Myfortic (mycophenolic acid)

Myfortic (mycophenolic acid)
Audience: Renal, cardiac, and hepatic transplantation healthcare professionals

[Posted 09/03/2009] GlaxoSmithKline notified healthcare professionals that cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with Myfortic. The WARNINGS and ADVERSE REACTIONS sections of the CellCept 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 Myfortic therapy. In transplant patients, however, reduced immunosuppression may place the graft at risk.

[09/03/2009 - Dear Healthcare Professional Letter - GSK]
http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM181308.pdf

[07/10/2009 - Prescribing Information and Medication Guide - GSK]

Related MedWatch Alert:

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

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Myfortic (mycophenolic acid)