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adagrasib

Krazati · ATC code L01XX77

Key facts
Active substance
adagrasib
ATC code
L01XX77
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
KRAZATI 200 mg film-coated tablets
Marketing authorisation holder
Bristol-Myers Squibb Pharma EEIG
Information as of
2026-10-28

Key facts

Adagrasib is a KRAS G12C-targeted anticancer medicine (Krazati, film-coated tablets). It is used for advanced non-small cell lung cancer with a KRAS G12C mutation.

What it is used for

  • Monotherapy for adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and disease progression after at least one prior systemic therapy.
  • The KRAS G12C mutation must be confirmed with a validated test before starting therapy.

Dosing

  • Recommended dose: 600 mg (three 200 mg tablets) twice daily, until disease progression or unacceptable toxicity.
  • Dose reductions for adverse reactions: first level 400 mg twice daily, second level 600 mg once daily.
  • Missed dose: if less than 4 hours have passed since the scheduled time, take it as normal; if more than 4 hours, skip it. Do not take an additional dose after vomiting.
  • Severe (e.g. Grade 3) adverse reactions require interruption and resumption at a lower level; details in the full text.

Contraindications

  • Hypersensitivity to the active substance or any of the excipients.
  • Concomitant use of CYP3A substrates with a narrow therapeutic index.

Important warnings

  • Gastrointestinal adverse reactions (diarrhoea, nausea, vomiting) can occur; supportive care and dose modification according to severity.
  • Hepatotoxicity: monitor liver tests before treatment, monthly for 3 months and as clinically indicated.
  • QT prolongation can occur; see the full text for monitoring details.
  • Permanently discontinue if AST or ALT > 3 × ULN with total bilirubin > 2 × ULN without alternative cause.

Side effects

  • Most common: diarrhoea (65.2%), nausea (59.9%), fatigue (54.3%), vomiting (50.3%), decreased appetite, anaemia, increased blood creatinine, increased transaminases, peripheral oedema.
  • Most common serious adverse reactions: vomiting, nausea, acute kidney injury, diarrhoea and ALT increased.
  • Pneumonitis led to treatment discontinuation in < 1%.

Interactions

  • Strong CYP3A inducers (e.g. rifampicin) markedly reduce adagrasib exposure and should be avoided.
  • Strong CYP3A inhibitors (e.g. itraconazole) increase adagrasib exposure and should be avoided.
  • Adagrasib inhibits CYP3A4 and other enzymes and transporters (including P-gp and BCRP) and may raise levels of other medicines.

Pregnancy and breastfeeding

  • Not recommended during pregnancy; no data in pregnant women.
  • Women of childbearing potential must use effective contraception during treatment and for at least 5 days after the last dose.

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)

  • KrazatiBristol-Myers Squibb Pharma EEIG · EMEA/H/C/006013

Source: European Medicines Agency (EMA), product information

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

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

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Sources

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

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.