't315i mutation dosage'

COMPOSITION: Each LuciAsc tablet contains: 43.24mg Asciminib HCL equivalent to Asciminib ………… 40mg INDICATION: LuciAsc is a kinase inhibitor indicated for the treatment of adult patients with: · Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs). · Ph+ CML in CP Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) with the T315I mutation. DOSAGE AND USE: · Recommended Dosage in Ph+ CML in CP: 80 mg orally once daily or 40 mg twice daily. · Recommended Dosage in Ph+ CML in CP with the T315I Mutation: 200 mg orally twice daily. Avoid food for at least 2 hours before and 1 hour after taking LuciAsc. 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

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

COMPOSITION: Each tablet contains Ponatinib HCl 16.03mg equivalent to Ponatinib…………………………………………………….. 45mg. INDICATION: ndication: LuciPona is a kinase inhibitor indicated for the treatment of adult patients with: • Chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors. • Accelerated phase (AP) or blast phase (BP) CML or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) for whom no other kinase inhibitors are indicated. • T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ALL. Limitations of Use: LuciPona is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML. DOSAGE AND USE: • Recommended Dosage in CP-CML: Starting dose is 45 mg orally once daily with a reduction to 15 mg once daily upon achievement of ≤1% BCR-ABL1. • Recommended Dosage in AP-CML, BP-CML, and Ph+ALL: Starting dose is 45 mg orally once daily. • Hepatic Impairment: Reduce the starting dose to 30 mg orally once daily. LuciPona 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

COMPOSITION: Each tablet contains Ponatinib HCl 16.03mg equivalent to Ponatinib…………………………………………………….. 15mg. INDICATION: ndication: LuciPona is a kinase inhibitor indicated for the treatment of adult patients with: • Chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors. • Accelerated phase (AP) or blast phase (BP) CML or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) for whom no other kinase inhibitors are indicated. • T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ALL. Limitations of Use: LuciPona is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML. DOSAGE AND USE: • Recommended Dosage in CP-CML: Starting dose is 45 mg orally once daily with a reduction to 15 mg once daily upon achievement of ≤1% BCR-ABL1. • Recommended Dosage in AP-CML, BP-CML, and Ph+ALL: Starting dose is 45 mg orally once daily. • Hepatic Impairment: Reduce the starting dose to 30 mg orally once daily. LuciPona 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

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].

COMPOSITION: Each LuciDabra Capsule contains: 88.88mg Dabrafenib mesylate equivalent to Dabrafenib……………….. 75mg INDICATION: LuciDabra is a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation. LuciDabra is indicated, in combination with trametinib, for: · the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations. · the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations and involvement of lymph node(s), following complete resection. · the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation. · the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options. Limitations of Use: LuciDabra is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF NSCLC, or wild-type BRAF ATC. DOSAGE AND USE: The recommended dosage of LuciDabra is 150 mg orally twice daily. Take LuciDabra at least 1 hour before or at least 2 hours after a meal. 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 Tablet contains: 2.254 mg Trametinib dimethyl sulfoxide equivalent to Trametinib……………… 2mg INDICATION: LuciTram is a kinase inhibitor indicated as a single agent for the treatment of BRAF-inhibitor treatment-naïve patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations. LuciTram is indicated, in combination with dabrafenib, for: · the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations. · the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations. · the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation. · the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options. DOSAGE AND USE: The recommended dosage of LuciTram is 2 mg orally once daily. Take LuciTram at least 1 hour before or at least 2 hours after a meal. Tablet should be swallowed whole & not chewed or crushed. STORAGE: in a dry place and store at 2°C to 8°C. MANUFACTURED AND MARKETED BY: LUCIUS PHARMACEUTICALS(LAO) CO., LTD No.26, Thongmang village, Xaythany district, Vientiane Capital, Laos

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

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