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sunitinib

Sutent · ATC code L01EX01

Brand names: Sutent, Sunitinib Bluefish, Sunitinib G.L., Sunitinib Rivopharm, Sunitinib Sandoz, Sunitinib Stada, Sunitinib Teva, Sunitinib Al, Sunitinib Aqvida, Sunitinib Beta, Sunitinib Denk, Sunitinib Heumann, Sunitinib Hexal, Sunitinib Holsten, Sunitinib Koanaa …

Key facts
Active substance
sunitinib
ATC code
L01EX01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Sutent 12.5 mg hard capsules / Sutent 25 mg hard capsules / Sutent 37.5 mg hard capsules
Marketing authorisation holder
Pfizer Limited
Information as of
2026-10-27

Key facts

Sunitinib is an oral multi-targeted tyrosine kinase inhibitor used in adults with gastrointestinal stromal tumour (GIST), metastatic renal cell carcinoma and pancreatic neuroendocrine tumours.

What it is used for

  • Unresectable and/or metastatic GIST after imatinib failure due to resistance or intolerance
  • Advanced/metastatic renal cell carcinoma (MRCC)
  • Unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with progression

Dosing

  • GIST and MRCC: 50 mg once daily for 4 weeks, then a 2-week rest (6-week cycle).
  • pNET: 37.5 mg once daily without a scheduled rest period.
  • Adjust in 12.5 mg steps; GIST/MRCC not above 75 mg nor below 25 mg daily.
  • Avoid potent CYP3A4 inhibitors or inducers; if unavoidable, adjust dose as in the full text.
  • No starting dose adjustment in mild/moderate hepatic or renal impairment; with or without food.

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Severe cutaneous reactions (erythema multiforme, SJS, TEN), some fatal; discontinue if signs appear
  • Hepatotoxicity including hepatic failure; monitor liver tests
  • Cardiovascular events (heart failure, cardiomyopathy, myocardial infarction) and hypertension
  • Haemorrhage, gastrointestinal perforation, renal failure, pulmonary embolism
  • Osteonecrosis of the jaw, mostly after intravenous bisphosphonates

Side effects

  • Most common: decreased appetite, taste disturbance, hypertension, fatigue
  • Diarrhoea, nausea, stomatitis, dyspepsia, vomiting
  • Skin discolouration, palmar-plantar erythrodysaesthesia; hypothyroidism
  • Neutropenia, thrombocytopenia, anaemia

Interactions

  • Potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, itraconazole, clarithromycin, grapefruit juice) increase sunitinib levels
  • Potent CYP3A4 inducers (e.g. rifampicin) decrease sunitinib levels

Pregnancy and breastfeeding

  • Should not be used in pregnancy or without effective contraception unless the benefit justifies the risk to the foetus.
  • Women of childbearing potential should use effective contraception.

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

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)

Source: European Medicines Agency (EMA), product information

Austria

  • Sunitinib BluefishBluefish Pharmaceuticals Ab · 1 register entry
  • Sunitinib G.L.G.L. Pharma Gmbh · 1 register entry
  • Sunitinib RivopharmHolsten Pharma Gmbh · 1 register entry
  • Sunitinib SandozSandoz Gmbh · 1 register entry
  • Sunitinib StadaStada Arzneimittel Gmbh · 1 register entry
  • Sunitinib TevaTeva B.V · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • Sunitinib AlAliud Pharma Gmbh · 1 register entry
  • Sunitinib AqvidaAqvida Gmbh · 1 register entry
  • Sunitinib BetaBetapharm Arzneimittel Gmbh · 1 register entry
  • Sunitinib BluefishBluefish Pharmaceuticals Ab · 1 register entry
  • Sunitinib DenkDenk Pharma Gmbh & Co. Kg · 1 register entry
  • Sunitinib HeumannHeumann Pharma Gmbh & Co. Generica Kg · 1 register entry
  • Sunitinib HexalHexal Ag · 1 register entry
  • Sunitinib HolstenHolsten Pharma Gmbh · 1 register entry
  • Sunitinib KoanaaKoanaa Healthcare Spain S.L. · 1 register entry
  • Sunitinib PiramalPiramal Critical Care B.V. · 1 register entry
  • Sunitinib PurenEugia Pharma (Malta) Limited · 1 register entry
  • Sunitinib RatiopharmRatiopharm Gmbh · 1 register entry
Show all 15 brand names
  • Sunitinib StadaStadapharm Gmbh · 1 register entry
  • Sunitinib VivantaVivanta Generics S.R.O. · 1 register entry
  • Sunitinib ZentivaZentiva Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • SuniksaATABAY KİMYA SAN. VE TİC. A.Ş. · 1 register entry
  • SunoGENSENTA İLAÇ SANAYİ VE TİC. A.Ş. · 4 register entries
  • SunubisNOBEL İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
  • SutentPFİZER PFE İLAÇLARI A.Ş. · 5 register entries
  • SutesgoDEVA HOLDİNG A.Ş. · 4 register entries
  • TesaraTURGUT İLAÇLARI A.Ş. · 3 register entries
  • XsunibTRPHARM İLAÇ SAN. TİC. A.Ş. · 7 register entries

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

Brand names in 28 more European countries
Belgium
Sunitinib Sandoz, Sunitinib Teva
Bulgaria
Суганет, Сунитиниб Алкалоид-Инт, Сунитиниб Зентива, Сунитиниб Мсн, Сунитиниб Тева, Сунубис
Croatia
Sunitinib Alkaloid-Int, Sunitinib Be Pharma, Sunitinib Msn, Sunitinib Pliva, Sunitinib Sandoz, Sunitinib Stada
Cyprus
Sunitinib Msn, Sunitinib Sapiens, Sutirem
Czechia
Sunitinib Pharmagen, Sunitinib Sandoz, Sunitinib Sanexcel, Sunitinib Stada, Sunitinib Teva, Sunitinib Viatris, Sunitinib Vipharm, Sunitinib Zentiva
Denmark
Sunitinib Medical Valley, Sunitinib Sandoz, Sunitinib Stada, Sunitinib Viatris
Estonia
Sunitinib Sandoz, Sunitinib Teva, Suphrex
Finland
Sunitinib Ratiopharm, Sunitinib Sandoz, Sunitinib Stada, Sunitinib Viatris
France
Sunitinib Arrow, Sunitinib Biogaran, Sunitinib Bluepharma Industria, Sunitinib Eg, Sunitinib Koanaa, Sunitinib Krka, Sunitinib Piramal, Sunitinib Sandoz, Sunitinib Teva, Sunitinib Viatris, Sunitinib Zentiva, Sunitinib Zydus
Greece
Egotux, Sunidem, Sunitinib Sandoz, Sunitinib Teva
Hungary
Klertis, Suganet, Sundit, Sunitinib Azr, Sunitinib G.L. Pharma, Sunitinib Galenika, Sunitinib Msn, Sunitinib Pharmanox, Sunitinib Sanexcel, Sunitinib Stada, Sunitinib Teva, Sunitinib Vipharm
Iceland
Sunitinib Accord, Sunitinib Demo, Sunitinib Medical Valley, Sunitinib Stada, Sunitinib Teva, Sunitinib Viatris, Sutent, Teurlata, Zesuva
Ireland
Sunitinib Bluefish, Sunitinib Rowex
Italy
Sunitinib Aurobindo, Sunitinib Dr. Reddy’s, Sunitinib Mylan, Sunitinib Sandoz, Sunitinib Teva, Sunitinib Zentiva
Latvia
Sunitinib Be Pharma, Sunitinib G.L. Pharma, Sunitinib Lv System, Sunitinib Sandoz, Sunitinib Teva
Liechtenstein
Sunitinib Accord, Sutent
Lithuania
Klertis, Sunitinib G.L. Pharma, Sunitinib Sandoz, Sunitinib Teva, Suphrex
Luxembourg
Sunitinib Teva
Malta
Sunitinib Dr. Reddy’s, Sunitinib Medichem, Sunitinib Pharmacare, Sunitinib Remedica, Sunitinib Sandoz
Netherlands
Egotux, Klertis, Suganet, Sunitinib Betapharm, Sunitinib Cf, Sunitinib Denk, Sunitinib G.L. Pharma, Sunitinib Glenmark, Sunitinib Hcs, Sunitinib Koanaa, Sunitinib Sandoz, Sunitinib Stada, Sunitinib Sun, Sunitinib Teva, Sunitinib Viatris
Norway
Sunitinib Accord, Sunitinib Medical Valley, Sunitinib Sandoz, Sunitinib Stada, Sunitinib Teva, Sunitinib Viatris, Sutent
Poland
Klertis, Sunitinib Bluefish, Sunitinib Eugia, Sunitinib G.L. Pharma, Sunitinib Glenmark, Sunitinib Medical Valley, Sunitinib Msn, Sunitinib Ranbaxy, Sunitinib Sandoz, Sunitinib Sanexcel, Sunitinib Stada, Sunitinib Vipharm, Sunitinib Zentiva
Portugal
Sunitinib Bluepharma, Sunitinib Farmoz, Sunitinib Generis, Sunitinib Msn, Sunitinib Mylan, Sunitinib Sandoz, Sunitinib Stada, Sunitinib Tecnigen, Sunitinib Teva, Sunitinib Vivanta
Romania
Klertis, Sunitinib Alkaloid-Int, Sunitinib G.L. Pharma, Sunitinib Msn, Sunitinib Sandoz, Sunitinib Sanexcel, Sunitinib Stada, Sunitinib Teva, Sunitinib Zentiva
Slovakia
Klertis, Sunitinib G.L. Pharma, Sunitinib Glenmark, Sunitinib Msn, Sunitinib Pharmagen, Sunitinib Pharmevid, Sunitinib Sandoz, Sunitinib Sanexcel, Sunitinib Stada, Sunitinib Teva, Sunitinib Vipharm, Sunitinib Zentiva
Slovenia
Sunitinib Alkaloid-Int, Sunitinib Msn, Sunitinib Teva
Spain
Sunitinib Bluepharma Indústria, Sunitinib Dr. Reddys, Sunitinib Eugia, Sunitinib Koanaa, Sunitinib Silver, Sunitinib Tecnigen, Sunitinib Teva, Sunitinib Tillomed, Sunitinib Viatris, Sunitinib Vivanta
Sweden
Sunitinib Amarox, Sunitinib Bluefish, Sunitinib Eugia, Sunitinib Glenmark, Sunitinib Medical Valley, Sunitinib Sandoz, Sunitinib Stada, Sunitinib Teva, Sunitinib Zentiva

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Sutent – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/sutent-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-27 · 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.