CellCept (mycophenolate mofetil)

CellCept (mycophenolate mofetil) August 2009

Audience: Renal, cardiac, and hepatic transplantation healthcare professionals
[Posted 08/14/2009] FDA and Roche notified healthcare professionals that cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with CellCept. 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 CellCept therapy. In transplant patients, however, reduced immunosuppression may place the graft at risk.

Información profesional, abrir aquí:
[08/14/2009 - Dear Healthcare Professional Letter - Roche]
http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM177399.pdf

Información para la prescripción, abrir aquí:
[06/18/2009 - CellCept Prescribing Information - Roche]
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s021,050723s019,050758s019,050759s024lbl.pdf