Product Description.:
CellCept 500, Roche
tablet , film-coated , lavender , oblong oblong
Black ink
INDICATION
CellCept? (mycophenolate mofetil) 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.
CellCept Intravenous is an alternative dosage form to CellCept capsules, tablets and oral suspension. CellCept Intravenous should be administered within 24 hours following transplantation. CellCept Intravenous can be administered for up to 14 days patients should be switched to oral CellCept as soon as they can tolerate oral medication.
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. Use of CellCept during pregnancy is associated with increased rates of pregnancy loss and congenital malformations.
CONTRAINDICATIONS
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).
WARNINGS
* Patients receiving immunosuppressive regimens involving combinations of drugs, including CellCept, are at increased risk of developing lymphomas and other malignancies, particularly of the skin.
* CellCept has been administered in combination with the following agents in clinical trials: antithymocyte globulin, OKT3, cyclosporine and corticosteroids. The efficacy and safety in combination with other immunosuppressive agents have not been determined.
* Oversuppression of the immune system can increase susceptibility to infection, including opportunistic infections, activation of latent viral infections, fatal infections and sepsis. These include sometimes fatal cases of progressive multifocal leukoencephalopathy (PML) and BK virus-associated nephropathy (BKVAN).
Cases of PML have been reported in patients treated with CellCept. Patients generally had risk factors for PML, including treatment with immunosuppressant therapies and impairment of immune function. Hemiparesis, apathy, confusion, cognitive deficiencies and ataxia were the most frequent clinical features observed. In immunosuppressed patients with neurological symptoms, consider PML in the differential diagnosis and consult with a neurologist as clinically indicated. Consider reducing the amount of immunosuppression and be cognizant of the risk that reduced immunosuppression represents to the graft.
BKVAN is associated with serious outcomes, including deteriorating renal function and renal graft loss. Monitoring may help detect patients at risk for BKVAN. Consider reducing immunosuppression for patients who develop evidence of BKVAN.
* Teratogenic effects: Pregnancy Category D. 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.
* Do not initiate CellCept therapy until a negative pregnancy test report is obtained within 1 week prior to beginning therapy. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus. Encourage women using CellCept at any time during pregnancy to enroll in the National Transplantation Pregnancy Registry.
Women of childbearing potential (including pubertal girls and perimenopausal 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, 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.
* Monitor patients for neutropenia that has been observed most frequently in the period of 31 to 180 days posttransplant. If neutropenia develops [absolute neutrophil count (ANC) <1.3 x 103/?L], interrupt or reduce dosing with CellCept, perform appropriate diagnostic tests and manage pa
