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sotorasib

Lumykras · ATC code L01XX73

Key facts
Active substance
sotorasib
ATC code
L01XX73
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
LUMYKRAS 120 mg film-coated tablets / LUMYKRAS 240 mg film-coated tablets
Marketing authorisation holder
Amgen Europe B.V.
Information as of
2026-10-27

Key facts

Sotorasib is a selective KRAS G12C inhibitor (targeted cancer therapy). It is used as monotherapy for advanced non-small cell lung cancer with a KRAS G12C mutation after prior therapy.

What it is used for

  • Advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation in adults who progressed after at least one prior systemic therapy

Dosing

  • 960 mg once daily at the same time each day (eight 120 mg or four 240 mg tablets)
  • Confirm the mutation with a validated test before starting
  • Continue until disease progression or unacceptable toxicity
  • A missed dose is taken only within 6 hours; no extra dose after vomiting
  • Moderate and severe hepatic impairment: not recommended; dose modifications for toxicity in the full text

Contraindications

  • Hypersensitivity to the active substance or excipients

Important warnings

  • Hepatotoxicity including drug-induced liver injury and hepatitis; risk highest after recent immunotherapy; monitor liver tests
  • Interstitial lung disease/pneumonitis: withhold if suspected, discontinue permanently if confirmed
  • Persistent nausea, vomiting or diarrhoea may require interruption and dose reduction

Side effects

  • Most common: diarrhoea, nausea, fatigue, vomiting, arthralgia, decreased appetite
  • Most common severe reactions: diarrhoea and increased ALT and AST

Interactions

  • Acid-reducing agents (PPIs, H2 antagonists) lower sotorasib levels; if needed, take with an acidic beverage or separate from antacids
  • Strong CYP3A4 inducers (e.g. rifampicin, carbamazepine, St. John's wort): not recommended
  • Sotorasib is a moderate CYP3A4 inducer and may reduce the efficacy of CYP3A4 substrates

Pregnancy and breastfeeding

  • Highly effective contraception during treatment and for at least 7 days after the last dose; add a barrier method to hormonal contraceptives
  • Should not be used during breast-feeding

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 →

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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)

  • LumykrasAmgen Europe B.V. · EMEA/H/C/005522

Source: European Medicines Agency (EMA), product information

Turkey

  • LumakrasAMGEN İLAÇ TİC. LTD. ŞTİ. · 1 register entry

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

Brand names in 2 more European countries
Iceland
Lumykras
Norway
Lumykras

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.

Other substances in the same group

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Sources

  1. European Medicines Agency. Lumykras – 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/lumykras-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 2026-10-27 · 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.