FDA approved Cellcept (mycophenolate mofetil) for Organ Rejection ProphylaxisFDA approved Cellcept to prevent organ rejection in transplant patients.

Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), which inhibits inosine monophosphate dehydrogenase (IMPDH), an enzyme critical for de novo purine synthesis in lymphocytes. This inhibition selectively suppresses T- and B-lymphocyte proliferation, thereby reducing the immune response against the transplanted organ.

Cellcept is indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart, or liver transplants, in combination with other immunosuppressants.

Adult Dosing: - Kidney Transplant: 1 g twice daily, orally or intravenously (IV) over no less than 2 hours. - Heart Transplant: 1.5 g twice daily orally or IV over no less than 2 hours. - Liver Transplant: 1.5 g twice daily orally or 1 g twice daily IV over no less than 2 hours.

Pediatric Dosing (3 months and older): - Kidney Transplant: 600 mg/m² orally twice daily, up to a maximum of 2 g daily. - Heart Transplant: 600 mg/m² orally twice daily (starting dose) up to a maximum of 900 mg/m² twice daily (3 g or 15 mL of oral suspension). - Liver Transplant: 600 mg/m² orally twice daily (starting dose) up to a maximum of 900 mg/m² twice daily (3 g or 15 mL of oral suspension).

IV administration is an alternative when patients cannot tolerate oral medication. Administer within 24 hours following transplantation, until patients can tolerate oral medication, up to 14 days. Reduce or interrupt dosing in the event of neutropenia. See full prescribing information for adjustments for renal impairment and neutropenia, and preparation of oral suspension and IV solution.

Important: Cellcept oral dosage forms (capsules, tablets, or oral suspension) should not be used interchangeably with mycophenolic acid delayed-release tablets because absorption rates are not equivalent. Tablets should not be crushed; capsules should not be opened or crushed. Avoid inhalation or contact of skin/mucous membranes with powder from capsules or oral suspension. Administer on an empty stomach; in stable patients, may be taken with food if necessary. Oral suspension must not be mixed with any liquids prior to administration. IV must be infused over no less than 2 hours; do not administer as a bolus.

Clinical trial data not available in label.

Warnings and contraindications not reported in label.

Cellcept is an antimetabolite immunosuppressant used in combination with other immunosuppressants (e.g., calcineurin inhibitors, corticosteroids) for prophylaxis of organ rejection in kidney, heart, and liver transplant recipients. It is indicated for both adult and pediatric patients 3 months and older. The availability of oral and IV formulations allows flexibility in administration, particularly in the early post-transplant period when patients may not tolerate oral medications. Clinicians should monitor for neutropenia and adjust dosing accordingly.