roxadustat: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
roxadustat: clinical details
Prescribing considerations
- Initiation should be supervised by a clinician experienced in managing anaemia.
- Evaluate other causes of anaemia and ensure adequate iron stores before treatment.
- Carefully assess thrombotic and cardiovascular risk, particularly with previous thrombosis, obesity or dialysis vascular access.
- Use caution with seizure disorders and moderate hepatic impairment; use is not recommended in severe hepatic impairment.
Contraindications and cautions
- Hypersensitivity to roxadustat, peanut, soya or another product excipient
- Third trimester of pregnancy
- Breastfeeding
Monitoring
- Haemoglobin and its rate of change
- Iron status and causes of inadequate erythropoietic response
- Blood pressure and potassium
- Evidence of thrombosis, including dialysis vascular-access thrombosis
- Infection or sepsis
- Thyroid function when clinically indicated
- Statin adverse effects when relevant interacting treatment is used
Clinical pharmacology
Roxadustat reversibly inhibits HIF prolyl-hydroxylases, increasing endogenous erythropoietin signalling, regulating iron-transport proteins and reducing hepcidin. It is highly protein-bound, primarily metabolised through CYP2C8 and UGT1A9, and is not significantly removed by haemodialysis.
Formulation and product differences
- The product comprises red film-coated tablets in multiple strengths and unit-dose blister packs.
- Tablets differ in size and shape by strength but must be swallowed whole.
- All strengths contain lactose, soya lecithin and Allura Red AC aluminium lake.
roxadustat preparations and strengths
Tablet
Route: Oral
Strengths: 150 mg
roxadustat interactions
Tell the renal team and pharmacist about prescribed, over-the-counter and complementary products. Important interactions include:
Phosphate binders and calcium, iron, magnesium or aluminium products
These can reduce roxadustat absorption. Take roxadustat at least one hour afterwards; this restriction does not apply to lanthanum.
Gemfibrozil, probenecid and strong CYP2C8 or UGT1A9 modifiers
These may alter roxadustat exposure, requiring closer haemoglobin monitoring and clinical review.
Statins, including simvastatin, atorvastatin and rosuvastatin
Roxadustat can increase statin exposure and adverse-effect risk; statin monitoring and adjustment may be needed.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.