INDICATIONS AND USAGE :

 Solid Tumors Larotrectinib is indicated for the treatment of adult and pediatric patients with solid tumors that: Have a Neurotrophic Receptor Tyrosine 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 no satisfactory alternative treatments or that have progressed following treatment.

 DOSAGE AND ADMINISTRATION Adult and Pediatric Patients with Body Surface Area of at least 1.0 Meter-Squared. The recommended dosage of Larotrectinib is 100 mg orally twice daily, with or without food, until disease progression or until unacceptable toxicity. Pediatric Patients with Body Surface Area Less Than 1.0 Meter-Squared. The recommended dosage of Larotrectinib is 100 mg/m² orally twice daily, with or without food, until disease progression or until unacceptable toxicity. Dosage Modifications for Adverse Reactions For Grade 3 or 4 adverse reactions: Withhold Larotrectinib until adverse reaction resolves or improves to baseline or Grade 1, Resume at the next dosage modification if resolution occurs within 4 weeks. Permanently discontinue Larotrectinib if an adverse reaction does not resolve within 4 weeks. The recommended dosage modifications for Larotrectinib for adverse reactions are provided in Table 1.

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