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Click here for Complete Prescribing Information.
CellCept® (mycophenolate mofetil) is a medication given to people who have received kidney, heart or liver transplants to help keep their new organ(s) healthy. It does this by helping prevent the body’s defense system (the immune system) from perceiving the new organ as a “foreign” threat and attacking it (a process called “rejection”).
CellCept, an immunosuppressant medication, has been prescribed to help prevent rejection of your transplanted organ. CellCept is taken with other anti-rejection drugs. Please follow your doctor’s instructions for taking your medications.
Important Safety Information:
WARNING:
The use of CellCept in combination with other anti-rejection medications may result in an increased susceptibility to infection and the possible development of lymphomas. Contact your doctor right away if you notice any signs of infection (such as fever, tiredness, headache, redness of skin/wound or enlarged glands).
Female patients of childbearing potential must use contraception. Use of CellCept during pregnancy is associated with increased risk of miscarriage and congenital malformations (birth defects).
- The most common side effects of CellCept include: diarrhea, leukopenia (a decrease in white blood cells), sepsis (an infection in the blood), vomiting and a higher incidence of certain infections. People taking CellCept in combination with other anti-rejection medications have a greater chance of developing lymphomas and other cancers, especially skin cancer.
- If you are a woman of childbearing age, you must use 2 highly effective methods of contraception 4 weeks prior to starting CellCept therapy, and continue contraception until 6 weeks after stopping CellCept treatment, unless abstinence is the chosen method. A patient who is planning a pregnancy should not use CellCept unless she cannot be successfully treated with other immunosuppressant drugs. If you are considering pregnancy, be sure to talk to your doctor.
- Cases of progressive multifocal leukoencephalopathy (PML), an infection of the brain that is sometimes fatal, have been reported in patients treated with CellCept. The reported cases generally had risk factors for PML, including treatment with immunosuppressant therapies. The most common symptoms may include: clumsiness, progressive weakness, loss of motor function in one side of the body, and changes in vision, speech or personality.
- Severe neutropenia (a decrease in neutrophils, a type of white blood cell) has been reported in up to 2% of kidney, 2.8% of heart, and 3.6% of liver transplant patients receiving CellCept at a dose of 3 grams daily.
- Gastrointestinal bleeding (requiring hospitalization) has been observed in approximately 3% of kidney, 1.7% of heart, and 5.4% of liver transplant patients treated with CellCept at a dose of 3 grams daily.
Please be sure to consult with your doctor if you have any questions about your condition or treatment.
For additional safety information, please see complete Prescribing Information.
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