Safety advice on particular drugs or classes of drugs
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| Singapore: Contraindication of subcutaneous administration of Eprex® (epoetin alfa) in Singapore in chronic kidney disease patients |
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The Health Sciences Authority (HSA) would like to update healthcare professionals that subcutaneous (SC) administration of Eprex® (epoetin alfa, Johnson & Johnson Pte Ltd) is contraindicated in Singapore in chronic kidney disease (CKD) patients, including end stage renal disease (ESRD) patients. This is due to the strong association of antibody-mediated pure red cell aplasia (Ab-mediated PRCA) with SC administration of Eprex® observed locally. This decision arose from HSA's benefit-risk assessment and its consultation with a local expert panel, comprising renal physicians and haematologists, who assessed that the benefit-risk profile of Eprex® when administered subcutaneously was no longer favourable for CKD patients in the Singapore context.
HSA is working with the company to strengthen the local package inserts to reflect the contraindication of the SC administration route of Eprex® in CKD patients. This contraindication does not apply to Eprex® administered intravenously, Eprex® administered subcutaneously for other approved indications, or other erythropoiesis stimulating agents approved for SC administration in CKD patients.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/publish/hsaportal/../contraindication_of.html
In Hong Kong, there are 13 registered pharmaceutical products containing epoetin alfa. All of the products are prescription-only medicines. Related news has been released by HSA and was posted on the Drug Office website on 22 June, 30 August and 4 October 2013. In view of HSA’s recommendation, a letter to inform healthcare professionals was issued on 4 October 2013 and the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Saturday, January 4, 2014
Issued at HKT 14:30
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