Formulary
Darbepoetin alfa: Indications, Dosing, Side Effects and Interactions
Darbepoetin alfa clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 5 min read
Darbepoetin alfa: Indications, Dosing, Side Effects and Interactions
Darbepoetin 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 dialysis**
- **Adult** (By Subcutaneous Injection, Or By Intravenous Injection): Initially 450 nanograms/kg once weekly, dose to be adjusted according to response by approximately 25% at intervals of at least 4 weeks, maintenance dose to be given once weekly or once every 2 weeks, 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, when changing route give same dose then adjust according to weekly or fortnightly haemoglobin measurements, adjust doses not more frequently than every 2 weeks during maintenance treatment.
**Symptomatic anaemia associated with chronic renal failure in patients not on dialysis**
- **Adult** (By Intravenous Injection): Initially 450 nanograms/kg once weekly, dose to be adjusted according to response by approximately 25% at intervals of at least 4 weeks, maintenance dose given once weekly, 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 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, when changing route give same dose then adjust according to weekly or fortnightly haemoglobin measurements, adjust doses not more frequently than every 2 weeks during maintenance treatment.
**Symptomatic anaemia in adults with non-myeloid malignancies receiving chemotherapy**
- **Adult** (By Subcutaneous Injection): Initially 6.75 micrograms/kg every 3 weeks, alternatively initially 2.25 micrograms/kg once weekly, if response inadequate after 9 weeks further treatment may not be effective; if adequate response obtained then reduce dose by 25-50%, 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 restart at a dose approximately 25% lower than the previous dose. Discontinue approximately 4 weeks after ending chemotherapy.
**Symptomatic anaemia associated with chronic renal failure in patients on dialysis for darbepoetin alfa**
- **Child 11-17 years** (By subcutaneous injection, or by intravenous injection): Initially 450 nanograms/kg once weekly, dose to be adjusted according to response by approximately 25% at intervals of at least 4 weeks, maintenance dose to be given once weekly or once every 2 weeks, 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, when changing route give same dose then adjust according to weekly or fortnightly haemoglobin measurements, adjust doses not more frequently than every 2 weeks during maintenance treatment.
**Symptomatic anaemia associated with chronic renal failure in patients not on dialysis for darbepoetin alfa**
- **Child 11-17 years** (By intravenous injection): Initially 450 nanograms/kg once weekly, dose to be adjusted according to response by approximately 25% at intervals of at least 4 weeks, maintenance dose given once weekly, 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 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, when changing route give same dose then adjust according to weekly or fortnightly haemoglobin measurements, adjust doses not more frequently than every 2 weeks during maintenance treatment.
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. Side-effects For darbepoetin alfa Common or very common Cerebrovascular insufficiency; device thrombosis; hypersensitivity; oedema; rash pustular Frequency not known Bronchospasm
Interactions
**Other interactions (1):**
- However, there is potential for an interaction with substances that are highly bound to red blood cells e.g.
Pregnancy
No evidence of harm in animal studies- manufacturer advises caution.
Breast feeding
Manufacturer advises avoid-no information available.
Hepatic impairment
Manufacturer advises caution (no information available).
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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