Hoffmann-La Roche Limited (Roche), in consultation with Health Canada, the Canadian counterpart to the Saudi Food and Drug Authority (SFDA) informed health care professional 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. Note that the CellCept® is registered in Saudi Arabia.

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 is a condition in which a patient develops severe anaemia due to failure of the bone marrow to produce red blood cells and is characterized by a severe and sudden anaemia accompanied by the feeling of tiredness or shortness of breath. You should consult your transplant physician immediately if you are feeling unusually tired or short of breath.

Cases of PRCA have been reported in patients treated with CellCept in combination with other immunosuppressive agents.

The mechanism for mycophenolate mofetil induced PRCA is unknown. 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.

PRCA is usually treated by treating the underlying condition (disease) or discontinuing the drug that causes PRCA.

Actions That Healthcare Professionals Should Follow:

1- In some cases, PRCA was found to be reversible when the dosage of CellCept was reduced or CellCept therapy was discontinued. There may be a risk to the transplanted organ if anti-rejection medications, such as CellCept, are reduced in dosage or discontinued

2- PRCA occurs in patients 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.

Information For Patients Regarding cellcept:

1- Patients taking CellCept and any other prescribed anti-rejection medications should not discontinue or change their medication without discussion with their transplant physician.

2- It is important to carefully read the package insert as this gives details about what information you should tell your doctor.

· Report Adverse Dug Reaction to the SFDA:

The public and health care professionals are strongly encouraged to report adverse drug reaction to the National Pharmacovigilance Center (NPC) by filling the appropriate form on the following link:

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