Epoetin alfa is used in the treatment of anaemia associated with chronic renal failure (CRF), cancer chemotherapy, autologous blood donation, and during major elective orthopaedic surgery. Cases of pure red blood cell aplasia (PRCA) have been reported in CRF patients treated with epoetin alfa (Eprex) in Canada as well as in UK. Typically, following months to years of initiation therapy, patients developed sudden worsening of anaemia unresponsive to increasing doses of epoetin alfa or any other erythropoietin and became transfusion dependent. Physicians are therefore advised to monitor clinical response to epoetin alfa. In patients developing sudden lack of efficacy or worsening of anaemia, typical causes of non-response (e.g., iron, folate and vitamin B12 deficiency, aluminium intoxication, infection or inflammation, blood loss and haemolysis) should be investigated. If PRCA is suspected and no cause can be identified, testing for erythropoietin antibodies should be considered and therapy with epoetin alfa must be discontinued immediately. Patients should not be switched to another erythropoietin, other causes of PRCA should be excluded, and appropriate therapy should be instituted. Janssen.Ortho Inc., the manufacturer of epoetin alfa (Eprex) has issued a ‘Dear Healthcare Professional’ letter reflecting this updated safety information. The Summary of Product Characteristics (SPC) has been revised to include relevant warnings, precautions and adverse reaction statements.

Reports In WHO-file: pure red cell aplasia 11

Reference:

1. Media Release, 19 Nov 2001.

Available from URL: http://www.mca.gov.uk

2. ‘Dear Healthcare Professional’ letter by Janssen-Ortho Inc. and Ortho Biotech., 26 Nov 2001.

Available from URL: http://www.hc-sc.gc.ca