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'unacceptable toxicity tablets'

Items tagged with 'unacceptable toxicity tablets'

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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 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

EACH LUCISOT TABLET CONTAINS: Sotorasib ……………… 120mg INDICATION: LuciSot 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: The recommended dosage of LuciSot is 960 mg (eight 120 mg tablets) orally once daily until disease progression or unacceptable toxicity. Take LuciSot at the same time each day with or without food. Recommended LuciSot Dose Reduction Levels for Adverse Reactions: 1. First dose reduction: 480 mg (4 tablets) once daily 2. Second dose reduction: 240 mg (2 tablets) 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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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 LuciOsim tablet contains: Osimertinib……………………………80mg INDICATIONS: the treatment of patients with metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test and the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy. WARNINGS AND PRECAUTIONS: 1. Interstitial Lung Disease (ILD)/Pneumonitis: Permanently discontinue LuciOsim in patients diagnosed with ILD/Pneumonitis. 2. QTc interval Prolongation: Monitor electrocardiograms and electrolytes in patients who have a history or predisposition for QTc prolongation, or those who are taking medications that are known to prolong the QTc interval. Withhold then restart at a reduced does or permanently discontinue LuciOsim. 3. Cardiomyopathy: Conduct cardiac monitoring, including left ventricular ejection fraction(LVEF) assessment in patients with cardiac risk factors. 4. Keratitis: Promptly refer patients with signs and symptoms of keratitis to an ophthalmologist for evaluation. 5. Erythema Multiforme and Stevens-Johnson Syndrome: Withhold LuciOsim if erythema multiforme major (EMM) or Stevens-Johnson Syndrome (SJS) is suspected and permanently discontinue if confirmed. 6. Embryo-Fetal Toxicity: LuciOsim can cause fetal harm. Advise females of potential risk to the fetus and to use effective contraception during treatment with LuciOsim and for 6 weeks after final dose. Advise males to use effective contraception for 4 months, after the last does of LuciOsim. ADVERSE REACTIONS: Most common adverse reaction(≥ 20%) are diarrhea, rash, dry skin, nail toxicity, stomatitis, fatigue and decreased appetite DOSAGE: Recommended dosage: 80mg orally once daily, with or without food. PRESENTATION: Tablets: 80mg, Bottle of 30 Tablets, STORAGE: Store at 20°C to 25°C (77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

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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 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 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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