Mycophenolate mofetil (oral/injection)

Mycophenolate mofetil is used to stop the body from rejecting a liver, kidney, or heart transplant in people who are at least 3 months old. Mycophenolate mofetil is also used along with other medicines to prevent organ transplant rejection.

Mycophenolate mofetil may also be used for other reasons that are not mentioned in this medication guide.

Follow all the instructions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. You must stay under the care of a doctor while you are using mycophenolate mofetil.

Mycophenolate mofetil injection is given as an infusion into a vein. A healthcare provider will give you this injection.

Take oral mycophenolate mofetil on an empty stomach, at least 1 hour before or 2 hours after a meal.

Swallow the capsule or tablet whole and do not crush, chew, break, or open it. Tell your doctor if you have trouble swallowing a tablet or capsule.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Shake the oral suspension (liquid) before you measure a dose. Use only the dosing syringe provided with mycophenolate mofetil.

Mycophenolate mofetil (CellCept) and mycophenolic acid (Myfortic) are not absorbed equally in the body. Avoid medication errors by using only the brand, form, and strength of this medicine that your doctor has prescribed.

You will need frequent medical tests.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use. Throw away any unused liquid that is older than 60 days.

The liquid medicine may also be stored in the refrigerator. Do not freeze.

mycophenolate mofetil can cause a miscarriage or birth defects if used during pregnancy. Both men and women must use effective birth control to prevent pregnancy during and shortly after treatment with mycophenolate mofetil.

You should not use this medicine if you are allergic to mycophenolate mofetil, mycophenolic acid, or polysorbate 80.

Talk with your doctor about the risks and benefits of mycophenolate mofetil. This medicine may increase your risk of cancer, serious or fatal infections, or a viral infection that can cause kidney transplant failure.

Tell your doctor if you have ever had:

• a stomach ulcer or problems with digestion, diabetes;
• hepatitis B or C or other viral infection (may become active or get worse while you are using mycophenolate mofetil);
• phenylketonuria, or PKU (the liquid form of this medicine may contain phenylalanine); or
• a rare inherited enzyme deficiency such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome.

This medicine can cause a miscarriage or birth defects, especially during the first 3 months of pregnancy. You will need to have a negative pregnancy test before and during treatment with this medicine. If you are able to get pregnant, you must use specific forms of birth control to prevent pregnancy while using mycophenolate mofetil, and for at least 6 weeks after your last dose. Sexually active men and their partners should use effective contraception during treatment and for at least 90 days after the last dose.

Mycophenolate mofetil can make birth control pills less effective. Ask your doctor about using an additional barrier form of birth control (condom, diaphragm, cervical cap, or contraceptive sponge) to prevent pregnancy.

You do not need to use additional birth control if you use an intrauterine device (IUD), if you have had a tubal ligation, or if your sexual partner has had a vasectomy.

This medicine comes with patient instructions about the most effective non-hormonal forms of birth control to use. Follow these directions carefully. Ask your doctor if you have any questions.

If a pregnancy occurs during treatment, do not stop taking mycophenolate mofetil. Call your doctor for instructions. Also call the Mycophenolate Pregnancy Registry (1-800-617-8191).

Mycophenolate mofetil is sometimes given to pregnant women. Your doctor will decide whether you should use this medicine if you are unable to use other needed transplant medications.

You should not breastfeed while using mycophenolate mofetil.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Mycophenolate mofetil may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start slowly and get worse quickly.

Mycophenolate mofetil affects your immune system and may increase your risk of cancer or serious infection. Call your doctor right away if you have:

• fever of 100.5 degrees F or higher, swollen glands, painful mouth sores, cold or flu symptoms, headache, ear pain, loss of smell or taste, stomach pain, vomiting, diarrhea, weight loss;
• weakness on one side of your body, loss of muscle control, confusion, thinking problems, loss of interest in things that normally interest you;
• pain around the transplanted kidney, pain or burning when you urinate, dark urine, jaundice (yellowing of the skin or eyes);
• tingly or painful blistering rash on one side of your body, swelling, warmth, redness, or oozing around a skin wound; or
• a new skin lesion, or a mole that has changed in size or color.

Also call your doctor at once if you have:

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds, fever, joint stiffness and pain, and muscle pain; or
• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects of mycophenolate mofetil may include:

• stomach pain, nausea, vomiting, diarrhea, constipation, swelling in your ankles or feet, rash, pain anywhere in your body;
• headache, dizziness, tremors, fever, sore throat, cold symptoms, or other signs of infections; or
• abnormal blood tests, high blood sugar, high or low blood pressure, fast heart rate.

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.

Usual Adult Dose for Organ Transplant -- Rejection Prophylaxis:

-RENAL TRANSPLANTATION: 1 g orally or IV 2 times a day (2 gm per day); [in clinical trials, 1.5 g orally or IV 2 times a day (3 gm per day) was used effectively, however, the safety profile for 3 gm a day was lower] -CARDIAC TRANSPLANTATION: 1.5 g orally or IV 2 times a day (3 gm per day)-HEPATIC TRANSPLANTATION: 1.5 gm orally or 1 gm IV 2 times a day (3 gm per day orally or 2 gm per day IV)Comments:-This drug should be used concomitantly with cyclosporine and corticosteroids.-The IV formulation should be administered over no less than 2 hours.-IV administration is recommended in patients unable to take oral medication; oral administration should be initiated as soon as possible.

Usual Geriatric Dose for Organ Transplant -- Rejection Prophylaxis:

-RENAL TRANSPLANTATION: 1 g orally or IV 2 times a day (2 gm per day)-CARDIAC TRANSPLANTATION: 1.5 g orally or IV 2 times a day (3 gm per day)-HEPATIC TRANSPLANTATION: 1.5 gm orally or 1 gm IV 2 times a day (3 gm per day orally or 2 gm per day IV)Comments:-This drug should be used concomitantly with cyclosporine and corticosteroids.-The IV formulation should be administered over no less than 2 hours.-IV administration is recommended in patients unable to take oral medication; oral administration should be initiated as soon as possible.

Usual Pediatric Dose for Organ Transplant -- Rejection Prophylaxis:

-RENAL TRANSPLANTATION:3 months to 18 years of age:Oral Suspension: 600 mg/m2 orally 2 times a day up to a maximum of 2 grams per day-Pediatric patients with a body surface area of 1.25 to 1.5 m2 may be dosed with the oral capsules at 750 mg orally 2 times a day (1.5 g per day)-Pediatric patients with a body surface area greater than 1.5 m2 may be dosed with the oral capsules at 1 g orally 2 times a day (2 g per day)Comments:-This drug should be used concomitantly with cyclosporine and corticosteroids.-The IV formulation should be administered over no less than 2 hours.-IV administration is recommended in patients unable to take oral medication; oral administration should be initiated as soon as possible.

Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 2 hours. Do not use two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid driving or hazardous activity until you know how mycophenolate mofetil will affect you. Your reactions could be impaired.

Mycophenolate mofetil can make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Do not receive a "live" vaccine while using mycophenolate mofetil. The vaccine may not work as well and may not fully protect you from disease.

You must not donate blood or sperm while using this medicine, and for at least 6 weeks (for blood) or 90 days (for sperm) after your last dose.

If you take sevelamer or an antacid, take your oral mycophenolate mofetil dose 2 hours before you take these other medicines.

Sometimes it is not safe to use certain medications at the same time. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can affect mycophenolate mofetil, especially:

• azathioprine, cholestyramine;
• antiviral medicine--acyclovir, ganciclovir, valacyclovir, valganciclovir;
• an antibiotic--amoxicillin, ciprofloxacin, metronidazole, norfloxacin, rifampin, sulfa drugs; or
• a stomach acid reducer--esomeprazole, lansoprazole, omeprazole, Nexium, Prevacid, Prilosec, Protonix, and others.

This list is not complete and many other drugs may affect mycophenolate mofetil. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.