COMPOSITION: Each LuciEntre capsule contains: Entrectinib ……. 100mg INDICATION: LuciEntre is a kinase inhibitor indicated for the treatment of: • Adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. • Adult and pediatric patients 12 years of age and older with solid tumors that: ▪have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion as detected by an FDA-approved test without a known acquired resistance mutation, ▪are metastatic or where surgical resection is likely to result in severe morbidity, and ▪have progressed following treatment or have no satisfactory alternative therapy. DOSAGE AND USE: • Recommended Dosage for ROS1-Positive Non-Small Cell Lung Cancer: 600 mg orally once daily. • Recommended Dosage for NTRK Gene Fusion-Positive Solid Tumors: ▪Adults: 600mg orally once daily. ▪Pediatric Patients 12 Years and Older: Recommended dosage is based on body surface area (BSA) as shown below □ BSA greater than 1.50 m2: 600 mg once daily. □ BSA 1.11 to 1.50 m2: 500 mg once daily. □ BSA 0.91 to 1.10 m2: 400 mg once daily. Capsules should be swallowed whole & not chewed or crushed. STORAGE: in a dry place and store at 20°C to 25°C. MANUFACTURED AND MARKETED BY: LUCIUS PHARMACEUTICALS(LAO) CO., LTD No.26, Thongmang village, Xaythany district, Vientiane Capital, Laos
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