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'response continued approval'

Items tagged with 'response continued approval'

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Anti Cancer

COMPOSITION: Each film-coated tablet contains Tepotinib hydrochloride hydrate 250mg equivalent to Tepotinib…………………………….225mg. INDICATION: LuciTepo is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal epithelial transition (MET) exon 14 skipping alterations. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. DOSAGE AND USE: • Select patients for treatment with LuciTepo on the presence of METex14 skipping. • Recommended dosage: 450mg orally once daily with food until disease progression or unacceptable toxicity. 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 Upadacitinib… 15 mg. INDICATION: LuciUpa is a Janus kinase (JAK) inhibitor indicated for the treatment of: • Adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers. • Adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. • Adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers. DOSAGE AND USE: • Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis the recommended dosage is 15 mg once daily. • Ulcerative Colitis the recommended induction dosage is 45 mg once daily for 8 weeks. The recommended maintenance dosage is 15 mg once daily. 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 Abrocitinib…… 100 mg INDICATION: LuciAbro is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. DOSAGE AND USE: The recommended dosage of LuciAbro is 100 mg orally once daily. If an adequate response is not achieved with LuciAbro 100 mg orally daily after 12 weeks, consider increasing dosage to 200 mg orally once daily. Discontinue therapy if inadequate response is seen after dosage increase to 200 mg once daily. 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

EACH FILM-COATED LUCIELO TABLET CONTAINS: Eltrombopag Olamine equivalent to Eltrombopag free acid 25mg Eltrombopag Olamine equivalent to Eltrombopag free acid 50mg INDICATION: LuciElo is a thrombopoietin receptor agonist indicated for the treatment of 1. thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. 2. thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. 3. patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. DOSAGE AND USE: Take on an empty stomach (1 hour before or 2 hours after a meal). Chronic ITP: Initiate LuciElo at 50 mg once daily for most adult and pediatric patients 6 years and older and at 25 mg once daily for pediatric patients aged 1 to 5 years. Dose reductions are needed for patients with hepatic impairment and some patients of East Asian ancestry. Adjust to maintain platelet count greater than or equal to 50 x 109/L. Do not exceed 75 mg per day. Chronic Hepatitis C-associated Thrombocytopenia: Initiate LuciElo at 25 mg once daily for all patients. Adjust to achieve target platelet count required to initiate antiviral therapy. Do not exceed a daily dose of 100 mg. Severe Aplastic Anemia: Initiate LuciElo at 50 mg once daily for most patients. Reduce initial dose in patients with hepatic impairment or patients of East Asian ancestry. Adjust to maintain platelet count greater than 50 x 109/L. Do not exceed 150 mg per day. 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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Anti Cancer

EACH FILM-COATED LUCIELO TABLET CONTAINS: Eltrombopag Olamine equivalent to Eltrombopag free acid 25mg Eltrombopag Olamine equivalent to Eltrombopag free acid 50mg INDICATION: LuciElo is a thrombopoietin receptor agonist indicated for the treatment of 1. thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. 2. thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. 3. patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. DOSAGE AND USE: Take on an empty stomach (1 hour before or 2 hours after a meal). Chronic ITP: Initiate LuciElo at 50 mg once daily for most adult and pediatric patients 6 years and older and at 25 mg once daily for pediatric patients aged 1 to 5 years. Dose reductions are needed for patients with hepatic impairment and some patients of East Asian ancestry. Adjust to maintain platelet count greater than or equal to 50 x 109/L. Do not exceed 75 mg per day. Chronic Hepatitis C-associated Thrombocytopenia: Initiate LuciElo at 25 mg once daily for all patients. Adjust to achieve target platelet count required to initiate antiviral therapy. Do not exceed a daily dose of 100 mg. Severe Aplastic Anemia: Initiate LuciElo at 50 mg once daily for most patients. Reduce initial dose in patients with hepatic impairment or patients of East Asian ancestry. Adjust to maintain platelet count greater than 50 x 109/L. Do not exceed 150 mg per day. 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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Anti Cancer

EACH FILM-COATED LUCITRAM TABLET CONTAINS: Avatrombopag maleate 23.6mg equivalent to avatrombopag 20mg INDICATION: LuciAvat is a thrombopoietin receptor agonist indicated for the treatment of: · Thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. · Thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. DOSAGE AND USE: 1. Chronic Liver Disease: Dose LuciAvat based upon platelet count prior to procedure, orally for 5 days beginning 10 to 13 days before procedure. For platelet count less than 40 × 109/L, the dose is 60 mg (3 tablets) once daily; for platelet count 40 to less than 50 × 109/L, the dose is 40 mg (2 tablets) once daily. 2. Chronic Immune Thrombocytopenia: Initiate LuciAvat at 20 mg (1 tablet) once daily. Adjust the dose or frequency of dosing to maintain platelet count greater than or equal to 50 × 109 /L. Do not exceed 40 mg per day. Tablets should be swallowed whole & not chewed or crushed and with food. 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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Anti Cancer

Each tablet contains: Olaparib ………150mg INDICATION: LuciOlap is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: 1. Ovarian cancer · For the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. · For the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. 2. Breast cancer For the treatment of adult patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. 3. Pancreatic cancer For the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. 4. Prostate cancer For the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. DOSAGE AND USE: The recommended dosage of LuciOlap is 300 mg taken orally twice daily, with or without food. 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

COMPOSITION: Each LuciVos tablet contains: Ivosidenib…………………… 250mg INDICATION: LuciVos is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by 1. Newly Diagnosed Acute Myeloid Leukemia (AML) · In combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. 2. Relapsed or refractory AML · For the treatment of adult patients with relapsed or refractory AML. 3. Locally Advanced or Metastatic Cholangiocarcinoma · For the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma who have been previously treated. DOSAGE AND USE: 1. Newly Diagnosed AML (Combination Regimen) The recommended dosage of LuciVos is 500 mg taken orally once daily until disease progression or unacceptable toxicity. Start LuciVos administration on Cycle 1 Day 1 in combination with azacitidine 75 mg/m2 subcutaneously or intravenously once daily on Days 1-7 (or Days 1-5 and 8-9) of each 28-day cycle. For patients without disease progression or unacceptable toxicity, continue LuciVos, in combination with azacitidine, for a minimum of 6 months to allow time for clinical response. 2. Newly Diagnosed AML and Relapsed or Refractory AML (Monotherapy Regimen) The recommended dosage of LuciVos is 500 mg taken orally once daily until disease progression or unacceptable toxicity. For patients without disease progression or unacceptable toxicity, continue LuciVos for a minimum of 6 months to allow time for clinical response. 3. Cholangiocarcinoma The recommended dosage of LuciVos is 500 mg taken orally once daily until disease progression or unacceptable toxicity. 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). 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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