Figure 4: Cream removal
The bandage will be removed and the area will be rinsed with a saline solution before the PDT (light) treatment. Figure 5: Positioning the lamp
The lamp will be positioned over the area to be illuminated by the use of guide light of reduced intensity. The distance between the lamp and the skin will be 50 to 80 mm (2-3.2 inch).


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