The Pharmaceutical Journal
Vol 269 No 7208 p127
27 July 2002

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Advice issued that epoetin alfa should be administered by intravenous injection

Ortho Biotec, manufacturer of epo-etin alfa (Eprex), has advised that the product should be administered intravenously in patients with chronic renal failure where possible.

The advice has been issued because of an increased risk of pure red cell aplasia (PRCA) when the drug is given subcutaneously. Since 1998, there have been 141 reports of suspectd PRCA associated with Eprex worldwide.

However, Roche, manufacturer of epoetin beta (NeoRecormon), says that other erythropoetin products administered subcutaneously are not associated with an increased incidence of PRCA. In the United Kingdom, there have been 15 cases of PRCA associated with Eprex and none with epoetin beta.

"The vast majority of patients in the UK rely on subcutaneous administration rather than IV injections ... patients can continue to receive [epoetin beta] subcutaneously," the company states.

Roche highlights a recent editorial published in The New England Journal of Medicine that suggests the increase in PRCA cases may be linked to a change in the drug's manufacturing process. In 1998, Ortho Biotech changed the way epoetin alfa was formulated in order to comply with new European regulations on the use of stabilisers.

Ortho Biotec says that no single trigger of PRCA has been identified.