Active Ingredient: Larotrectinib
Larotrectinib as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion,
For this indication, competent medicine agencies globally authorize below treatments:
200 - 200 mg per m² of body surface area (BSA)
From 100 To 100 mg per m² of body surface area (BSA) 2 time(s) per day every day
Dosing in paediatric patients is based on body surface area (BSA). The recommended dose in paediatric patients is 100 mg/m² larotrectinib twice daily with a maximum of 100 mg per dose until disease progression or until unacceptable toxicity occurs.
If a dose is missed, the patient should not take two doses at the same time to make up for a missed dose. Patients should take the next dose at the next scheduled time. If the patient vomits after taking a dose, the patient should not take an additional dose to make up for vomiting.
For all Grade 2 adverse reactions, continued dosing may be appropriate, though close monitoring to ensure no worsening of the toxicity is advised. Patients with Grade 2 ALT and/or AST increases, should be followed with serial laboratory evaluations every one to two weeks after the observation of Grade 2 toxicity until resolved to establish whether a dose interruption or reduction is required.
For Grade 3 or 4 adverse reactions:
The recommended dose modifications for larotrectinib for adverse reactions are provided in the following table.
Recommended dose modifications for larotrectinib for adverse reactions:
|Dose modification||Adult and paediatric patients with body surface area of at least 1.0 m²||Paediatric patients with body surface area less than 1.0 m²|
|First||75 mg twice daily||75 mg/m² twice daily|
|Second||50 mg twice daily||50 mg/m² twice daily|
|Third||100 mg once daily||25 mg/m² twice dailya|
a Paediatric patients on 25 mg/m² twice daily should remain on this dose even if body surface area becomes greater 1.0 m² during the treatment. Maximum dose should be 25 mg twice daily at the third dose modification.
Larotrectinib should be permanently discontinued in patients who are unable to tolerate larotrectinib after three dose modifications.
Larotrectinib can be taken with or without food but should not be taken with grapefruit or grapefruit juice.
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