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crizotinib

Xalkori · ATC code L01ED01

Also known as: Krizotinib

Key facts
Active substance
crizotinib
ATC code
L01ED01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
XALKORI 200 mg hard capsules / XALKORI 250 mg hard capsules / XALKORI 20 mg granules in capsules for opening
Marketing authorisation holder
Pfizer Europe MA EEIG
Information as of
2026-10-28

Key facts

Crizotinib (Xalkori) is an oral tyrosine kinase inhibitor used for ALK- or ROS1-positive advanced non-small cell lung cancer and certain ALK-positive tumours in children.

What it is used for

  • Adults: ALK-positive advanced NSCLC (first-line and previously treated) and ROS1-positive advanced NSCLC.
  • Children and adolescents (≥1 to <18 years): relapsed or refractory ALK-positive systemic anaplastic large cell lymphoma (ALCL) and recurrent or refractory unresectable ALK-positive inflammatory myofibroblastic tumour (IMT).
  • ALK or ROS1 status must be established with a validated assay before treatment.

Dosing

  • Adults with NSCLC: 250 mg twice daily (500 mg daily) taken continuously.
  • Children with ALCL or IMT: 280 mg/m2 twice daily based on body surface area, until progression or unacceptable toxicity; capsule combinations and granules see the full text.
  • Adjust the dose in severe renal impairment not requiring dialysis; adjustments for hepatic impairment and adverse reactions see the full text.

Contraindications

  • Hypersensitivity to crizotinib or any excipient.

Important warnings

  • Hepatotoxicity (including fatal cases): monitor liver tests once a week during the first 2 months, then once a month.
  • Interstitial lung disease/pneumonitis: permanently discontinue for treatment-related ILD.
  • QTc prolongation and bradycardia: weigh benefits and risks in pre-existing conditions; monitor electrolytes and ECG.
  • Visual disorders up to visual loss; ophthalmologic examinations before and during treatment in children.
  • Monitor renal function at baseline and during therapy.

Side effects

  • Most common (≥25%, adults with NSCLC): vision disorder, nausea, diarrhoea, vomiting, oedema, constipation, elevated transaminases, fatigue, decreased appetite, dizziness and neuropathy.
  • Most serious: hepatotoxicity, ILD/pneumonitis, neutropenia and QT interval prolongation.
  • Vision disorder in 63% of adult patients (mostly visual impairment, photopsia, blurred vision, vitreous floaters).

Interactions

  • Strong CYP3A inhibitors (e.g. ketoconazole) increase crizotinib levels.
  • Avoid strong CYP3A inducers (carbamazepine, phenobarbital, phenytoin, rifampicin, St John's wort).
  • Caution with medicines that prolong the QT interval or cause bradycardia.

Pregnancy and breastfeeding

  • May cause foetal harm; avoid becoming pregnant.
  • Adequate contraception during therapy and for at least 90 days afterwards.

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)

  • XalkoriPfizer Europe MA EEIG · EMEA/H/C/002489

Source: European Medicines Agency (EMA), product information

Turkey

  • XalkoriPFİZER PFE İLAÇLARI A.Ş. · 2 register entries

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

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

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. Xalkori – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/xalkori-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.