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COMPOSITION:
Each LuciVos tablet contains: Ivosidenib…………………… 250mg
INDICATION:
LuciVos is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by
1. Newly Diagnosed Acute Myeloid Leukemia (AML)
· In combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
2. Relapsed or refractory AML
· For the treatment of adult patients with relapsed or refractory AML.
3. Locally Advanced or Metastatic Cholangiocarcinoma
· For the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma who have been previously treated.
DOSAGE AND USE:
1. Newly Diagnosed AML (Combination Regimen)
The recommended dosage of LuciVos is 500 mg taken orally once daily until disease progression or unacceptable toxicity. Start LuciVos administration on Cycle 1 Day 1 in combination with azacitidine 75 mg/m2 subcutaneously or intravenously once daily on Days 1-7 (or Days 1-5 and 8-9) of each 28-day cycle.
For patients without disease progression or unacceptable toxicity, continue LuciVos, in combination with azacitidine, for a minimum of 6 months to allow time for clinical response.
2. Newly Diagnosed AML and Relapsed or Refractory AML (Monotherapy Regimen)
The recommended dosage of LuciVos is 500 mg taken orally once daily until disease progression or unacceptable toxicity.
For patients without disease progression or unacceptable toxicity, continue LuciVos for a minimum of 6 months to allow time for clinical response.
3. Cholangiocarcinoma The recommended dosage of LuciVos is 500 mg taken orally once daily until disease progression or unacceptable toxicity.
Tablets 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).
MANUFACTURED AND MARKETED BY:
LUCIUS PHARMACEUTICALS(LAO) CO., LTD
No.26, Thongmang village, Xaythany district, Vientiane Capital, Laos
COMPOSITION:
Each film-coated tablet contains Quizartinib dihydrochloride 20 mg equivalent to Quizartinib…………………………………17.7mg.
INDICATION:
LuciQuiza is a kinase inhibitor indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test.
DOSAGE AND USE:
• Take LuciQuiza tablets orally once daily with or without food at approximately the same time each day.
• See Full Prescribing Information for recommended LuciQuiza dosage regimen and dosage modifications.
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 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
