MedeliX
Start asking

axitinib

Inlyta · ATC code L01EK01

Also known as: Aksitinib · Brand names: Inlyta, Axitinib Al, Axitinib Hexal, Axitinib Ratiopharm, Axitinib Stada, Exigo

Key facts
Active substance
axitinib
ATC code
L01EK01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Inlyta 1 mg film-coated tablets / Inlyta 3 mg film-coated tablets / Inlyta 5 mg film-coated tablets
Marketing authorisation holder
Pfizer Europe MA EEIG
Information as of
2026-10-28

Key facts

Axitinib (Inlyta) is a tyrosine kinase inhibitor used to treat advanced renal cell carcinoma in adults after failure of prior sunitinib or cytokine therapy.

What it is used for

  • Treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.

Dosing

  • Starting dose 5 mg twice daily, continued as long as there is clinical benefit or until unacceptable toxicity.
  • Patients tolerating 5 mg twice daily without adverse reactions > Grade 2 for two consecutive weeks may be increased to 7 mg twice daily, then to a maximum of 10 mg twice daily, unless blood pressure is > 150/90 mmHg or they take antihypertensives.
  • Dose reduction for adverse reactions: to 3 mg twice daily and further to 2 mg twice daily.
  • Strong CYP3A4/5 inhibitors: avoid if possible; otherwise reduce to approximately half the dose (e.g. from 5 mg to 2 mg twice daily).
  • Moderate hepatic impairment (Child-Pugh B): dose decrease (e.g. starting dose 2 mg twice daily); no adjustment in mild impairment; not studied in severe impairment.
  • No adjustment for renal impairment or in the elderly. If a dose is vomited or missed, no extra dose is taken.

Contraindications

  • Hypersensitivity to axitinib or to any of the excipients.

Important warnings

  • Cardiac failure events have been reported; signs and symptoms should be monitored periodically.
  • Hypertension is very common and can start within days; blood pressure should be well controlled before starting and monitored, with dose reduction if it persists.
  • Other risks requiring monitoring: thyroid dysfunction, arterial and venous thromboembolic events, haemorrhage, gastrointestinal perforation and fistula, wound healing complications, PRES, proteinuria and liver enzyme elevation.

Side effects

  • Most common (≥ 20%): diarrhoea, hypertension, fatigue, decreased appetite, nausea, weight decreased, dysphonia, hand-foot syndrome, haemorrhage, hypothyroidism, vomiting, proteinuria, cough and constipation.
  • Serious: cardiac failure, thromboembolic events, gastrointestinal perforation, PRES.

Interactions

  • Strong CYP3A4/5 inhibitors (e.g. ketoconazole, itraconazole, clarithromycin, ritonavir) and grapefruit may increase axitinib levels; ketoconazole increased axitinib AUC 2-fold.
  • Strong CYP3A4/5 inducers may decrease axitinib levels; alternatives with no or minimal induction are recommended.

Pregnancy and breastfeeding

  • May cause foetal harm; should not be used during pregnancy unless clinically required. Effective contraception during and up to 1 week after treatment.
  • Should not be used during breast-feeding.

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 →

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)

  • Axitinib Accord · genericAccord Healthcare S.L.U. · EMEA/H/C/006206
  • InlytaPfizer Europe MA EEIG · EMEA/H/C/002406

Source: European Medicines Agency (EMA), product information

Austria

  • AxitinibStada Arzneimittel Gmbh, Ratiopharm Gmbh, Sandoz Gmbh · 5 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • Axitinib AlAliud Pharma Gmbh · 1 register entry
  • Axitinib HexalHexal Ag · 1 register entry
  • Axitinib RatiopharmRatiopharm Gmbh · 1 register entry
  • Axitinib StadaStadapharm Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • ExigoGENSENTA İLAÇ SANAYİ VE TİC. A.Ş. · 1 register entry
  • InlytaPFİZER PFE İLAÇLARI A.Ş. · 8 register entries

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

Brand names in 24 more European countries
Belgium
Axitinib Eg
Bulgaria
Axitinib Sandoz, Акситиниб Тева
Croatia
Aksitinib Alpha-Medical, Aksitinib Teva
Cyprus
Axitinib Sandoz, Axitinib Stada
Denmark
Axitinib Stada, Axitinib Teva
Estonia
Axitinib Sandoz, Axitinib Stada
Finland
Axitinib Avansor, Axitinib Sandoz, Axitinib Stada
France
Axitiinib Eg, Axitinib Biogaran, Axitinib Eg, Axitinib Sandoz, Axitinib Teva
Greece
Axitinib Faran, Axitinib Sandoz, Axitinib Stada, Axitinib Teva
Hungary
Axitinib Onkogen, Axitinib Sandoz
Iceland
Axitinib Accord, Axitinib Stada, Axitinib Wh, Inlyta
Italy
Axitinib Eg, Axitinib Sandoz, Axitinib Teva
Latvia
Axitinib Sandoz, Axitinib Stada
Liechtenstein
Axitinib Accord, Inlyta
Lithuania
Axitinib Sandoz, Axitinib Stada
Luxembourg
Axitinib Eg, Axitinib Synthon
Malta
Axitinib Synthon
Netherlands
Axitinib Sandoz, Axitinib Stada, Axitinib Synthon, Axitinib Teva
Norway
Axitinib Accord, Axitinib Sandoz, Axitinib Stada, Axitinib Teva, Inlyta
Portugal
Axitinib Teva
Romania
Axitinib Stada
Slovenia
Aksitinib Sandoz, Aksitinib Teva
Spain
Axitinib Stada, Axitinib Teva
Sweden
Axitinib Avansor, Axitinib Sandoz, Axitinib Stada, Axitinib Teva

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. Inlyta – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/inlyta-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. 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), 2026-10-29. 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 2026-10-28 · 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.