When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use if you had an allergic reaction to mycophenolate, or if you are pregnant.

How to Use This Medicine:
Capsule, Liquid, Tablet, Coated Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Take this medicine on an empty stomach at least 1 hour before or 2 hours after you eat. Swallow the capsule or tablet whole. Do not break, crush, open, or chew. Tell your doctor if you cannot tolerate taking the medicine on an empty stomach.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup. Do not mix with any other medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the oral liquid at room temperature or in the refrigerator, for up to 60 days. Do not freeze.

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, ganciclovir, metronidazole, norfloxacin, probenecid, rifampin, sevelamer, valacyclovir, or valganciclovir. Tell your doctor if you are also using birth control pills.
• Do not take an antacid that contains aluminum and magnesium at the same time that you take mycophenolate.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. A woman should have a pregnancy test before using this medicine and during follow-up appointments.
• Talk with your doctor about birth control use during treatment and for at least 6 weeks after you stop using this medicine. You may need to use 2 methods, including a barrier method. Birth control pills may not work as well when used with this medicine.
• Tell your doctor if you are breastfeeding or if you have kidney disease, high blood pressure, or stomach ulcers or other digestive problems.
• This medicine may cause the following problems:
  
  • Higher risk of skin cancer or lymphoma
  • Higher risk of infections (including virus, bacteria, fungus, and protozoa)
  • Reactivation of hepatitis B or C infection
  • Pure red cell aplasia (PRCA) or other blood problems (such as anemia)
  • 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.
• The oral liquid contains aspartame, which is a source of phenylalanine. Make sure your doctor knows if you have phenylketonuria.
• 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.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• 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:

• Trouble sleeping
• Constipation, nausea, diarrhea, vomiting

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