Formulary
Epoetin beta: Indications, Dosing, Side Effects and Interactions
Epoetin beta clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 8 min read
Epoetin beta: Indications, Dosing, Side Effects and Interactions
Epoetin beta clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Symptomatic anaemia associated with chronic renal failure**
- **Adult** (By Subcutaneous Injection): Initially 20 units/kg 3 times a week for 4 weeks, increased in steps of 20 units/kg 3 times a week, according to response at intervals of 4 weeks, total weekly dose may be divided into daily doses; maintenance dose, initially reduce dose by half then adjust according to response at intervals of 1-2 weeks, total weekly maintenance dose may be given as a single dose or in 3 or 7 divided doses. Subcutaneous route preferred in patients not on haemodialysis. Reduce dose by approximately 25% if rise in haemoglobin concentration exceeds 2 g/100 mL over 4 weeks or if haemoglobin concentration approaches or 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; maximum 720 units/kg per week.
- **Adult** (By Intravenous Injection): Initially 40 units/kg 3 times a week for 4 weeks, then increased to 80 units/kg 3 times a week, then increased in steps of 20 units/kg 3 times a week if required, at intervals of 4 weeks; maintenance dose, initially reduce dose by half then adjust according to response at intervals of 1-2 weeks. Intravenous injection to be administered over 2 minutes. Subcutaneous route preferred in patients not on haemodialysis. Reduce dose by approximately 25% if rise in haemoglobin concentration exceeds 2 g/100 mL over 4 weeks or if haemoglobin concentration approaches or 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; maximum 720 units/kg per week.
**Symptomatic anaemia in adults with non-myeloid malignancies receiving chemotherapy**
- **Adult** (By Subcutaneous Injection): Initially 450 units/kg once weekly for 4 weeks, dose to be given weekly as a single dose or in 3-7 divided doses, increase dose after 4 weeks (if a rise in haemoglobin of at least 1 g/100 mL not achieved), increased to 900 units/kg once weekly, dose to be given weekly as a single dose or in 3-7 divided doses, if adequate response obtained reduce dose by 25-50%, discontinue treatment if haemoglobin concentration does not increase by at least 1 g/100 mL after 8 weeks of therapy (response unlikely). 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; maximum 60 000 units per week.
**To increase yield of autologous blood (to avoid homologous blood) in predonation programme in moderate anaemia when blood-conserving procedures are insufficient or unavailable**
- **Adult** (By Intravenous Injection, Or By Subcutaneous Injection): (consult product literature).
**Symptomatic anaemia associated with chronic renal failure for epoetin beta**
- **Neonate** (By subcutaneous injection): Initially 20 units/kg 3 times a week for 4 weeks, increased in steps of 20 units/kg 3 times a week, according to response at intervals of 4 weeks, total weekly dose may be divided into daily doses; maintenance dose, initially reduce dose by half then adjust according to response at intervals of 1-2 weeks, total weekly maintenance dose may be given as a single dose or in 3 or 7 divided doses. Subcutaneous route preferred in patients not on haemodialysis. Reduce dose by approximately 25% if rise in haemoglobin concentration exceeds 2 g/100 mL over 4 weeks or if haemoglobin concentration approaches or 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; maximum 720 units/kg per week.
- **Child** (By subcutaneous injection): Initially 20 units/kg 3 times a week for 4 weeks, increased in steps of 20 units/kg 3 times a week, according to response at intervals of 4 weeks, total weekly dose may be divided into daily doses; maintenance dose, initially reduce dose by half then adjust according to response at intervals of 1-2 weeks, total weekly maintenance dose may be given as a single dose or in 3 or 7 divided doses. Subcutaneous route preferred in patients not on haemodialysis. Reduce dose by approximately 25% if rise in haemoglobin concentration exceeds 2 g/100 mL over 4 weeks or if haemoglobin concentration approaches or 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; maximum 720 units/kg per week.
- **Neonate** (By intravenous injection): Initially 40 units/kg 3 times a week for 4 weeks, then increased to 80 units/kg 3 times a week, then increased in steps of 20 units/kg 3 times a week if required, at intervals of 4 weeks; maintenance dose, initially reduce dose by half then adjust according to response at intervals of 1-2 weeks. Intravenous injection to be administered over 2 minutes. Subcutaneous route preferred in patients not on haemodialysis. Reduce dose by approximately 25% if rise in haemoglobin concentration exceeds 2 g/100 mL over 4 weeks or if haemoglobin concentration approaches or 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; maximum 720 units/kg per week.
- **Child** (By intravenous injection): Initially 40 units/kg 3 times a week for 4 weeks, then increased to 80 units/kg 3 times a week, then increased in steps of 20 units/kg 3 times a week if required, at intervals of 4 weeks; maintenance dose, initially reduce dose by half then adjust according to response at intervals of 1-2 weeks. Intravenous injection to be administered over 2 minutes. Subcutaneous route preferred in patients not on haemodialysis. Reduce dose by approximately 25% if rise in haemoglobin concentration exceeds 2 g/100 mL over 4 weeks or if haemoglobin concentration approaches or 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; maximum 720 units/kg per week.
**Prevention of anaemias of prematurity in neonates for epoetin beta**
- **Neonate up to 33 weeks corrected gestational age (body-weight 0.75-1.5 kg)** (By subcutaneous injection): 250 units/kg 3 times a week preferably started within 3 days of birth and continued for 6 weeks, using single-dose unpreserved injection.
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)
Contraindications
Pure red cell aplasia following erythropoietin therapy; uncontrolled hypertension
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.
Interactions
**Other interactions (1):**
- Animal experiments revealed that epoetin beta does not increase the myelotoxicity of cytostatic medicinal products like etoposide, cisplatin, cyclophosphamide, and fluorouracil.
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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