Consumer Drug Information

Mycophenolate Mofetil

Generic Name: Mycophenolate Mofetil Tablets (MYE-koe-FEN-oh-late MOE-feh-til)
Brand Name: CellCept

Mycophenolate Mofetil weakens your immune system, which may decrease your ability to fight illness or infection. It may also increase the risk of certain types of cancer (eg, lymphoma). Use Mycophenolate Mofetil only under close medical supervision.

Mycophenolate Mofetil may cause birth defects or fetal death if taken during pregnancy. Women who may become pregnant must use effective birth control while they are taking Mycophenolate Mofetil .

Mycophenolate Mofetil is used for:

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Preventing organ rejection following kidney, liver, or heart transplants. Mycophenolate Mofetil is used in combination with other medicines. It may also be used for other conditions as determined by your doctor.

Mycophenolate Mofetil is an immunosuppressant. It works by decreasing the activity of certain cells that make up part of the immune system to help reduce the risk of organ transplant rejection.

Do NOT use Mycophenolate Mofetil if:

you are allergic to any ingredient in Mycophenolate Mofetil
you are taking azathioprine, cholestyramine, colestipol, or mycophenolic acid

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

Before using Mycophenolate Mofetil :

Some medical conditions may interact with Mycophenolate Mofetil . 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 stomach or intestinal problems, including ulcers, kidney problems, or a rare hereditary deficiency of hypoxanthine guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome
if you are scheduled for a vaccination

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

Antacids, cholestyramine, colestipol, or iron salts (eg, ferrous sulfate) because they may decrease Mycophenolate Mofetil 's effectiveness
Acyclovir, azathioprine, ganciclovir, mycophenolic acid, or probenecid because they may increase the risk of Mycophenolate Mofetil 's side effects
Oral contraceptives because their effectiveness may be decreased by Mycophenolate Mofetil

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

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

Take Mycophenolate Mofetil on an empty stomach at least 1 hour before or 2 hours after eating.
Swallow Mycophenolate Mofetil whole. Do not break, crush, or chew before swallowing.
Do not take an antacid that has aluminum or magnesium in it or an iron salt (eg, ferrous fumarate) at the same time as you take Mycophenolate Mofetil ; space the doses at least 3 to 4 hours apart.
If you miss a dose of Mycophenolate Mofetil , 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 Mycophenolate Mofetil .

Important safety information:

Mycophenolate Mofetil may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Mycophenolate Mofetil with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Women who may become pregnant must have a negative pregnancy test with 1 week before starting Mycophenolate Mofetil .
Women who may become pregnant must use 2 effective forms of birth control for 4 weeks before they start Mycophenolate Mofetil , during treatment, and for 6 weeks after they stop Mycophenolate Mofetil . Check with your doctor if you have any questions about effective birth control.
Hormonal birth control (eg, birth control pills) may not work as well while you are taking Mycophenolate Mofetil . Discuss any questions or concerns with your doctor.
Mycophenolate Mofetil may increase your risk of developing certain types of cancer (eg, lymphoma, skin cancer). Avoid the sun, sunlamps, or tanning booths until you know how you react to Mycophenolate Mofetil . Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
Mycophenolate Mofetil 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.
Do not receive a live vaccine (eg, measles, mumps) while you are taking Mycophenolate Mofetil . Talk with your doctor before you receive any vaccine.
Proper dental care is important while you are taking Mycophenolate Mofetil . Brush and floss your teeth and visit the dentist regularly.
Lab tests, including complete blood cell counts, may be performed while you use Mycophenolate Mofetil . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
PREGNANCY and BREAST-FEEDING: Mycophenolate Mofetil may cause birth defects or fetal death of you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if Mycophenolate Mofetil is found in breast milk. Do not breast-feed while taking Mycophenolate Mofetil .

Possible side effects of Mycophenolate Mofetil :

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:

Acne; anxiety; back pain; constipation; diarrhea; dizziness; headache; increased hair growth; indigestion; loss of appetite; mild or moderate stomach pain; muscle cramps; muscle or joint pain; nausea; pain; pain in arms or legs; pain, redness, or swelling at the injection site; shakiness; sleeplessness; stomach bloating; vomiting; weight gain.

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); blood in urine; bloody or black stools; change in the amount of urine produced; changes in balance, vision, or speech; changes in heart rhythm; chest pain; enlarged lymph nodes; enlarged stomach; fainting; fever, chills, cough, or sore throat; leg pain; mental or mood changes (eg, abnormal thinking); night sweats; pounding in the chest; severe vomiting or stomach pain; skin growths; stiff neck; swelling of the hands, ankles, or feet; swollen glands; symptoms of urinary tract infection (eg, difficult, frequent, or painful urination; lower back or stomach pain); unusual bruising or bleeding; unusual lumps or growths; unusual tiredness or weakness; vomiting blood that looks like coffee grounds; weight loss; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http: / / www.aapcc.org / dnn / Resources / FindLocalPoisonCenters / tabid / 130 / Default.aspx), or emergency room immediately. Symptoms may include diarrhea; nausea; vomiting.

Proper storage of Mycophenolate Mofetil :

Store Mycophenolate Mofetil at 77 degrees F (25 degrees C) in a tightly closed container. 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 Mycophenolate Mofetil out of the reach of children and away from pets.

General information:

If you have any questions about Mycophenolate Mofetil , please talk with your doctor, pharmacist, or other health care provider.
Mycophenolate Mofetil 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 Mycophenolate Mofetil . 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: August 6, 2008

Database Edition 08.3.1.002