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 a prodrug of mycophenolic acid, which inhibits inosine monophosphate dehydrogenase, thereby blocking de novo purine synthesis in lymphocytes, leading to suppression of T- and B-cell proliferation.

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.

- **Kidney Transplant:** Adults: 1 g twice daily orally or IV over no less than 2 hours. Pediatrics: 600 mg/m² orally twice daily, up to a maximum of 2 g daily. For BSA ≥1.25 m², capsules/tablets may be used (750 mg twice daily for BSA 1.25 to <1.5 m²; 1 g twice daily for BSA ≥1.5 m²). - **Heart Transplant:** Adults: 1.5 g twice daily orally or IV over no less than 2 hours. Pediatrics: Starting dose 600 mg/m² orally twice daily; may increase to maintenance of 900 mg/m² twice daily (max 3 g or 15 mL oral suspension). - **Liver Transplant:** Adults: 1.5 g twice daily orally or 1 g twice daily IV over no less than 2 hours. Pediatrics: Starting dose 600 mg/m² orally twice daily; may increase to maintenance of 900 mg/m² twice daily (max 3 g or 15 mL oral suspension). - IV formulation is an alternative when patients cannot tolerate oral medication; administer within 24 hours post-transplant, for up to 14 days, over no less than 2 hours. 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.

Trial data not available in label.

- Should not be used without supervision of a physician experienced in immunosuppressive therapy. - Oral dosage forms should not be used interchangeably with mycophenolic acid delayed-release tablets without supervision due to non-equivalent absorption rates. - 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. If contact occurs, wash thoroughly with soap and water; for ocular contact, rinse eyes with plain water. - IV formulation must not be administered as a bolus; infuse over no less than 2 hours to reduce risk of local reactions (phlebitis, thrombosis). - Dose reduction or interruption may be needed for neutropenia.

Cellcept is an immunosuppressant used in combination with other agents for prophylaxis of organ rejection in kidney, heart, and liver transplant recipients, including pediatric patients 3 months and older. It offers an alternative for patients who cannot tolerate oral medication via IV formulation. Clinicians should consider individual patient factors, including renal function and neutropenia risk, when dosing.