'ntrk gene fusions'

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

ACH LUCILAROTREC CAPSULE CONTAINS: Larotrectinib sulfate 123mg equivalent to Larotrectinib ………… 100mg INDICATION: LuciLarotrec is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that: · have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, · are metastatic or where surgical resection is likely to result in severe morbidity, and · have no satisfactory alternative treatments or that have progressed following treatment DOSAGE AND USE: · Recommended Dosage in Adult and Pediatric Patients with Body Surface Area of at Least 1.0 Meter-Squared: 100 mg orally twice daily. · Recommended Dosage in Pediatric Patients with Body Surface Area of Less Than 1.0 Meter-Squared: 100 mg/m2 orally twice daily. Tablets/Capsules 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 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 WARNING: Keep medicine out of reach of Children. Do not administer LuciEntre during Pregnancy and Lactation.

COMPOSITION: Each film-coated tablet contains Erdafitinib …………5 mg INDICATION: LuciErda is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) that has • susceptible FGFR3 or FGFR2 genetic alterations and • progressed during or following at least one line of prior platinum-containing chemotherapy including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. DOSAGE AND USE: • Confirm the presence of FGFR genetic alterations in tumor specimens prior to initiation of treatment with LuciErda. • Recommended initial dosage: 8 mg orally once daily with a dose increase to 9 mg daily if criteria are met. • Swallow whole 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 tablet contains Erdafitinib …………4 mg INDICATION: LuciErda is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) that has • susceptible FGFR3 or FGFR2 genetic alterations and • progressed during or following at least one line of prior platinum-containing chemotherapy including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. DOSAGE AND USE: • Confirm the presence of FGFR genetic alterations in tumor specimens prior to initiation of treatment with LuciErda. • Recommended initial dosage: 8 mg orally once daily with a dose increase to 9 mg daily if criteria are met. • Swallow whole 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 tablet contains Erdafitinib …………3 mg INDICATION: LuciErda is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) that has • susceptible FGFR3 or FGFR2 genetic alterations and • progressed during or following at least one line of prior platinum-containing chemotherapy including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. DOSAGE AND USE: • Confirm the presence of FGFR genetic alterations in tumor specimens prior to initiation of treatment with LuciErda. • Recommended initial dosage: 8 mg orally once daily with a dose increase to 9 mg daily if criteria are met. • Swallow whole 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 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 film-coated tablet contains: Sparsentan…………………………….… 400mg INDICATION: LuciSeta is an endothelin and angiotensin II receptor antagonist indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g. DOSAGE AND USE: · Prior to initiating treatment with LuciSeta, discontinue use of renin-angiotensin-aldosterone system (RAAS) inhibitors, endothelin receptor antagonists (ERAs) or aliskiren. · Initiate treatment with LuciSeta at 200 mg orally once daily. After 14 days, increase to the recommended dose of 400 mg once daily, as tolerated. When resuming treatment with LuciSeta after an interruption, consider titration of LuciSeta, starting at 200 mg once daily. After 14 days, increase to the recommended dose of 400 mg once daily. 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

Each tablet contains: Olaparib ………150mg INDICATION: LuciOlap is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: 1. Ovarian cancer · For the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. · For the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. 2. Breast cancer For the treatment of adult patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. 3. Pancreatic cancer For the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. 4. Prostate cancer For the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. DOSAGE AND USE: The recommended dosage of LuciOlap is 300 mg taken orally twice daily, with or without food. 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