Larotrectinib

EACH LUCILAROTREC CAPSULE CONTAINS:

Larotrectinib sulfate 123mg equivalent to Larotrectinib ………… 100mg

INDICATION:

LuciLarotrec is a kinase inhibitor 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 USE:

· Recommended Dosage in Adult and Pediatric Patients with Body Surface Area of at Least 1.0 Meter-Squared: 100 mg orally twice daily.

· Recommended Dosage in Pediatric Patients with Body Surface Area of Less Than 1.0 Meter- Squared: 100 mg/m2 orally twice daily.

Tablets/Capsules should be swallowed whole & not chewed or crushed.

STORAGE:

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Keep medicine out of the reach of Children.

Manufactured and Marketed by: LUCIUS PHARMACEUTICALS(LAO) CO., LTD

No.26, Thongmang village, Xaythany district, Vientiane Capital, Laos

WARNING AND PRECAUTION:

To be sold by retail on prescription of a Registered oncologist only, and as directed by the physician.