Mycophenolate Mofetil Hydrochloride (mye-koe-FEN-oh-late MOE-fe-til hye-droe-KLOR-ide)

Prevents your body from rejecting an organ (including kidney, liver, or heart) after transplant by suppressing your immune system.

Brand Name(s):

Cellcept

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein. This medicine must be given slowly, so the needle will remain in place for at least 2 hours.
• A nurse or other health provider will give you this medicine.
• You will receive this form of the medicine for a short time until your condition improves. Then you will be switched you to an oral form that works the same way. If you have any questions about this, talk to your doctor.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how mycophenolate works. Tell your doctor if you are using acyclovir, azathioprine, cholestyramine, cyclosporine, isavuconazole, metronidazole, lansoprazole, norfloxacin, pantoprazole, probenecid, rifampin, telmisartan, trimethoprim/sulfamethoxazole, or valacyclovir. Tell your doctor if you are also using birth control pills or a proton pump inhibitor (PPI) medicine for heartburn.
• If you are using sevelamer or an antacid that contains aluminum or magnesium, take it at least 2 hours after taking this medicine.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can get pregnant, your doctor may give you a pregnancy test before you start using this medicine and 8 to 10 days after using this medicine to make sure you are not pregnant. Birth control pills may not work as well when used with this medicine. Use two forms of effective birth control (including a condom, diaphragm, or contraceptive foam or jelly) during treatment and for at least 6 weeks after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 90 days after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.
• Do not donate sperm during treatment and for at least 90 days after the last dose.
• Tell your doctor knows if you are breastfeeding or if you have kidney disease, bone marrow problems, high blood pressure, stomach ulcers or other digestive problems, or rare genetic disease (including Lesch-Nyhan syndrome, Kelley-Seegmiller syndrome).
• This medicine may cause the following problems:
  • Increased risk of cancer (including skin cancer, lymphoma)
  • Increased risk of serious infections
  • Inflammatory (swelling) reactions
  • Reactivation of hepatitis B or C infection
  • Pure red cell aplasia (PRCA)
  • Stomach bleeding or ulcers
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, painful urination, unusual swelling
• Difficulty moving, joint or muscle pain
• Fever, chills, cough, sore throat, body aches, runny nose, nausea, vomiting, diarrhea, or other symptoms of infection
• Severe stomach pain, vomiting blood, bloody or black, tarry stools
• Skin lump or growth, brown or black patches on your skin, changes to a skin mole
• Unusual bleeding, bruising, or weakness
• Weakness on one side of the body, confusion, clumsiness, loss of interest in things, trouble thinking clearly

If you notice these less serious side effects, talk with your doctor:

• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

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