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U.S. Department of Health and Human Services

Safety

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Myfortic (mycophenolic acid)

Audience: Renal, cardiac, and hepatic transplantation healthcare professionals

[Posted 09/03/2009] Novartis and FDA notified healthcare professionals that cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with mycophenolate mofetil (MMF) in combination with other immunosuppressive agents. MMF is metabolized to mycophenolic acid (MPA), the active ingredient in Myfortic and the active form of the drug. The WARNINGS and ADVERSE REACTIONS sections of the Myfortic Prescribing Information have been revised to reflect this new safety information.

PRCA is a type of anemia in which there is a selective reduction of red blood cell precursors on bone marrow examination. Patients with PRCA may present with fatigue, lethargy, and/or abnormal paleness of the skin (pallor). In some cases, PRCA was found to be reversible with dose reduction or cessation of MMF therapy. In transplant patients, however, reduced immunosuppression may place the graft at risk.

[09/03/2009 - Dear Healthcare Professional Letter - Novartis] 
[07/10/2009 - Prescribing Information and Medication Guide - Novartis]

Related MedWatch Alert:

[08/14/2009 - CellCept (mycophenolate mofetil)]