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'unacceptable toxicity storage'

Items tagged with 'unacceptable toxicity storage'

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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 LuciTivo capsule contains Tivozanib hydrochloride 1mg equivalent to Tivozanib…………………… 1.34mg. INDICATION: LuciTivo is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. DOSAGE AND USE: • Recommended Dose: 1.34 mg once daily with or without food for 21 days on treatment followed by 7 days off treatment (28-day cycle) until disease progression or unacceptable toxicity. • Dose interruptions and/or dose reduction may be needed to manage adverse reactions. • For patients with moderate hepatic impairment, reduce the dose to 0.89 mg for 21 days on treatment followed by 7 days off treatment (28-day cycle). 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 LuciTivo capsule contains Tivozanib hydrochloride 1mg equivalent to Tivozanib……………………. 0.89mg. INDICATION: LuciTivo is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. DOSAGE AND USE: • Recommended Dose: 1.34 mg once daily with or without food for 21 days on treatment followed by 7 days off treatment (28-day cycle) until disease progression or unacceptable toxicity. • Dose interruptions and/or dose reduction may be needed to manage adverse reactions. • For patients with moderate hepatic impairment, reduce the dose to 0.89 mg for 21 days on treatment followed by 7 days off treatment (28-day cycle). 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 tablet contains: Enasidenib……… 50mg INDICATION: LuciEna is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation. DOSAGE AND USE: The recommended dosage of LuciEna is 100 mg taken orally once daily with or without food until disease progression or unacceptable toxicity. 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 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 film-coated tablet contains: Venetoclax … 100mg INDICATION: LuciVenet is a BCL-2 inhibitor indicated: · For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). · In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. DOSAGE AND USE: 5-week ramp-up dosing schedule Week 1: LuciVenet 20mg once daily Week 2: LuciVenet 50mg once daily Week 3: LuciVenet 100mg once daily Week 4: LuciVenet 200mg once daily Week 5: LuciVenet 400mg once daily The recommended dosage of LuciVenet is 400 mg once daily after completion of the 5-week ramp-up dosing schedule. Continue LuciVenet until disease progression or unacceptable toxicity. 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 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 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 film-coated tablet contains: Selinexor ……………………… 20mg INDICATION: LuciSelin is a nuclear export inhibitor indicated: · In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. · In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. · For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. DOSAGE AND USE: 1 Multiple Myeloma in Combination with Bortezomib and Dexamethasone (Svd): The recommended dosage of LuciSelin is 100 mg taken orally once weekly on Day 1 of each week until disease progression or unacceptable toxicity in combination with: · Bortezomib 1.3 mg/m administered subcutaneously once weekly on Day 1 of each week for 4 weeks followed by 1 week off. · Dexamethasone 20 mg taken orally twice weekly on Days 1 and 2 of each week. 1.2 Multiple Myeloma in Combination with Dexamethasone (Sd): The recommended dosage of LuciSelin is 80 mg taken orally on Days 1 and 3 of each week until disease progression or unacceptable toxicity in combination with dexamethasone 20mg taken orally with each dose of LuciSelin on Days 1 and 3 of each week. 2 DLBCL: Recommended dosage of LuciSelin is 60 mg taken orally on Days 1 and 3 of each week. Tablet should be swallowed whole & not chewed or crushed. STORAGE: Store at or below 30°C, in a dry place. MANUFACTURED AND MARKETED BY: LUCIUS PHARMACEUTICALS(LAO) CO., LTD No.26, Thongmang village, Xaythany district, Vientiane Capital, Laos

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