Medicines Control Council, National Adverse Drug Monitoring Centre,

South African Medical Journal (SAMJ)

SAMJ FORUM839November 2003, Vol. 93, No. 11  SAMJJanssen-Cilag has revised the prescribing information in thepackage insert for Eprex (recombinant human erythropoietinalfa) to include the following statements:‘In patients with chronic renal failure, Eprex should only beadministered by the intravenous route’, and ‘If PRCA is diagnosed, therapy with Eprex must be immediatelydiscontinued and testing for erythropoietin antibodies should beconsidered. Patients should not be switched to another product asanti-erythopoietin antibodies cross-react with other erythropoietins.Other causes of PRCA should be excluded and appropriate therapyinstituted.’Changes to the prescribing information for Eprex have beenmade as a result of investigations into cases of pure red cellaplasia (PRCA), erythroblastopenia) associated with the use oferythropoietin. In patients with chronic renal failure Eprexshould only be administered by the intravenous route.International statisticsCases of antibody-positive PRCA have been reported frompost-marketing experience in patients with chronic renal failure(CRF). As of 30 September 2002, the company had received 155reports of PRCA confirmed by bone marrow biopsyworldwide. All cases were limited to patients with chronicrenal failure. Of these cases 112 tested positive for the presenceof antierythropoietin antibodies, and in the remaining 43 cases,the antibody status was unknown. All patients withantierythropoietin antibodies had received Eprex via thesubcutaneous route of administration, where the route ofadministration was known. Lack of efficacy was first notedbetween 4 and 24 months after the start of treatment withEprex, in those patients who tested positive forantierythropoietin antibodies. In addition, there has been areport of PRCA in a patient who received repeated doses ofEprex subcutaneously for refractory anaemia in an unlicensedindication.Of the total number of cases reported to date, there has beena subset of antibody-mediated PRCA cases (17/112) in patientsexposed to other erythropoietin products in conjunction withEprex. Janssen-Cilag has embarked on an extensiveepidemiological study as part of the clinical programme tomonitor and evaluate the occurrence of antibody-mediatedPRCA associated with epoetinums in patients with chronicrenal failure.National statisticsThe National Adverse Drug Event Monitoring Centre of theMedicines Control Council has 5 reports of lack of efficacyassociated with the use of Eprex. All the patients had CRF andwere being treated with subcutaneous Eprex. The details areset out below.RecommendationIt is recommended that clinicians review the management ofpatients with chronic renal failure being treated with Eprex.Eprex administration may be continued in these patients, butonly via the intravenous route. When changing fromsubcutaneous to intravenous administration, the same dose ofEprex should be used and the haemoglobin monitoredcarefully (e.g. weekly) so that appropriate changes to the dosecan be made to keep the haemoglobin within the target range.National Adverse Drug Event Monitoring CentreMedicines Control Council1. ADRI database, National Adverse Drug Event Monitoring Centre, Medicines ControlCouncil.2. Eprex package insert.DRUG ALERTEprex (recombinant human erythropoietin alfa) and pure redcell aplasia — recommendations for administration topatients with CRFAnti-Bone marrow erythropoietinPatient aspirate antibodies Outcome1 Positive Positive Died due to disease progression2 Positive Negative Unknown3 Not done Not done Recovered from septicaemia4 Not done Not done Unknown — awaitingfeedback fromreporter5 Positive Positive UnknownForum Nov  11/6/03  11:52 AM  Page 839

Drug Alert: Eprex (recombinant human erythropoeitin alfa) and pure red cell aplasia - recommendations for administration to patients with CRF

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Drug Alert: Eprex (recombinant human erythropoeitin alfa) and pure red cell aplasia - recommendations for administration to patients with CRF

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