Important Information about CellCept® (mycophenolate mofetil)
Indications:
CellCept is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. CellCept should be used concomitantly with cyclosporine and corticosteroids.
Contraindications:
Allergic reactions to CellCept have been observed; therefore, CellCept is contraindicated in patients with a hypersensitivity to mycophenolate mofetil, mycophenolic acid or any component of the drug product. CellCept Intravenous is contraindicated in patients who are allergic to Polysorbate 80 (TWEEN).
Important Safety Information:
WARNING:
Immunosuppression may lead to increased susceptibility to infection and 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. Physicians should inform female patients that CellCept use during pregnancy is associated with increased rates of pregnancy loss and congenital malformations.
- Patients receiving immunosuppressive regimens involving combinations of drugs, including CellCept, as part of an immunosuppressive regimen are at increased risk of developing lymphomas and other malignancies, particularly of the skin.
- Oversuppression of the immune system can also increase susceptibility to infection, including opportunistic infections, and sepsis.
- Cases of progressive multifocal leukoencephalopathy (PML), sometimes fatal, have been reported in patients treated with CellCept. Hemiparesis, apathy, confusion, cognitive deficiencies and ataxia were the most frequent clinical features observed. The reported cases generally had risk factors for PML, including treatment with immunosuppressant therapies and impairment of immune function. In immunosuppressed patients, physicians should consider PML in the differential diagnosis in patients reporting neurological symptoms and consultation with a neurologist should be considered as clinically indicated. Consideration should be given to reducing the amount of immunosuppression in patients who develop PML. In transplant patients, physicians should also consider the risk that reduced immunosuppression represents to the graft.
- CellCept can cause fetal harm when administered to a pregnant woman. A patient who is planning a pregnancy should not use CellCept unless she cannot be successfully treated with other immunosuppressant drugs. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
- 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 chosen contraceptive method 4 weeks prior to starting CellCept therapy. She should continue contraceptive use during therapy and for 6 weeks after stopping CellCept. Two reliable forms of contraception must be used simultaneously unless abstinence is the chosen method. Patients should be aware that CellCept reduces blood levels of the hormones in the oral contraceptive pill and could theoretically reduce its effectiveness.
- Severe neutropenia [absolute neutrophil count (ANC) <0.5 x 103/µL] developed in up to 2.0% of renal, up to 2.8% of cardiac, and up to 3.6% of hepatic transplant patients receiving CellCept 3 g daily. Patients receiving CellCept should be monitored for neutropenia. If neutropenia develops (ANC <1.3 x 103/µL), dosing with CellCept should be interrupted or the dose reduced, appropriate diagnostic tests performed, and the patient managed appropriately (see DOSAGE AND ADMINISTRATION).
- Gastrointestinal bleeding (requiring hospitalization) has been observed in approximately 3% of renal, in 1.7% of cardiac, and in 5.4% of hepatic transplant patients treated with CellCept 3 g daily.
- Common adverse events that were reported in >20% of patients in CellCept group in controlled studies in prevention of renal, cardiac or hepatic allograft rejection are listed in Table 8 of the ADVERSE REACTIONS section of the complete Prescribing Information.