Mycophenolate

Brand Name(s):

• CellCept®
• Myfortic®

IMPORTANT WARNING

Risk of birth defects:

Mycophenolate must not be taken by women who are pregnant or who may become pregnant. There is a higher risk that mycophenolate will cause miscarriage (loss of the pregnancy) during the first 3 months of pregnancy or will cause the baby to be born with birth defects (problems that are present at birth).

You should not take mycophenolate if you are pregnant or if you may become pregnant. You must have a negative pregnancy test within 1 week of the start of your treatment with mycophenolate. You must use two acceptable forms of birth control together for 4 weeks before you begin to take mycophenolate, at all times during your treatment, and for 6 weeks after you stop taking mycophenolate. Your doctor will tell you which forms of birth control are acceptable for you to use. Mycophenolate may decrease the effectiveness of oral contraceptives (birth control pills), so it is especially important to use a second form of birth control along with this type of contraceptive.

Call your doctor right away if you think you are pregnant or if you miss a menstrual period.

Risks of serious infections:

Mycophenolate weakens the body's immune system and may decrease your ability to fight infection. Wash your hands often and avoid people who are sick while you are taking this medication. If you experience any of the following symptoms, call your doctor immediately: fever, sore throat, chills, or cough; unusual bruising or bleeding; pain or burning during urination; frequent urination; wound or sore that is red, warm, or won't heal; drainage from a skin wound; general weakness, extreme tiredness, or sick feeling; symptoms of the ''flu'' or a ''cold''; pain or swelling in the neck, groin, or armpits; white patches in the mouth or throat; cold sores; blisters; headache or earache; or other signs of infection.

Mycophenolate may increase the risk that you will develop progressive multifocal leukoencephalopathy (PML; a rare infection of the brain that cannot be treated, prevented, or cured and that usually causes death or severe disability). Tell your doctor if you have or have ever had PML, or another condition that affects your immune system such as human immunodeficiency virus (HIV); acquired immunodeficiency syndrome (AIDS); sarcoidosis (a condition that causes swelling in the lungs and sometimes in other parts of the body); leukemia (cancer that causes too many blood cells to be produced and released into the bloodstream); or lymphoma. If you experience any of the following symptoms, call your doctor immediately: weakness on one side of the body or in the legs; difficulty or inability to control your muscles; confusion or difficulty thinking clearly; unsteadiness; memory loss; difficulty speaking or understanding what others say; or a lack of interest or concern for usual activities or things you usually care about.

Mycophenolate may increase your risk of developing certain types of cancer, including lymphoma (a type of cancer that develops in the lymph system) and skin cancer. Tell your doctor if you or anyone in your family has or has ever had skin cancer. Avoid unnecessary or prolonged exposure to real and artificial sunlight (tanning beds, sunlamps) and light therapy and wear protective clothing, sunglasses, and sunscreen (with a SPF factor of 30 or above). This will help to decrease your risk of developing skin cancer. Call your doctor if you experience any of the following symptoms: pain or swelling in the neck, groin, or armpits; a new skin sore or bump; a change in the size or color of a mole; a brown or black skin lesion (sore) with uneven edges or one part of the lesion that does not look like the other; skin changes; sores that do not heal; unexplained fever; tiredness that does not go away; or weight loss.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with mycophenolate and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website Web Siteto obtain the Medication Guide.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to mycophenolate.

Talk to your doctor about the risks of taking mycophenolate.

WHY is this medicine prescribed?

Mycophenolate (CellCept) is used with other medications to help prevent transplant organ rejection (attack of the transplanted organ by the immune system of the person receiving the organ) in people who have received kidney, heart, and liver transplants. Mycophenolate (Myfortic) is used with other medications to help prevent the body from rejecting kidney transplants. Mycophenolate is in a class of medications called immunosuppressive agents. It works by weakening the body's immune system so it will not attack and reject the transplanted organ.

HOW should this medicine be used?

Mycophenolate comes as a capsule, a tablet, a delayed-release tablet, and a suspension (liquid) to take by mouth. It is usually taken twice a day on an empty stomach (1 hour before or 2 hours after eating or drinking, unless your doctor tells you otherwise). Take mycophenolate at about the same times every day, and try to space your doses about 12 hours apart. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take mycophenolate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

The medication in the delayed-release tablet (Myfortic) is absorbed differently by the body than the medication in the tablet and capsule (CellCept). These products cannot be substituted for each other. Each time you have your prescription filled, make sure that you have received the right product. If you think you received the wrong medication, talk to your doctor and pharmacist right away.

Swallow the tablets, delayed-release tablets, and capsules whole; do not split, chew, or crush them. Do not open the capsules.

Do not mix mycophenolate suspension with any other medication.

Be careful not to spill the suspension or to splash it onto your skin. If you do get the suspension on your skin, wash the area well with soap and water. If you get the suspension in your eyes, rinse with plain water. Use wet paper towels to wipe up any spilled liquids.

Mycophenolate helps prevent organ transplant rejection only as long as you are taking the medication. Continue to take mycophenolate even if you feel well. Do not stop taking mycophenolate without talking to your doctor.

Are there OTHER USES for this medicine?

Mycophenolate is also used to treat Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever). Talk to your doctor about the possible risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking mycophenolate,

• tell your doctor and pharmacist if you are allergic to mycophenolate, mycophenolic acid, or any other medications. If you are taking mycophenolate liquid, tell your doctor and pharmacist if you are allergic to aspartame or sorbitol.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: activated charcoal; acyclovir (Zovirax); amoxicillin and clavulanic acid (Augmentin); antibiotics; azathioprine (Azasan, Imuran); cholestyramine (Prevalite, Questran); ciprofloxacin (Cipro); colestipol (Colestid); ganciclovir (Cytovene); other medications that suppress the immune system; probenecid (Benemid); rifampin (Rifadin, Rimactane); salicylate pain relievers such as aspirin, choline magnesium trisalicylate (Trisalate), choline salicylate (Arthropan), diflunisal (Dolobid), magnesium salicylate (Doan's, others) and salsalate (Argesic, Disalcid, Salgesic); sulfamethoxazole/trimethoprim (Bactrim); valacyclovir (Valtrex); and valganciclovir (Valcyte). Also tell your doctor if you are taking a combination of both norfloxacin (Noroxin) and metronidazole (Flagyl). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are taking antacids, take them 2 hours before or 4 hours after you take mycophenolate. If you are taking sevelamer (Renagel, Renvela), take it 2 hours after you take mycophenoate.
• tell your doctor if you have or have ever had Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome (inherited diseases that cause high levels of a certain substance in the blood, joint pain, and problems with motion and behavior); ulcers or any disease that affects your stomach, intestines, or digestive system; any type of cancer; or kidney or liver disease.
• tell your doctor if you are breast-feeding.
• do not have any vaccinations without talking to your doctor. Ask your doctor if you should get a flu vaccine before or during your treatment because taking mycophenolate may increase your risk of infection.
• if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that mycophenolate suspension contains aspartame, a source of phenylalanine.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Mycophenolate suspension may also be stored in a refrigerator. Do not freeze mycophenolate suspension. Throw away any unused mycophenolate suspension after 60 days and throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• stomach pain
• nausea
• vomiting
• heartburn
• diarrhea
• fever, sore throat, chills, cough and other signs of infection

What OTHER INFORMATION should I know?

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: December 1, 2009.