Formulary
Roxadustat: Indications, Dosing, Side Effects and Interactions
Roxadustat is a hypoxia-inducible factor, prolyl hydroxylase inhibitor (HIF-PHI), which stimulates a coordinated erythropoietic response, thereby increasing...
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Roxadustat: Indications, Dosing, Side Effects and Interactions
Roxadustat is a hypoxia-inducible factor, prolyl hydroxylase inhibitor (HIF-PHI), which stimulates a coordinated erythropoietic response, thereby increasing...
Drug action
Roxadustat is a hypoxia-inducible factor, prolyl hydroxylase inhibitor (HIF-PHI), which stimulates a coordinated erythropoietic response, thereby increasing haemoglobin production and improving iron bioavailability.
Indications and dose
**Symptomatic anaemia associated with chronic kidney disease in patients not currently treated with an erythropoiesis-stimulating agent (initiated by a specialist)**
- **Adult** (By Mouth): (body-weight 100 kg and above) Initially 100 mg 3 times a week, adjusted according to response; usual maintenance 20-400 mg 3 times a week, doses should not be taken on consecutive days, dose adjusted at intervals of 4 weeks to achieve haemoglobin concentration of 10 to 12 g/dL. For dose adjustments and maximum recommended dose-consult product literature, consider discontinuation of treatment if adequate increase in haemoglobin concentration not achieved in 24 weeks.
**Symptomatic anaemia associated with chronic kidney disease in patients currently treated with an erythropoiesis-stimulating agent (initiated by a specialist)**
- **Adult** (By Mouth): (consult product literature).
Cautions
Active infection; history of seizures, epilepsy and other medical conditions associated with a predisposition to seizures; risk factors for venous thromboembolism
Side effects
Common or very common Constipation; diarrhoea; embolism and thrombosis; headache; hyperkalaemia; hypertension; insomnia; nausea; peripheral oedema; seizure; sepsis; vomiting Uncommon Hyperbilirubinaemia Frequency not known Generalised exfoliative dermatitis; increased risk of infection; secondary hypothyroidism
Interactions
**Severe interactions:**
- Staggered administration of phosphate binders (at least 1 hour apart) had no clinically significant effect on roxadustat exposure in patients with CKD.
**Other interactions (18):**
- Effect of other medicinal products on roxadustat Phosphate binders and other products containing multivalent cations Co-administration of roxadustat with phosphate binders sevelamer carbonate or...
- Roxadustat may form a chelate with multivalent cations such as in phosphate binders or other products containing calcium, iron, magnesium or aluminium.
- Roxadustat should be taken at least 1 hour after administration of phosphate binders or other medicinal products or supplements containing multivalent cations (see section 4.2).
- This restriction does not apply to lanthanum carbonate, as the co-administration of roxadustat with lanthanum carbonate did not result in a clinically meaningful change in the plasma exposure of...
- Modifiers of CYP2C8 or UGT1A9 activity Roxadustat is a substrate of CYP2C8 and UGT1A9.
- Co-administration of roxadustat with gemfibrozil (CYP2C8 and OATP1B1inhibitor) or probenecid (UGT and OAT1/OAT3 inhibitor) in healthy subjects increased roxadustat AUC by 2.3-fold and C max by...
Pregnancy
Avoid-toxicity in animal studies. M
Breast feeding
Avoid-present in milk in animal studies. M
Hepatic impairment
Caution in moderate impairment; avoid in severe impairment (no information available). M Dose adjustments Use half the normal starting dose in moderate impairment . M
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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