Cellcept Safety & Product Information

Important Safety Information

Adverse events reported in >30% of renal, cardiac or liver transplant patients receiving CellCept® (mycophenolate mofetil), in combination with cyclosporine and corticosteroids, were pain, fever, headache, asthenia, anemia, leukopenia,* thrombocytopenia, leukocytosis, urinary tract infection, hypertension, hypotension, peripheral edema, hypercholesteremia, hypokalemia, hyperglycemia, creatinine, BUN and cough increased, hypomagnesemia, diarrhea, constipation, nausea, vomiting, respiratory infection, dyspnea, lung disorder, pleural effusion, tremor and insomnia.

Mycophenolate mofetil (MMF) can cause fetal harm when administered to a pregnant woman. Use of MMF during pregnancy is associated with an increased risk of first trimester pregnancy loss and increased risk of congenital malformation, especially external ear and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus and kidney

Women of childbearing potential (including pubertal girls and peri-menopausal women) taking CellCept must receive contraceptive counseling and use effective contraception. The patient should begin using her two chosen methods of contraception 4 weeks prior to starting CellCept therapy, unless abstinence is the chosen method. She should continue contraceptive use during therapy and for 6 weeks after stopping CellCept. Patient should be aware that CellCept reduces blood levels of the hormones in the oral contraceptive pill and could theoretically reduce its effectiveness.

Oversuppression of the immune system can also increase susceptibility to infection, including opportunistic infections, fatal infections and sepsis.

WARNING: Immunosuppression may lead to increased susceptibility to infection and the possible development of lymphoma. Only physicians experienced in immunosuppressive therapy and management of renal, cardiac or hepatic transplant patients should use CellCept. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.

Female users of childbearing potential must use contraception. Use of CellCept during pregnancy is associated with increased risk of pregnancy loss and congenital malformations.

*Patients should be monitored for neutropenia. Dosing should be interrupted or the dose reduced if neutropenia develops.

For complete product information, click here.