Epoetin Alfa/Beta/Zeta (ESA)

INDICATION (§4.1, verbatim): 'EPREX is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF): • in adults and paediatrics aged 1 to 18 years on haemodialysis and adult patients on peritoneal dialysis. • in adults with renal insufficiency not yet undergoing dialysis for the treatment of severe anaemia of renal origin accompanied by clinical symptoms in patients.' That is this page's primary identity — an erythropoiesis-stimulating agent for renal anaemia — so the regimen above is this page's own indication. ⚠️ PRODUCT SCOPE — READ BEFORE USING THESE NUMBERS: this page is titled 'Epoetin Alfa/Beta/Zeta (ESA)', but the only label in the bundle is the UK SPC for Eprex 10000 IU/ml solution for injection in pre-filled syringe, i.e. epoetin ALFA, the first brand named on the page. Epoetin beta (NeoRecormon) and epoetin zeta (Retacrit) have their own SPCs, which were NOT fetched; their starting doses and schedules have not been checked and must not be assumed to match. Prescribe from the SPC of the product actually in use. §4.4 also requires that 'the name and the batch number of the administered product should be clearly recorded' for traceability. ⚠️ WEEKLY TOTAL vs PER-DOSE: the haemodialysis maintenance figure is 'The recommended total weekly dose is between 75 IU/kg and 300 IU/kg' — a whole-week total. Reading 300 IU/kg as a three-times-weekly dose triples it. BEFORE STARTING AND BEFORE ANY DOSE INCREASE (§4.2/§4.4): 'All other causes of anaemia (iron, folate or Vitamin B12 deficiency, aluminium intoxication, infection or inflammation, blood loss, haemolysis and bone marrow fibrosis of any origin) should be evaluated and treated'; assure adequate iron stores and supplement — for chronic renal failure patients 'iron supplementation is recommended if serum ferritin levels are below 100 ng/mL'. HAEMOGLOBIN TARGET AND DOSE REDUCTION (adults): target 10–12 g/dL (6.2–7.5 mmol/L); do not raise haemoglobin above 12 g/dL and avoid a rise of more than 2 g/dL over four weeks. 'If the haemoglobin is rising by more than 2 g/dL (1.25 mmol/L) per month, or if the sustained haemoglobin exceeds 12 g/dL (7.5 mmol/L) reduce the EPREX dose by 25%. If the haemoglobin exceeds 13 g/dL (8.1 mmol/L), discontinue therapy until it falls below 12 g/dL (7.5 mmol/L) and then reinstitute EPREX therapy at a dose 25% below the previous dose.' Use the lowest approved effective dose, and exercise caution when escalating ESA doses in chronic renal failure — 'In patients with a poor haemoglobin response to ESA, alternative explanations for the poor response should be considered.' Patients with very low initial haemoglobin (<6 g/dL) may need higher maintenance doses than those starting above 8 g/dL. Each has its own targets and stopping rules — do not carry any of these figures into renal anaemia. Some sections of the product information we used were incomplete — check the full SPC.

THIS IS THE LABEL'S OWN PAEDIATRIC FIGURE, NOT A SCALED ADULT DOSE. §4.2, Paediatric population, correction phase, verbatim: 'The starting dose is 50 IU/kg intravenously, 3 times per week. If necessary, increase or decrease the dose by 25 IU/kg (3 times per week) until the desired haemoglobin concentration range of between 9.5 g/dL to 11 g/dL (5.9 to 6.8 mmol/L) is achieved (this should be done in steps of at least four weeks).' PRODUCT SCOPE: this is the EPOETIN ALFA (Eprex) paediatric regimen only — epoetin beta and epoetin zeta have separate SPCs, were not fetched, and this figure must not be transposed to them. INDICATION AND AGE: §4.1 licenses paediatric use only for symptomatic anaemia of chronic renal failure in patients aged 1 to 18 years ON HAEMODIALYSIS. PAEDIATRIC HAEMOGLOBIN TARGET is 9.5–11 g/dL — lower than the adult 10–12 g/dL; do not raise haemoglobin above 11 g/dL and avoid a rise of more than 2 g/dL over four weeks. MAINTENANCE: the SPC states no paediatric maintenance number — only 'Generally, children under 30 kg require higher maintenance doses than children over 30 kg and adults', and that children with a very low initial haemoglobin (<6.8 g/dL) may require higher maintenance doses; titrate to the target range. NOT ESTABLISHED IN CHILDREN, no posology can be recommended: anaemia of chronic renal failure before initiation of dialysis or on peritoneal dialysis; chemotherapy-induced anaemia; autologous predonation programmes; major elective orthopaedic surgery. No volume is calculated here (concentration deliberately left null) because Eprex is supplied in several strengths and the fetched presentation is one of them — read the strength off the syringe in use, and note §4.2: 'the product is for single use only. Only one dose of EPREX from each syringe should be taken.' Verify all paediatric dosing against a children's formulary and specialist advice before prescribing.