roxadustat
Evrenzo · ATC code B03XA05
Also known as: Roksadustat
- Key facts
- Active substance
- roxadustat
- ATC code
- B03XA05
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Evrenzo 20 mg film-coated tablets / Evrenzo 50 mg film-coated tablets / Evrenzo 70 mg film-coated tablets
- Marketing authorisation holder
- Astellas Pharma Europe B.V.
- Information as of
- 2026-10-28
Key facts
Roxadustat (Evrenzo) is an oral HIF prolyl hydroxylase inhibitor used to treat symptomatic anaemia associated with chronic kidney disease in adults.
What it is used for
- Treatment of adults with symptomatic anaemia associated with chronic kidney disease (CKD).
- Other causes of anaemia should be evaluated first.
Dosing
- Taken three times per week, not on consecutive days; target Hb 10 to 12 g/dL.
- Not previously on an ESA: starting dose 70 mg three times per week (under 100 kg) or 100 mg three times per week (100 kg and over).
- Converting from an ESA: starting dose based on the average ESA dose in the previous 4 weeks – see the full text.
- Adjust stepwise every 4 weeks (range 20 mg to 400 mg three times per week); if Hb rises by more than 2 g/dL, reduce by one step immediately. Monitor Hb every two weeks until stable, then every 4 weeks.
- Do not continue beyond 24 weeks without a clinically meaningful Hb increase. Ensure adequate iron stores before starting.
- Caution in moderate hepatic impairment; not recommended in severe hepatic impairment.
Contraindications
- Hypersensitivity to the active substance, peanut, soya or any excipient.
- Third trimester of pregnancy.
- Breast-feeding.
Important warnings
- Cardiovascular and mortality risk overall comparable to ESA therapy; convert stable ESA-treated dialysis patients only for a valid clinical reason.
- Thrombotic vascular events, including vascular access thrombosis and deep vein thrombosis.
- Seizures may occur.
- Serious infections, especially sepsis.
Side effects
- Most frequent (≥ 10%): hypertension (13.9%), vascular access thrombosis (12.8%), diarrhoea (11.8%), peripheral oedema (11.7%), hyperkalaemia (10.9%) and nausea (10.2%).
- Most frequent serious reactions: sepsis (3.4%), hyperkalaemia (2.5%), hypertension (1.4%) and deep vein thrombosis (1.2%).
- Others: thrombocytopenia, insomnia, seizures, headache; uncommon cerebral infarction; secondary hypothyroidism (frequency not known).
Interactions
- Phosphate binders and products containing calcium, iron, magnesium or aluminium reduce absorption; take roxadustat at least 1 hour after them (not required for lanthanum carbonate).
- Roxadustat increases levels of statins (e.g. simvastatin) through BCRP/OATP1B1 inhibition.
Pregnancy and breastfeeding
- Contraindicated in the third trimester and during breast-feeding; not recommended in the first and second trimester.
- Discontinue and switch if pregnancy occurs.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- EvrenzoAstellas Pharma Europe B.V. · EMEA/H/C/004871
Source: European Medicines Agency (EMA), product information
Turkey
- ErnevodSABA İLAÇ SAN. VE TİC. A.Ş. · 5 register entries
- EvrenzoASTELLAS PHARMA İLAÇ TİC. VE SAN. A.Ş. · 5 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 3 more European countries
- Iceland
- Evrenzo
- Liechtenstein
- Evrenzo
- Norway
- Evrenzo
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Evrenzo – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/evrenzo-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.