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Association of CellCept (mycophenolate mofetil) with a potential risk of pure red cell aplasia (PRCA) - For Health Professionals

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Contact: Marketed Health Products Directorate (MHPD)

The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from Hoffmann-La Roche Limited.
Contact the company for a copy of any references, attachments or enclosures.

Health Canada Endorsed Important Safety Information on CellCept (mycophenolate mofetil)

June 3, 2009

Dear Health Care Professional,

Subject: Reports of Pure Red Cell Aplasia in Patients Treated with CellCept^® (mycophenolate mofetil)

Hoffmann-La Roche Limited (Roche), in consultation with Health Canada, would like to inform you of important new safety information regarding reports of pure red cell aplasia (PRCA) in patients treated with CellCept^® (mycophenolate mofetil) in combination with other immunosuppressive agents.

CellCept is an immunosuppressive agent indicated for the prophylaxis of acute transplant rejection in adults receiving allogeneic renal, cardiac or hepatic transplants, and in children and adolescents (2-18 years) receiving renal transplants. CellCept should be used concomitantly with cyclosporine and corticosteroids.

PRCA
PRCA is a type of anaemia that develops secondary to failure of erythropoiesis. Erythropoiesis is a process by which red blood cells (RBCs) are produced from immature precursors in the bone marrow. PRCA describes a condition in which RBC precursors in bone marrow are nearly absent, while megakaryocytes and white blood cell precursors are usually present at normal levels. PRCA may be idiopathic or occur as a manifestation of an underlying condition. Approximately 5% of all cases of PRCA are drug induced. Patients with PRCA may present with fatigue, lethargy, and/or abnormal paleness of the skin (pallor). Anaemia is the primary clinical concern in PRCA. The degree of anaemia can range from subclinical to severe. Anaemia in acute self-limited PRCA is barely noticeable; however, profound anaemia can occur in chronic acquired PRCA and in congenital PRCA. Patients with severe anaemia have symptoms and signs of uncompensated anaemia and present with weakness, tachycardia, and dyspnoea.

CellCept and PRCA
As of 24 February 2008, 41 cases of PRCA have been reported in patients receiving CellCept (mycophenolate mofetil) in combination with other immunosuppressive agents (tacrolimus, cyclosporine, corticosteroids, azathioprine, sirolimus and alemtuzumab), and the data related to these case reports have been reviewed by Health Canada. Based on the preclinical in vivo evidence and post-marketing database, a causal contribution of CellCept on PRCA is considered possible in a few cases received. The mechanism for the PRCA is not well understood but may be related to immunosuppression. In some cases, the PRCA was found to be reversible with dose reduction or discontinuation of CellCept. When PRCA occurs in a patient on multiple immunosuppressants the relative contribution of the drugs to PRCA and the prophylaxis of rejection must be considered before a decision is made to discontinue a drug.

The Canadian Product Monograph (CPM) for CellCept has been revised to include the above updated safety information.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any occurrence of serious and/or unexpected adverse reactions in patients receiving CellCept should be reported to Hoffmann-La Roche Limited or Health Canada at the following addresses:

Should you have any questions or require additional information regarding the use of CellCept, please contact the Drug Information Department at Hoffmann-La Roche Limited at 1-888-762-4388 from 8:30 a.m. to 4:30 p.m. Monday to Friday Eastern Standard Time.

original signed by

Lorenzo Biondi,
Vice President, Medical and Regulatory Affairs
Hoffmann-La Roche Limited