Reactions 909 - 6 Jul 2002

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Important safety update for ‘Eprex’ In association with Health Canada, Janssen-Ortho Inc. has issued a ‘Dear Health Professional’ letter providing updated information on worldwide post-marketing reports of pure red cell aplasia (PRCA) in patients treated with epoetin-alfa [‘Eprex’]. The update includes a boxed section advising that epoetin-alfa should be administered by the IV rather than SC route in patients with chronic renal failure. While Janssen-Ortho continues to investigate multiple aspects contributing to antibody formation and PRCA in patients receiving epoetin-alfa, it says the scientific literature to date suggests that all exogenous proteins have the potential to elicit an immune response, particularly when administered SC. Consequently, the company says that epoetin-alfa should be administered by the IV route in patients with chronic renal failure. It also advises physicians to monitor patients for clinical responses to epoetin-alfa and to investigate typical causes of non-response in patients who develop a sudden lack of efficacy or worsening anaemia. If no cause is identified and PRCA is suspected, epoetin-alfa therapy should be discontinued immediately and the company contacted for erythropoietin antibody testing. As of 30 April 2002, Janssen-Ortho Inc. was aware of 124 worldwide post-marketing reports of suspected PRCA in patients with chronic renal failure treated with epoetin-alfa. In 104 of these reports PRCA was confirmed by bone marrow examination, and antibodies to erythropoietin were detected in 63 of 79 patients. The median duration of epoetin-alfa treatment prior to the onset of PRCA was 11 months (range 1–92 months). In Canada, as of 30 April 2002, there had been 27 reports of suspected PRCA, of which 20 contained sufficient data to be included in the company’s analyses. The reported incidence rate of suspected PRCA in Canada was estimated at 19.6 per 100,000 patient-years of epoetin-alfa exposure, compared with a worldwide reporting rate of 7.5 per 100,000 patient-years. The company notes that, since the mid 1990’s, epoetin-alfa has been administered by the SC rather than IV route in patients with chronic renal failure, and that most of the worldwide reports of PRCA related to epoetin-alfa have been associated with SC administration. Using data from Europe and Canada, the estimated reporting incidence of suspected PRCA was 0.66 per 100,000 patient-years for IV administration and 19.57 per 100,000 patient-years for SC administration. Health Canada. Important Drug Safety Update: EPREX (epoetin alfa) - Pure Red Cell Aplasia (PRCA, erythroblastopenia). Internet Document : [4 pages], 25 Jun 800863597 2002. Available from: URL: http://www.hc-sc.gc.ca

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Reactions 6 Jul 2002 No. 909