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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 film-coated tablet contains Belumosudil mesylate 242.5mg equivalent to Belumosudil ………………………. 200mg.
INDICATION:
LuciBelu is a kinase inhibitor indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.
DOSAGE AND USE:
Recommended Dosage: 200 mg taken orally once daily with 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 Tepotinib hydrochloride hydrate 250mg equivalent to Tepotinib…………………………….225mg.
INDICATION:
LuciTepo is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal epithelial transition (MET) exon 14 skipping alterations.
This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
DOSAGE AND USE:
• Select patients for treatment with LuciTepo on the presence of METex14 skipping.
• Recommended dosage: 450mg orally once daily with food until disease progression or unacceptable toxicity.
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 LuciRepo capsule contains: Repotrectinib ………………………….…… 40mg
INDICATION:
LuciRepo is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
DOSAGE AND USE:
• Select patients for the treatment of locally advanced or metastatic NSCLC based on the presence of ROS1 rearrangement(s) in tumor specimens.
• Recommended Dosage: 160 mg orally once daily for 14 days, then increase to 160 mg twice daily, with or without food.
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
