WHO IS CELLCEPT FOR?

CellCept® (mycophenolate mofetil) is a medicine given by prescription to people who had a kidney, heart or liver transplant. CellCept can help prevent rejection of the new organ.

Your body's immune system can tell that the new heart, liver or kidney is different and tries to reject it. CellCept is taken along with other anti-rejection medicines to help control your immune system. They help keep it from rejecting the transplant.

Follow your doctor's exact orders for taking CellCept and all other medicines.

IMPORTANT SAFETY INFORMATION
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT CELLCEPT?

• Pregnant women who take CellCept have a higher chance of losing the baby during the first 3 months of pregnancy. There also is a higher chance the baby will have birth defects.

  You should have one pregnancy test immediately before starting CellCept and another pregnancy test 8 to 10 days later. Pregnancy tests should be repeated during routine follow-up visits with your doctor. Talk to your doctor about the results of all of your pregnancy tests.

  If you are a woman who can get pregnant, you must use acceptable birth control during your entire CellCept therapy, and continue birth control for 6 weeks after you stop taking CellCept, unless you choose to abstain from sexual intercourse with a man completely.

  If you plan to become pregnant, talk with your doctor. You and your doctor can decide if other medicines to prevent rejection may be right for you.

  If you become pregnant while taking CellCept, do not stop taking CellCept. Call your doctor right away. In certain situations, you and your doctor may decide that taking CellCept is more important to your health than the possible risks to your unborn baby.

  • You and your doctor should report your pregnancy to
    • Mycophenolate Pregnancy Registry (1-800-617-8191)

  The purpose of this registry is to gather information about the health of you and your baby.

• Taking CellCept with other anti-rejection medicines may raise your chance of getting an infection. It may raise your chance of getting cancer of the immune system (lymphoma) or other cancers, such as skin cancer. Talk with your doctor right away if you have any signs of infection such as fever, tiredness, headache, redness of skin/wound or swollen lymph glands. Tell your doctor about any changes in your skin.

• CellCept weakens the body's immune system and affects your ability to fight infections. Serious infections, possibly leading to death, can happen with CellCept. Types of infections can include:

  • Viral infections. Certain viruses can live in your body and cause active infections when your immune system is weak. These may include:

    • BK virus. This infection can damage the kidney. It can cause the new kidney to fail.

    • Cytomegalovirus (CMV). CMV can cause serious tissue and blood infections.

  • Brain infection called progressive multifocal leukoencephalopathy (PML). PML can be fatal. Symptoms include clumsiness, weakness that keeps getting worse, not being able to move or use one side of the body, and changes in vision, speech or personality.

  • Fungal infections. Yeasts and other types of fungal infections can happen with CellCept and can cause serious tissue and blood infections.

WHO SHOULD NOT TAKE CELLCEPT?

• You should not use CellCept if you have ever had an allergic reaction to CellCept or any of its ingredients. Please discuss this with your doctor.

WHAT ADDITIONAL INFORMATION SHOULD I KNOW ABOUT CELLCEPT?

• People taking high doses of CellCept each day may have a decrease in blood counts, including white blood cells, red blood cells and platelets.

  Your doctor will do blood tests before you start taking CellCept and during therapy with CellCept to check your blood cell counts.

  Tell your doctor right away if you have any signs of infection, or any unexpected bruising or bleeding, unusual tiredness, lack of energy, dizziness or fainting.

• Cases of bleeding in the stomach or intestines that required hospitalization have been reported. Early signs of bleeding may include stomach pain, blood in your stool, or dark, sticky stools. Tell your doctor if you have any digestive problems, such as ulcers.

• People taking CellCept should not take live vaccines. Some vaccines may not work as well during treatment with CellCept.

• Tell your doctor about all the medicines you are taking including prescription and nonprescription medicines, vitamins and herbal supplements.

• Tell your doctor if you have phenylketonuria (PKU). CellCept Oral Suspension contains aspartame (a source of phenylalanine).

WHAT ARE THE MOST COMMON SIDE EFFECTS FROM CELLCEPT?

• The most common side effects include: diarrhea, vomiting, pain, stomach area pain, swelling of the lower legs, ankles and feet, and high blood pressure.

  These are not all of the possible side effects of CellCept. Tell your doctor about any side effect that bothers you or that does not go away.

This important safety information does not take the place of talking with your doctor about your medical condition or your treatment. Talk with your doctor if you have any questions about your health problems or treatment.