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U.S. Department of Health and Human Services

Drugs

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Risk Evaluation and Mitigation Strategy (REMS) Under Review for CellCept and Myfortic

CellCept (mycophenolate mofetil) and Myfortic (mycophenolic acid) are immunosuppressant drugs approved for the prophylaxis of organ rejection. CellCept was approved on May 3, 1995, and is used for the prophylaxis of organ rejection in patients  receiving allogeneic renal, cardiac, or hepatic transplants.  Myfortic, was approved on February 27, 2004, and is used for prophylaxis of organ rejection in patients receiving allogeneic renal transplant. Generic versions of products containing mycophenolate mofetil have been approved.

In November 2007, the package insert for CellCept and Myfortic was revised to include a Boxed Warning about the increased risk of pregnancy loss and congenital malformations associated with the use of these products during pregnancy.  The congenital malformations include cleft lip and palate and abnormality of the distal limbs, heart, esophagus, and kidney.  On December 15, 2008, the Medication Guide for these products was approved.

Under the Food and Drug Administration Amendments Act of 2007, the FDA can require manufacturers to submit a Risk Evaluation and Mitigation Strategy (REMS) when a drug first comes on the market, or later if FDA becomes aware of new safety data about the drug.  A REMS is a strategy to manage a known or potential serious risk to ensure that the benefits of the drug outweigh its risks.  Generic versions of products are required to have a REMS if the innovator product has an approved REMS.

In September 2008, the FDA required the manufacturers of CellCept and Myfortic to submit a REMS to ensure that the benefits of the drug outweigh the risk of congenital malformations. The REMS will include several components including the approved Medication Guide, elements to assure safe use -- such as physician training and certification, patient education, and a pregnancy registry, an implementation plan, and a timetable for assessment of the REMS.

The full REMS is currently under review by the FDA.  To view the product package inserts for CellCept and Myfortic including the Medication Guides go to Drugs@FDA.

CellCept is marketed by Roche. Myfortic is marketed by Novartis.