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regorafenib

Stivarga · ATC code L01EX05

Key facts
Active substance
regorafenib
ATC code
L01EX05
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Stivarga 40 mg film-coated tablets.
Marketing authorisation holder
Bayer Pharma AG
Information as of
2026-10-28

Key facts

Regorafenib (Stivarga) is an oral multikinase inhibitor used to treat advanced colorectal cancer, gastrointestinal stromal tumours and hepatocellular carcinoma.

What it is used for

  • Metastatic colorectal cancer in adults previously treated with, or not candidates for, available therapies (fluoropyrimidine chemotherapy, anti-VEGF and anti-EGFR therapy).
  • Unresectable or metastatic gastrointestinal stromal tumours (GIST) after progression on or intolerance to imatinib and sunitinib.
  • Hepatocellular carcinoma previously treated with sorafenib.

Dosing

  • 160 mg (4 tablets of 40 mg) once daily for 3 weeks, followed by 1 week off (a 4-week cycle).
  • Dose changes in 40 mg steps; lowest recommended daily dose 80 mg, maximum 160 mg. For hand-foot skin reaction or liver test increases, reduce or interrupt per a defined scheme (see the full text).
  • Take at the same time each day after a light low-fat meal (less than 30% fat), swallowed whole with water.
  • A missed dose is taken the same day when remembered, but never two doses in one day; no extra tablets after vomiting.
  • No dose adjustment in mild hepatic impairment; for other hepatic and renal impairment, see the full text.

Contraindications

  • Hypersensitivity to the active substance or any excipient.

Important warnings

  • Liver test abnormalities are frequent, with rare severe liver injury including fatal hepatic failure; liver tests before starting, at least every two weeks for the first 2 months, then at least monthly.
  • Haemorrhage, gastrointestinal perforation and fistula; infections.
  • Myocardial ischaemia and infarction: interrupt treatment if they occur.
  • Hypertension and hand-foot skin reaction are frequent and may require dose changes.
  • Higher risk of severe liver injury in Asian patients; mild indirect hyperbilirubinaemia may occur in Gilbert's syndrome.

Side effects

  • Most frequent (≥30%): pain, hand-foot skin reaction, asthenia/fatigue, diarrhoea, decreased appetite, hypertension and infection.
  • Most serious: severe liver injury, haemorrhage, gastrointestinal perforation and infection.

Interactions

  • Avoid strong CYP3A4 inhibitors (e.g. clarithromycin, grapefruit juice, itraconazole, ketoconazole, voriconazole) and strong UGT1A9 inhibitors.
  • Rifampicin reduced regorafenib AUC by approximately 50%; strong CYP3A4 inducers should be avoided.
  • Regorafenib inhibits UGT1A1.

Pregnancy and breastfeeding

  • Use in pregnancy only if clearly necessary; women and men should use contraception until 8 weeks after completing therapy.
  • Breast-feeding must be discontinued during treatment.

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.

Full official text →

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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)

  • StivargaBayer Pharma AG · EMEA/H/C/002573

Source: European Medicines Agency (EMA), product information

Turkey

  • StivargaBAYER TÜRK KİMYA SAN. LTD. ŞTİ. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Stivarga
Liechtenstein
Stivarga
Norway
Stivarga

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

  1. European Medicines Agency. Stivarga – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/stivarga-epar-product-information_en.pdf
  2. 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.