Larotrectinib INN
Composition:
Lotenib-100: Each
capsule contains Larotrectinib 100mg as Larotrectinib sulfate INN
Indications: 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: Recommended Dosage in 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. Recommended Dosage in 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. 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 Larotrectinib, the
next dose should be taken at the scheduled time. Or, as directed by the registered physicians.
Use in Pregnancy and
Lactation: Larotrectinib can cause
embryo-fetal harm when administered to a pregnant
woman. There are no available data on Larotrectinib 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:
Lotenib-100: Each box contains 10 capsules in blister pack.
