Larotrectinib INN

Composition: Each capsule contains 100 mg of Larotrectinib INN.

Indications: Lotenib is used to treat solid tumors in adults and children with neurotrophic receptor tyrosine kinase (NTRK) gene fusion, particularly in cases where the tumor is metastatic or surgery poses a high risk of complications, and when alternative treatments have been ineffective or the disease has progressed.

Dosage and Administration: For adults and children with a body surface area of at least 1.0 meter-squared, the recommended dose is 100 mg orally twice daily, with or without food, until disease progression or unacceptable side effects. For pediatric patients with a body surface area less than 1.0 meter-squared, the recommended dose is 100 mg/m2 orally twice daily. Capsules should be swallowed whole with water and not chewed or crushed. If a dose is missed, it should not be taken within 6 hours of the next scheduled dose. If vomiting occurs after taking a dose, the next dose should be taken at the regular time.

Use in Pregnancy and Lactation: Larotrectinib may cause harm to a developing fetus if administered to pregnant women, although there is limited data available. Breastfeeding is not recommended during treatment with Larotrectinib and for 1 week after the final dose due to potential risks to the breastfed child.

Packaging: Each box contains 30 capsules.