Mycophenolate mofetil: pure red cell aplasia
- Medicines and Healthcare products Regulatory Agency
- 1 July 2009
- Therapeutic area:
- Immunosuppression and transplantation
Healthcare professionals should consider a dose reduction or discontinuation of mycophenolate mofetil if patients develop pure red cell aplasia.
Article date: July 2009
Mycophenolate mofetil (CellCept) is an immunosuppressant indicated in combination with ciclosporin and corticosteroids for prophylaxis of acute transplant rejection in adults receiving allogeneic renal, cardiac or hepatic transplants, and in children and adolescents (age 2–18 years) receiving renal transplants.
Up to April 2009, 41 cases of pure red cell aplasia had been reported worldwide in association with mycophenolate mofetil. Pure red cell aplasia is a type of anaemia in which there is a selective reduction of red blood cell precursors on bone-marrow examination. Some patients were also receiving other medicines that could have contributed to the development of pure red cell aplasia (eg, alemtuzumab, tacrolimus, azathioprine, and co-trimoxazole). In 4 cases dose reduction, and in 12 cases discontinuation, of mycophenolate mofetil led to resolution of the condition. The mechanism by which mycophenolate mofetil may cause pure red cell aplasia is unknown.
Advice for healthcare professionals includes:
- consideration of a dose reduction or discontinuation of mycophenolate mofetil if patients develop pure red cell aplasia - changes to treatment should only be done under specialist supervision to minimise the risk of graft rejection
More information is available in a letter sent to healthcare professionals in June 2009.
Article citation: Drug Safety Update July 2009, vol 2 issue 12: 8.
Published: 1 July 2009
Therapeutic area: Immunosuppression and transplantation