Formulary
Epoetin alfa: Indications, Dosing, Side Effects and Interactions
Epoetin alfa clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 8 min read
Epoetin alfa: Indications, Dosing, Side Effects and Interactions
Epoetin alfa clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Symptomatic anaemia associated with chronic renal failure in patients on haemodialysis**
- **Adult** (By Intravenous Injection, Or By Subcutaneous Injection): Initially 50 units/kg 3 times a week, adjusted in steps of 25 units/kg 3 times a week, dose adjusted according to response at intervals of at least 4 weeks; maintenance 75-300 units/kg once weekly, intravenous route preferred, intravenous injection to be given over 1-5 minutes, subcutaneous injection, maximum 1 mL per injection site, maintenance dose can be given as a single dose or in divided doses, reduce dose by approximately 25% if rise in haemoglobin concentration exceeds 2 g/100 mL over 4 weeks or if haemoglobin concentration exceeds 12 g/100 mL; if haemoglobin concentration continues to rise, despite dose reduction, suspend treatment until haemoglobin concentration decreases and then restart at a dose approximately 25% lower than the previous dose.
**Symptomatic anaemia associated with chronic renal failure in adults on peritoneal dialysis**
- **Adult** (By Intravenous Injection, Or By Subcutaneous Injection): Initially 50 units/kg twice weekly; maintenance 25-50 units/kg twice weekly, intravenous route preferred, intravenous injection to be given over 1-5 minutes, subcutaneous injection, maximum 1 mL per injection site, reduce dose by approximately 25% if rise in haemoglobin concentration exceeds 2 g/100 mL over 4 weeks or if haemoglobin concentration exceeds 12 g/100 mL; if haemoglobin concentration continues to rise, despite dose reduction, suspend treatment until haemoglobin concentration decreases and then restart at a dose approximately 25% lower than the previous dose.
**Severe symptomatic anaemia of renal origin in adults with renal insufficiency not yet on dialysis**
- **Adult** (By Intravenous Injection, Or By Subcutaneous Injection): Initially 50 units/kg 3 times a week, increased in steps of 25 units/kg 3 times a week, adjusted according to response, dose to be increased at intervals of at least 4 weeks; maintenance 17-33 units/kg 3 times a week (max. per dose 200 units/kg 3 times a week), intravenous route preferred, intravenous injection to be given over 1-5 minutes, subcutaneous injection, maximum 1 mL per injection site, reduce dose by approximately 25% if rise in haemoglobin concentration exceeds 2 g/100 mL over 4 weeks or if haemoglobin concentration exceeds 12 g/100 mL; if haemoglobin concentration continues to rise, despite dose reduction, suspend treatment until haemoglobin concentration decreases and then restart at a dose approximately 25% lower than the previous dose.
**Symptomatic anaemia in adults receiving cancer chemotherapy**
- **Adult** (By Subcutaneous Injection): Initially 150 units/kg 3 times a week, alternatively initially 450 units/kg once weekly, increased to 300 units/kg 3 times a week, increased if appropriate rise in haemoglobin (or reticulocyte count) not achieved after 4 weeks; discontinue if inadequate response after 4 weeks at higher dose, subcutaneous injection maximum 1 mL per injection site, reduce dose by approximately 25-50% if rise in haemoglobin concentration exceeds 2 g/100 mL over 4 weeks or if haemoglobin concentration exceeds 12 g/100 mL; if haemoglobin concentration continues to rise, despite dose reduction, suspend treatment until haemoglobin concentration decreases and then restart at a dose approximately 25% lower than the previous dose. Discontinue approximately 4 weeks after ending chemotherapy.
**To increase yield of autologous blood (to avoid homologous blood) in predonation programme in moderate anaemia either when large volume of blood required or when sufficient blood cannot be saved**
- **Adult** (By Intravenous Injection): for elective major surgery 600 units/kg twice weekly for 3 weeks before surgery, consult product literature for details and advice on ensuring high iron stores, intravenous injection to be given over 1-5 minutes.
**Moderate anaemia (haemoglobin concentration 10-13 g/100 mL) before elective orthopaedic surgery in adults with expected moderate blood loss to reduce exposure to allogeneic blood transfusion or if autologous transfusion unavailable**
- **Adult** (By Subcutaneous Injection): 600 units/kg once weekly for 3 weeks before surgery and on day of surgery, alternatively 300 units/kg daily for 15 days starting 10 days before surgery, consult product literature for details, subcutaneous injection maximum 1 mL per injection site.
**Symptomatic anaemia associated with chronic renal failure in patients on haemodialysis for Eprex pre-filled syringes**
- **Child (body-weight up to 10 kg)** (By intravenous injection): Initially 50 units/kg 3 times a week, adjusted in steps of 25 units/kg 3 times a week, dose adjusted according to response at intervals of at least 4 weeks; maintenance 75-150 units/kg 3 times a week, intravenous injection to be given over 1-5 minutes, reduce dose by approximately 25% if rise in haemoglobin concentration exceeds 2 g/100 mL over 4 weeks or if haemoglobin concentration exceeds 12 g/100 mL; if haemoglobin concentration continues to rise, despite dose reduction, suspend treatment until haemoglobin concentration decreases and then restart at a dose approximately 25% lower than the previous dose.
- **Child (body-weight 10-30 kg)** (By intravenous injection): Initially 50 units/kg 3 times a week, adjusted in steps of 25 units/kg 3 times a week, dose adjusted according to response at intervals of at least 4 weeks; maintenance 60-150 units/kg 3 times a week, intravenous injection to be given over 1-5 minutes, reduce dose by approximately 25% if rise in haemoglobin concentration exceeds 2 g/100 mL over 4 weeks or if haemoglobin concentration exceeds 12 g/100 mL; if haemoglobin concentration continues to rise, despite dose reduction, suspend treatment until haemoglobin concentration decreases and then restart at a dose approximately 25% lower than the previous dose.
- **Child (body-weight 31-60 kg)** (By intravenous injection): Initially 50 units/kg 3 times a week, adjusted in steps of 25 units/kg 3 times a week, dose adjusted according to response at intervals of at least 4 weeks; maintenance 30-100 units/kg 3 times a week, intravenous injection to be given over 1-5 minutes, reduce dose by approximately 25% if rise in haemoglobin concentration exceeds 2 g/100 mL over 4 weeks or if haemoglobin concentration exceeds 12 g/100 mL; if haemoglobin concentration continues to rise, despite dose reduction, suspend treatment until haemoglobin concentration decreases and then restart at a dose approximately 25% lower than the previous dose.
- **Child (body-weight 61 kg and above)** (By intravenous injection): Initially 50 units/kg 3 times a week, adjusted in steps of 25 units/kg 3 times a week, dose adjusted according to response at intervals of at least 4 weeks; maintenance 75-300 units/kg once weekly, maintenance dose can be given as a single dose or in divided doses, intravenous injection to be given over 1-5 minutes, reduce dose by approximately 25% if rise in haemoglobin concentration exceeds 2 g/100 mL over 4 weeks or if haemoglobin concentration exceeds 12 g/100 mL; if haemoglobin concentration continues to rise, despite dose reduction, suspend treatment until haemoglobin concentration decreases and then restart at a dose approximately 25% lower than the previous dose.
Cautions
Aluminium toxicity (can impair the response to erythropoietin); concurrent infection (can impair the response to erythropoietin); correct factors that contribute to the anaemia of chronic renal failure, such as iron or folate deficiency, before treatment; during dialysis (increase in heparin or low molecular weight heparin dose may be needed); epilepsy; inadequately treated or poorly controlled blood pressure-interrupt treatment if blood pressure uncontrolled; ischaemic vascular disease; malignant disease; other inflammatory disease (can impair the response to erythropoietin); risk factors for thromboembolism; risk of thrombosis may be increased when used for anaemia in adults receiving cancer chemotherapy; sickle-cell disease (lower target haemoglobin concentration may be appropriate); sudden stabbing migraine-like pain (warning of a hypertensive crisis); thrombocytosis (monitor platelet count for first 8 weeks) Cautions For epoetin alfa Risk of thrombosis may be increased when used for anaemia before orthopaedic surgery-avoid in cardiovascular disease including recent myocardial infarction or cerebrovascular accident
Contraindications
Pure red cell aplasia following erythropoietin therapy; uncontrolled hypertension Contra-indications For epoetin alfa Surgical patients who cannot receive adequate antithrombotic prophylaxis
Side effects
Common or very common Arthralgia; embolism and thrombosis; headache; hypertension (dose-dependent); influenza like illness; peripheral oedema; skin reactions; stroke Uncommon Hypertensive crisis (in isolated patients with normal or low blood pressure); respiratory tract congestion; seizure Rare or very rare Angioedema; thrombocytosis Frequency not known Hypertensive encephalopathy; pure red cell aplasia (more common following subcutaneous administration in patients with chronic renal failure); severe cutaneous adverse reactions (SCARs) Side-effects, further information Hypertensive crisis In isolated patients with normal or low blood pressure, hypertensive crisis with encephalopathy-like symptoms and generalised tonic-clonic seizures requiring immediate medical attention has occurred with epoetin. Pure red cell aplasia There have been very rare reports of pure red cell aplasia in patients treated with erythropoietins. In patients who develop a lack of efficacy with erythropoietin therapy and with a diagnosis of pure red cell aplasia, treatment with erythropoietins must be discontinued and testing for erythropoietin antibodies considered. Patients who develop pure red cell aplasia should not be switched to another form of erythropoietin. Side-effects For epoetin alfa Common or very common Chills; cough; diarrhoea; fever; myalgia; nausea; pain; vomiting Uncommon Hyperkalaemia
Interactions
**Other interactions (1):**
- In female adult patients with metastatic breast cancer, subcutaneous co-administration of 40,000 IU/mL epoetin alfa with trastuzumab 6 mg/kg had no effect on the pharmacokinetics of trastuzumab.
Pregnancy
No evidence of harm. Benefits probably outweigh risk of anaemia and of blood transfusion in pregnancy.
Breast feeding
Unlikely to be present in milk. Minimal effect on infant.
Hepatic impairment
Manufacturer advises caution in chronic hepatic failure.
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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