The mechanism of action of MPA is multifaceted and includes effects on cellular checkpoints responsible for metabolic programming of lymphocytes. MPA shifts transcriptional activities in lymphocytes from a proliferative state to catabolic processes. In vitro studies suggest that MPA modulates transcriptional activities in human CD4+ T-lymphocytes by suppressing the Akt/mTOR and STAT5 pathways that are relevant to metabolism and survival, leading to an anergic state of T-cells whereby the cells become less responsive to antigenic stimulation. Additionally, MPA enhanced the expression of negative co-stimulators such as CD70, PD-1, CTLA-4, and transcription factor FoxP3 as well as decreased the expression of positive co-stimulators CD27 and CD28.

CELLCEPT is an antimetabolite immunosuppressant 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.

The recommended dosage for adult kidney transplant patients is 1 g twice daily, orally or intravenously (IV) over no less than 2 h. Heart Transplant dosage is 1.5 g twice daily orally or IV, over no less than 2 h; Liver transplant 1.5 g twice daily orally or 1g twice daily IV over no less than 2 h. For pediatric patients: Kidney transplant dosage is 600 mg/m2 orally twice daily, up to 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 Liver Transplant maximum of 900 mg/m2 twice daily (3 g or 15 mL of oral suspension.)

The most common adverse reactions in clinical trials (20 % or greater) include diarrhea, leukopenia, infection, vomiting, and there is evidence of a higher frequency of certain types of infections e.g., opportunistic infection.

Contraindications include Hypersensitivity to mycophenolate mofetil, mycophenolic acid or any component of the drug product and patients allergic to Polysorbate 80 (present in CELLCEPT IV.)

Use of MMF during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations, especially external ear and other facial abnormalities including cleft lip and palate, and anomalies