Driving impairment
This medicine may affect your ability to drive or use machines.
Medicine information AUGTYRO 40mg capsules
- Product code:
- W72085001
- Quantity:
- 60
- Indicated for:
- advanced ROS1-positive non-small cell lung cancer in adults; advanced NTRK fusion-positive solid tumours in eligible pat
- Route of administration:
- oral
- Substance:
- repotrectinib (ROS1/TRK tyrosine kinase inhibitor)
- ATC
- L01EX28 — Antineoplastic and immunomodulating agents | Protein kinase inhibitors | Other protein kinase inhibitors
Repotrectinib is a targeted treatment for advanced ROS1-positive non-small cell lung cancer in adults and certain advanced NTRK fusion-positive solid tumours from age 12. For NTRK tumours, progression, lack of alternatives or major surgical risks are considered. Molecular testing must confirm the alteration. The medicine blocks tumour growth signals.
Swallow capsules whole, with or without food. Treatment usually starts once daily for 14 days, then twice daily as prescribed. Do not adjust the dose yourself or take an extra dose after missing one or vomiting. Liver function, muscle enzymes and uric acid need monitoring.
Dizziness, balance problems, taste changes, tingling, constipation and fatigue can occur. Important reactions include confusion, lung inflammation, liver or muscle injury and fractures. Do not drive if you feel dizzy, have blurred vision or problems with coordination.
Report a new cough, breathlessness, jaundice, unusual muscle pain or confusion promptly. Avoid grapefruit and check all new medicines with the oncology team. Treatment can harm an unborn baby and reduce the effectiveness of hormonal contraception. Effective contraception is required, including a non-hormonal method for women. Do not breastfeed during treatment.
Swallow capsules whole, with or without food. Treatment usually starts once daily for 14 days, then twice daily as prescribed. Do not adjust the dose yourself or take an extra dose after missing one or vomiting. Liver function, muscle enzymes and uric acid need monitoring.
Dizziness, balance problems, taste changes, tingling, constipation and fatigue can occur. Important reactions include confusion, lung inflammation, liver or muscle injury and fractures. Do not drive if you feel dizzy, have blurred vision or problems with coordination.
Report a new cough, breathlessness, jaundice, unusual muscle pain or confusion promptly. Avoid grapefruit and check all new medicines with the oncology team. Treatment can harm an unborn baby and reduce the effectiveness of hormonal contraception. Effective contraception is required, including a non-hormonal method for women. Do not breastfeed during treatment.
General data about AUGTYRO 40mg
- Substance:
- repotrectinib
- Date of latest medicines list:
- 01-10-2026
- Product code:
- W72085001
- Strength:
- 40mg
- Pharmaceutical form:
- capsules
- Quantity:
- 60
- Product type:
- Generic medicine
- Price:
- 24017.28 RON
- Prescription status:
- P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.
Official documents
Warnings:
Dizziness / vertigo
This medicine may cause dizziness or vertigo.
General warning
Read the package leaflet before use.
Contraception required
Effective contraception is required during treatment.
Contraindicated during breastfeeding
Do not use this medicine while breastfeeding.
Avoid grapefruit
Avoid grapefruit and grapefruit juice.
Hepatotoxicity
This medicine may affect the liver.
Major drug interactions
This medicine may have important interactions with other medicines.
Additional monitoring
This medicine is subject to additional monitoring.
Requires periodic laboratory tests
Periodic laboratory tests may be required during treatment.
Neuropathy / neurotoxicity
This medicine may affect the nerves or nervous system.
Do not split / crush / chew
Do not split, crush, or chew this medicine.
Pregnancy warning
Use during pregnancy only on medical advice.
Pediatric warning
Use in children only as recommended in the leaflet or by a doctor.
Teratogenic / fetal risk
This medicine may affect fetal development.
Drowsiness / sedation
This medicine may cause drowsiness or reduced alertness.