Epoetin alfa (Eprex®, Janssen-Cilag) is indicated for the treatment of anaemia associated with chronic renal failure (CRF), cancer chemotherapy, autologous blood donation and during major elective orthopaedic surgery.
Pure red cell aplasia (erythroblastopenia) has been reported in CRF patients between 1 - 92 months from the initiation of Eprex® therapy (median onset was 11 months).
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Update on number of PRCA cases
From April 1998 through September 2002, there were 179 cases of PRCA suspected to be associated with Eprex® reported worldwide in CRF patients. Of these, 155 were confirmed by bone marrow biopsy and 112 were anti-erythropoietin antibodies positive. All cases of antibody-positive PRCA had administration of Eprex® by the SC route. The incidence of antibody-positive PRCA for Eprex® is estimated by the company to be rare, occurring at less than 1:1000 patient years.
In Singapore, the Pharmacovigilance (PV) Unit has received 10 local reports of PRCA, 7 of which were suspected to be associated with Eprex® and 3 in which combinations of Eprex® and Recormon® (epoetin beta) were used.
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New labelling amendments
Whilst the company continues in its investigation into the causes of PRCA by Eprex®, all healthcare professionals who are involved in the handling of Eprex® are reminded that proper cold-chain handling of Eprex® is important in ensuring stability of the product and it is advised not to keep Eprex® outside of 2 - 8 degree Celsius for more than one hour.
Please report any cases of PRCA associated with erythropoietin to the Pharmacovigilance (PV) Unit.
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