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'fdaapproved test adult'

Items tagged with 'fdaapproved test adult'

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Anti Cancer

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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Anti Cancer

COMPOSITION: Each film-coated tablet contains Brigatinib……………………………. 180 mg INDICATION: LuciBriga is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. DOSAGE AND USE: 90 mg orally once daily for the first 7 days; then increase to 180 mg orally once daily. May be taken with or without food. 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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Anti Cancer

COMPOSITION: Each film-coated tablet contains Brigatinib……………………………. 90 mg INDICATION: LuciBriga is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. DOSAGE AND USE: 90 mg orally once daily for the first 7 days; then increase to 180 mg orally once daily. May be taken with or without food. 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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Anti Cancer

COMPOSITION: Each film-coated tablet contains Adagrasib……………………………. 200 mg INDICATION: LuciAda is an inhibitor of the RAS GTPase family indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. DOSAGE AND USE: • Recommended dosage: 600 mg orally twice daily. • Swallow tablets whole with or without food. 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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Anti Cancer

COMPOSITION: Each LuciPral capsule contains: Pralsetinib ……………………… 100mg INDICATION: LuciPral is a kinase inhibitor indicated for treatment of 1. adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC). 2. Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy 1 3, Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory DOSAGE AND USE: The recommended dosage in adults and pediatric patients 12 years and older is 400 mg orally once daily on an empty stomach (no food intake for at least 2 hours before and at least 1 hour after taking LuciPral). Capsule 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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Anti Cancer

COMPOSITION: Each LuciPem tablet contains: Pemigatinib 4.5mg INDICATION: LuciPem is a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. DOSAGE AND USE: Recommended dosage is 13.5 mg orally once daily for 14 consecutive days followed by 7 days off therapy in 21-day cycles. Continue treatment until disease progression or unacceptable toxicity occurs. Severe Renal/Hepatic impairment: the recommended dosage of LuciPem is 9 mg orally once daily for 14 consecutive days followed by 7 days off therapy in 21-day cycles. Tablets 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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Anti Cancer

COMPOSITION: Each LuciMob capsule contains: 48.06mg Mobocertinib succinate equivalent to Mobocertinib 40mg INDICATION: LuciMob is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. DOSAGE AND USE: The recommended dosage of LuciMob is 160 mg orally once daily until disease progression or unacceptable toxicity. Capsule 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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Anti Cancer

COMPOSITION: Each LuciGil tablet contains: 44.2mg Gilteritinib Fumarate equivalent to Gilteritinib ……… 40mg INDICATION: LuciGil is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. DOSAGE AND USE: The recommended starting dose of LuciGil is 120 mg orally once daily with or without food. In the absence of disease progression or unacceptable toxicity, treatment for a minimum of 6 months is recommended to allow time for a clinical response. Tablet 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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Anti Cancer

EACH FILM-COATED LUCILORLA TABLET CONTAINS: Lorlatinib……………………25mg INDICATION: LuciLorla is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. DOSAGE AND USE: Recommended dosage: 100 mg orally once daily. Severe Renal Impairment: 75 mg orally once daily. Tablets 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

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