'v600k mutations'

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 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 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