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'25c warning'

Items tagged with '25c warning'

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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 Mitotane……………500 mg INDICATION: LUCIMITO is indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenal cortical carcinoma. DOSAGE AND USE: The recommended initial dose of LUCIMITO is 2 g to 6 g orally, in three or four divided doses per day. Increase doses incrementally to achieve a blood concentration of 14 to 20 mg/L, or as tolerated. LUCIMITO is a cytotoxic drug. Follow applicable special handling and disposal procedures. 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 WARNING: Keep medicine out of reach of Children. Do not administer LUCIMITO during Pregnancy and Lactation.

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Anti Cancer

COMPOSITION: Each film-coated tablet contains Adagrasib……………………………. 200 mg INDICATION: LuciAda 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: • Recommended dosage: 600 mg orally twice daily. • Swallow tablets 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 WARNING: Keep medicine out of reach of Children. Do not administer LuciAda during Pregnancy and Lactation.

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Anti Cancer

Each LuciPral capsule contains: Pralsetinib ……………………… 100mg INDICATION: LuciPral is a kinase inhibitor indicated for treatment of 1. adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC). 2. Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy 1 3, 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 DOSAGE AND USE: The recommended dosage in adults and pediatric patients 12 years and older is 400 mg orally once daily on an empty stomach (no food intake for at least 2 hours before and at least 1 hour after taking LuciPral). Capsule should be swallowed whole & not chewed or crushed. STORAGE: in a dry place and store at 20°C to 25°C. WARNING: Keep medicine out of the reach of Children. Do not administered LuciLorla in Pregnancy and Lactation patient treatment.

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Anti Cancer

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.

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