Leaflet KRAZATI 200mg film-coated tablets

Indicated for: non-small cell lung cancer

Route of administration: oral

Substance: adagrasib (antineoplastic agent)

ATC: L01XX77 (Antineoplastic and immunomodulating agents | Other antineoplastic agents)

Precautions:
Fertility warning
Fertility warning

This medicine may affect fertility.

Dose adjustment in hepatic impairment
Dose adjustment in hepatic impairment

Dose adjustment may be needed in liver disease.

Cytotoxic / special handling
Cytotoxic / special handling

Handle with special care.

Contraception required
Contraception required

Effective contraception is required during treatment.

Contraindicated during breastfeeding
Contraindicated during breastfeeding

Do not use this medicine while breastfeeding.

Contraindicated during pregnancy
Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Hepatotoxicity
Hepatotoxicity

This medicine may affect the liver.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Myelosuppression / agranulocytosis
Myelosuppression / agranulocytosis

This medicine may lower blood cell counts.

Additional monitoring
Additional monitoring

This medicine is subject to additional monitoring.

Requires periodic laboratory tests
Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Severe skin reactions
Severe skin reactions

Stop taking the medicine and seek urgent medical help if a severe rash occurs.

Adagrasib is a medication used in the treatment of certain types of cancer, particularly non-small cell lung cancer (NSCLC) with the KRAS G12C mutation. It is a specific inhibitor of the KRAS G12C mutation, which plays a key role in cancer cell growth and survival.

The medication is taken orally, usually once or twice daily, as directed by a doctor. Adagrasib has shown efficacy in reducing tumor size and slowing disease progression in patients with this specific mutation.

Common side effects include nausea, diarrhea, fatigue, and elevated levels of certain liver enzymes. In rare cases, it may cause severe liver toxicity or other serious adverse reactions.

Patients taking adagrasib should be regularly monitored for liver function and report any side effects or unusual symptoms to their doctor.

General data about KRAZATI 200mg

  • Substance: adagrasib
  • Date of latest medicines list: 01-06-2026
  • Product code: W71715001
  • Concentration: 200mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 180
  • Product type: Generic medicine
  • Price: 59750.56 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: SWORDS LABORATORIES UNLIMITED COMPANY T/A - IRLANDA
  • Holder: C.N. UNIFARM S.A. - ROMANIA
  • Number: 1174/2026/01
  • Shelf life: 2 years