Lotenib

Larotrectinib INN

Larotrectinib INN 100 mg

Composition: Each capsule contains Larotrectinib INN 100 mg.

Indications: Lotenib 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: Recommended Dosage in Adult and Pediatric Patients with Body Surface Area of at Least 1.0 Meter-Squared: The recommended dosage of Lotenib is 100 mg orally twice daily, with or without food, until disease progression or until unacceptable toxicity. Recommended Dosage in Pediatric Patients with Body Surface Area Less Than 1.0 Meter-Squared: The recommended dosage of Lotenib is 100 mg/m2 orally twice daily, with or without food, until disease progression or until unacceptable toxicity. Whole capsules should be swallowed with water and the capsules should not be chewed or crushed. A missed dose should not be made up within 6 hours of the next scheduled dose. If vomiting occurs after taking a dose of Lotenib, the next dose should be taken at the scheduled time. Or, as directed by the registered physicians.

Use in Pregnancy and Lactation: Lotenib can cause embryo-fetal harm when administered to a pregnant woman. There are no available data on Lotenib use in pregnant women. Pregnant women should be advised of the potential risk to a fetus. Lactation: There are no data on the presence of Larotrectinib or its metabolites in human milk and no data on its effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions in breastfed children, women should be advised not to breastfeed during treatment with Larotrectinib and for 1 week after the final dose.

Packing: Each container contains 30 capsules in a box.