Mycophenolate Mofetil

Brand Name

CellCept®

Company

Roche Laboratories

Class

• Immunosuppressive antimetabolite

Mechanism of Action

• Selectively inhibits inosine monophosphate dehydrogenase in the de novo pathway of purine synthesis, producing potent cytostatic effects on T and B lymphocytes

Indication

• Prophylaxis of graft rejection in patients receiving renal and cardiac allogeneic transplantation

Contraindication

• Hypersensitivity to mycophenolate mofetil, mycophenolic acid or any components of the drug

Warnings

• Increased susceptibility to infection and lymphoma

• Adverse effects on fetal development have been observed in pregnant rats and rabbits—mycophenolate mofetil should not be used in pregnant women and contraception should be used during therapy

• Neutropenia has been observed

Special Precaution

• Gastrointestinal hemorrhage may occur

• Patients with renal impairment have shown higher MPA and MPAG AUCs than normal volunteers

• Should not be used in conjunction with azathioprine

• Repeated laboratory monitoring is required

• Pregnancy Category C

Adverse Reactions

• Diarrhea • Sepsis • Leukopenia • Vomiting

• Antacids with magnesium and aluminum hydroxides

• Cholestyramine

• Drugs that alter gastrointestinal flora may interact with mycophenolate mofetil by disrupting enterohepatic recirculation

• Probenecid

Formulation

• 250 mg capsules supplied in bottles of 100 and 500

• 500 mg tablets in bottles of 100 and 500

• CellCept intravenous: 20 ml, sterile vial containing 500 mg mycophenolate mofetil

Dosage

• 1.0 g twice a day used in combination with corticosteroids and cyclosporine

• Initial dose should be given within 72 hours following transplantation

Editors' Notes:

Mycophenolate mofetil reduces the risk of first acute rejection by 50%. Toxicity is minor, but includes bone marrow suppression and gastrointestinal complaints. A higher incidence of CMV disease compared to azathioprine control was observed in the clinical trials. The efficacy of the long-term use of mycophenolate mofetil has not been established.

The metabolism of mycophenolate is altered by coadministration with cyclosporine. Mycophenolic acid (MPA) levels are lower when mycophenolate mofetil is compared with cyclosporine. Lower doses should be considered in recipients receiving tacrolimus or steroids alone without a calcineurin inhibitor.

Appendix I

Prednisone

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