'severe hepatic impairment'

COMPOSITION: Each film-coated tablet contains tucatinib….150 mg INDICATION: LuciTuca is a kinase inhibitor indicated: • in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. • in combination with trastuzumab for the treatment of adult patients with RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-,oxaliplatin-,and irinotecan-based chemotherapy. DOSAGE AND USE: • In patients with unresectable or metastatic colorectal cancer, confirm the presence of HER2 protein overexpression and RAS wild-type in tumor specimens prior to the initiation of LuciTuca. • Recommended dosage: 300 mg taken orally twice daily with or without food. • For patients with severe hepatic impairment, the recommended dosage is 200 mg orally twice 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

COMPOSITION: Each capsule contains Selumetinib sulfate 12.1mg equivalent to Selumetinib………… 10mg INDICATION: LuciSelume is a kinase inhibitor indicated for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). DOSAGE AND USE: • The recommended dosage is 25 mg/m² taken orally twice daily on an empty stomach. Do not consume food 2 hours before each dose or 1 hour after each dose. • Reduce the recommended dosage to 20 mg/m2 orally twice daily for patients with moderate hepatic impairment (Child-Pugh B). The recommended dosage for use in patients with severe hepatic impairment (Child-Pugh C) has not been established. 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

COMPOSITION: Each capsule contains Selumetinib sulfate 12.1mg equivalent to Selumetinib………… 10mg INDICATION: LuciSelume is a kinase inhibitor indicated for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). DOSAGE AND USE: • The recommended dosage is 25 mg/m² taken orally twice daily on an empty stomach. Do not consume food 2 hours before each dose or 1 hour after each dose. • Reduce the recommended dosage to 20 mg/m2 orally twice daily for patients with moderate hepatic impairment (Child-Pugh B). The recommended dosage for use in patients with severe hepatic impairment (Child-Pugh C) has not been established. 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

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

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

COMPOSITION: Each capsule contains: Selpercatinib…..………… 40mg INDICATION: LuciSel is a kinase inhibitor indicated for the treatment of: · Adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC). · Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy. · 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 (if radioactive iodine is appropriate) DOSAGE AND USE: Select patients for treatment with LuciSel based on the presence of a RET gene fusion (NSCLC or thyroid) or specific RET gene mutation (MTC). Recommended dosage in adults and pediatric patients 12 years of age or older is based on weight: ·Less than 50 kg: 120 mg orally twice daily ·50 kg or greater: 160 mg orally twice daily Reduce LuciSel dose in patients with severe hepatic impairment. 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

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

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

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