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OTC
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INN: larotrectinib
Data updated: 2026-04-25
Available in:
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About This Product
Manufacturer
Bayer AG
User Reviews
Reviews reflect personal experiences and are not medical advice. Always consult your doctor.
ATC Code
L01XE53
Source
EMA · EMEA/H/C/004919
(
ARTG
)
Vitrakvi (larotrectinib) has provisional approval in Australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that:, have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation,
are metastatic or where surgical resection is likely to result in severe morbidity, and
have either progressed following treatment or who have no satisfactory alternative therapy.
The decision to approve this indication has been made on the basis of objective response rate (ORR) and duration of response from single arm clinical studies. The sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.
⚠️ Warnings
1.Monitor liver function tests every two weeks during the first month and after that monthly. Reduce the starting dose of larotrectinib in patients with moderate liver function impairment.
2.Neurological adverse effects like gait disturbances, dizziness, tremors, delirium, memory impairment can be seen.
3.Patients are advised not to operate heavy machines if they experience these adverse effects.
4. In females who are able to get pregnant, proper contraceptives should be used during the treatment and one week after the last dose is given.
5. In males with female partners who are able to pregnant, proper contraceptives should be used during the treatment and one week after the last dose is given.
6.Patients should inform their doctors about all the medications they take including herbal medications, OTC products, and vitamin supplements.
7.Do not eat grapefruit or drink grapefruit juice.
Do not take St John Wort.