Contraindication of the Subcutaneous Administration of Eprex® in Chronic Kidney Disease Patients

The Health Sciences Authority (HSA) would like to inform healthcare professionals that the subcutaneous (SC) administration of Eprex® is contraindicated in all chronic kidney disease (CKD) patients including end stage renal disease (ESRD) patients in Singapore. This is due to the strong association of antibody-mediated pure red cell aplasia (PRCA) with SC administration of Eprex® observed locally. The decision arose following HSA's benefit-risk assessment and its consultation with an expert panel, comprising renal physicians and haematologists, who assessed that the benefit-risk profile of Eprex® when administered subcutaneously, is no longer favourable in CKD patients in the Singapore context.Healthcare professionals are advised that CKD patients who are currently receiving SC Eprex® should be reviewed as soon as it is possible so that they can switch to IV Eprex® or consider other therapeutic options. They are also advised to continue to closely monitor their patients for Ab-mediated PRCA when using all erythropoeisis stimulating agents (ESAs) and to remind patients on the importance and use of appropriate travel pack to maintain recommended storage temperatures during the transportation of the ESAs. HSA is working with Janssen to update the local package inserts to reflect the new contraindication. Please refer to the letter for more details.