Roxadustat
Pronunciation: rox-a-DUE-stat.
- Generic name
- roxadustat
- Drug class
- Hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor
- Form
- Film-coated tablet (20 mg, 50 mg, 70 mg, 100 mg, 150 mg)
- Route
- Oral
- Legal status
- Prescription-only
Availability and supply rules vary by country
Trade names by country: United Kingdom
Australia: · Full directory
What roxadustat is and how it works
Roxadustat is an oral medicine used to treat symptomatic anaemia (low red blood cell count) caused by chronic kidney disease (CKD) in adults, taken by mouth three times a week (not on consecutive days). (2) (3)
Roxadustat works by helping the body respond as if oxygen levels were low, which stimulates the body's own production of red blood cells. It is started and monitored by a clinician experienced in managing anaemia, with your exact dose based on your body weight, whether you are new to this type of treatment or switching from another anaemia medicine, and regular haemoglobin checks. It carries a genuine, important risk of blood clots (thrombosis), among other risks, so treatment needs close clinical supervision.
Mechanism of action: how roxadustat works
Roxadustat inhibits hypoxia-inducible factor prolyl hydroxylase (HIF-PH) enzymes, stabilising HIF and mimicking a physiological low-oxygen response. This stimulates endogenous erythropoietin production, improves iron availability, and increases red blood cell production. (2) (3)
What roxadustat is used for
Anaemia of chronic kidney disease
Used to treat symptomatic anaemia associated with chronic kidney disease in adults, whether or not they are on dialysis. (2) (3)
Before taking roxadustat
Do not take / not appropriate for
- Do not take roxadustat if you have had a serious allergic reaction to it, or to peanut or soya (the tablets contain peanut/soya-derived excipients). (all countries where authorised) (2) (3)
- Do not take roxadustat during the third trimester of pregnancy or while breastfeeding. (all countries where authorised) (2) (3)
Tell your clinician about
- Any personal or family history of blood clots (deep vein thrombosis, pulmonary embolism, stroke), or obesity, since these raise clotting risk further.
- Any history of seizures.
- Any liver problems -- your starting dose may need to be reduced or the medicine avoided.
- All other medicines, especially phosphate binders, statins, gemfibrozil, or probenecid, which can interact with roxadustat.
- Pregnancy, plans for pregnancy, or breastfeeding.
- Where you live and whether roxadustat is authorised and available there -- its regulatory status differs significantly between countries.
How to take roxadustat
- Take by mouth three times a week, on non-consecutive days (for example Monday/Wednesday/Friday) -- not every day.
- Started and monitored by a clinician experienced in managing anaemia.
- Take phosphate binders or other multivalent-mineral supplements at least 1 hour after roxadustat, since taking them together reduces how much roxadustat your body absorbs.
- Your clinician will check your haemoglobin regularly and adjust your dose to keep it in a target range -- do not change your dose yourself.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)
Missed dose
Contact your prescriber or renal/anaemia care team for guidance if you miss a dose, since roxadustat is dosed on specific non-consecutive days each week and timing matters for both effectiveness and safety monitoring.
Overdose
Seek urgent medical attention if you think you have taken too much roxadustat, or if you develop symptoms of a possible blood clot (such as leg swelling and pain, chest pain, or sudden shortness of breath) or a seizure. (2)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms.
High blood pressure (hypertension).
What to notice: High blood pressure (hypertension).
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)
Blood clotting at the site where blood is accessed for dialysis (vascular access thrombosis).
What to notice: Blood clotting at the site where blood is accessed for dialysis (vascular access thrombosis).
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)
Diarrhoea and nausea.
What to notice: Diarrhoea and nausea.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)
Swelling of the arms or legs (peripheral oedema).
What to notice: Swelling of the arms or legs (peripheral oedema).
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)
High blood potassium (hyperkalaemia).
What to notice: High blood potassium (hyperkalaemia).
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)
Serious warnings
Signs of a blood clot (thromboembolic event) — emergency
Symptoms: Swelling, pain, warmth, or redness in a leg; sudden chest pain or breathlessness; sudden weakness, numbness, or difficulty speaking (possible signs of a clot in the lungs, legs, or brain).
Action: Seek emergency medical help immediately -- roxadustat carries a genuine, significant risk of blood clots, including at dialysis vascular access sites, and regulators have specifically flagged a possible link to stroke-type clots (cerebral infarction). (2) (3)
Seizure — emergency
Symptoms: Convulsions, sudden loss of consciousness, or unusual jerking movements.
Action: Seek emergency medical help immediately. Seizures have been reported as a common side effect in clinical studies; tell your clinician about any personal history of seizures before starting treatment. (2)
Signs of serious infection — high caution
Symptoms: Fever, chills, cough, or urinary symptoms that are severe or do not improve.
Action: Contact your clinician promptly -- serious infections, including pneumonia, urinary tract infections, and blood infections (sepsis), have been reported. (2)
Signs of an underactive thyroid — high caution
Symptoms: Unusual tiredness, weight gain, feeling cold, or constipation.
Action: Tell your clinician -- roxadustat can cause a reversible underactive thyroid; thyroid function may be checked if these symptoms occur. (2)
Interactions
- Phosphate binders and other multivalent-cation products (such as those containing calcium, iron, magnesium, or aluminium, including sevelamer) can markedly reduce roxadustat absorption if taken together -- roxadustat should be taken at least 1 hour after these. (2)
- Gemfibrozil and probenecid can substantially increase roxadustat levels, which may require closer haemoglobin monitoring and dose adjustment by your clinician. (2)
- Roxadustat can increase blood levels of certain statins (such as simvastatin), so your clinician may monitor for statin side effects or adjust your statin dose. (2)
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Not recommended in the first or second trimester and contraindicated in the third trimester, based on animal studies showing reproductive toxicity. Highly effective contraception is recommended during treatment and for at least 1 week after the last dose. (1) (2) (3) (4) (5) (6)
Breastfeeding
Contraindicated -- breastfeeding should not continue during treatment. (1) (2) (3) (4) (5) (6)
Children
Not established for use in children in the sources reviewed for this dossier; discuss with a paediatric specialist if relevant. (1) (2) (3) (4) (5) (6)
Elderly
No specific dose adjustment is described in the sources reviewed based on age alone, but overall clotting and cardiovascular risk should be considered individually. (1) (2) (3) (4) (5) (6)
Hepatic_impairment
Starting dose reduced by 50% in moderate hepatic impairment; not recommended in severe hepatic impairment. (1) (2) (3) (4) (5) (6)
Renal_impairment
This medicine is specifically used for anaemia caused by chronic kidney disease, in people both on and not on dialysis; dosing and monitoring are individualised to kidney status. (1) (2) (3) (4) (5) (6)
Source_ids
Monitoring
Before starting
- Baseline haemoglobin
- Iron status
- Blood pressure
- Personal/family history of blood clots or seizures
- Liver function
During treatment
- Haemoglobin checked every 2 weeks initially, then every 4 weeks once stable, to guide dose adjustments and avoid too rapid a rise.
- Blood pressure monitoring.
- Thyroid function tests if symptoms suggest an underactive thyroid.
- Prompt review if no meaningful improvement in haemoglobin after 24 weeks of treatment, to look for another cause before any change in treatment.
Storage
Store according to the packaging instructions, typically below 30C, in the original packaging to protect from moisture, and out of the reach of children.
Professional information
Clinician-facing context only, sourced from the current UK SmPC and EU EPAR; verify against the current full label before prescribing, and confirm local regulatory status, since roxadustat is not authorised in several major markets.
United Kingdom / European Union
Indication: Symptomatic anaemia of CKD (dialysis and non-dialysis)
Dose summary: Oral, 3x weekly on non-consecutive days. ESA-naive: 70 mg (<100 kg) or 100 mg (>=100 kg). ESA-converting: dose per prior ESA dose (range 70-200 mg). Maintenance 20-400 mg 3x weekly, titrated to Hb 10-12 g/dL (max 300 mg non-dialysis, 400 mg dialysis). Discontinue consideration after 24 weeks without meaningful Hb response, once alternative causes are excluded.
Renal context: Indicated across the CKD anaemia spectrum including dialysis-dependent and non-dialysis-dependent patients; no separate renal dose adjustment beyond the standard weight/ESA-status-based titration described in the SmPC. (2)
Hepatic guidance
Starting dose reduced by 50% in moderate hepatic impairment; not recommended in severe hepatic impairment.
Overdose note
Manage with supportive care and close monitoring for excessive haemoglobin rise, thrombotic events, and seizures; no specific antidote is described in the sources reviewed. (2) (3)
Frequently asked questions
Is roxadustat (Evrenzo) available in the US, UK, Europe, Canada, Australia, and New Zealand?
Roxadustat has a genuinely mixed international regulatory picture. It is authorised in the United Kingdom and the European Union. It is NOT approved in the United States -- the FDA issued a Complete Response Letter in 2021 citing thrombotic and cardiovascular safety concerns, its advisory committee voted against approval, and a live check of the FDA's DailyMed database still returns no results. It is also NOT currently authorised in Canada (a Notice of Non-Compliance was issued and the submission was later cancelled) or in Australia (no TGA/ARTG record could be found). Its current availability in New Zealand could not be confirmed from official sources. (1) (2) (3) (4) (5) (6)
Why is blood clot risk such an important concern with roxadustat?
Clinical trials and regulatory review identified an increased risk of blood clots (including at dialysis vascular access sites, and possibly affecting the brain) with roxadustat. This safety signal was central to the FDA declining US approval and is why European regulators continue to monitor it closely, including a possible link to cerebral infarction (a type of stroke) flagged by the EU's Pharmacovigilance Risk Assessment Committee. (2) (3) (1)
Can I take roxadustat with my phosphate binder medicine?
Not at the same time. Phosphate binders and similar multivalent-cation products (such as sevelamer) can reduce roxadustat absorption by up to two-thirds. Take roxadustat at least an hour before these medicines, and check the exact timing with your pharmacist or kidney care team. (2)
What is the mechanism of action of roxadustat?
Roxadustat inhibits hypoxia-inducible factor prolyl hydroxylase (HIF-PH) enzymes, stabilising HIF and mimicking a physiological low-oxygen response. This stimulates endogenous erythropoietin production, improves iron availability, and increases red blood cell production. (2) (3)
What is the generic name of Roxadustat?
The generic name is roxadustat. (2)
What class of drug is roxadustat?
Roxadustat is classed as: Hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor. (2)
References
- DailyMed search for 'roxadustat' -- zero drug labels foundU.S. Food and Drug Administration / DailyMed (NIH) · United States · accessed 2026-07-30 · source 1
- Evrenzo 150 mg film-coated tablets -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- Astellas Pharma Ltd · United Kingdom · accessed 2026-07-30 · source 2
- Evrenzo (roxadustat) -- EPAR medicine overviewEuropean Medicines Agency (EMA) -- European Public Assessment Report (EPAR) · European Union · accessed 2026-07-30 · source 3
- Regulatory Decision Summary for Roxadustat (Hifrenzo)Health Canada / Drug and Health Products Portal -- Regulatory Decision Summary · Canada · accessed 2026-07-30 · source 4
- TGA eBS PICMI search for 'roxadustat' -- zero documents foundTherapeutic Goods Administration (TGA), Australia -- eBS/PICMI public product search · Australia · accessed 2026-07-30 · source 5
- No Medsafe data sheet or product listing located for roxadustat/EvrenzoMedsafe (New Zealand regulator) -- no data sheet located · New Zealand · accessed 2026-07-30 · source 6
Brand names by country
Single-ingredient roxadustat names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United Kingdom
- Evrenzo (2)MHRA licensed emc smpc confirmed · 20 mg, 50 mg, 70 mg, 100 mg, 150 mg · Astellas Pharma Ltd
View brands in additional countries.
European Union
Evrenzo (3)