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COMPOSITION:
Each LuciTivo capsule contains Tivozanib hydrochloride 1mg equivalent to Tivozanib…………………… 1.34mg.
INDICATION:
LuciTivo is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
DOSAGE AND USE:
• Recommended Dose: 1.34 mg once daily with or without food for 21 days on treatment followed by 7 days off treatment (28-day cycle) until disease progression or unacceptable toxicity.
• Dose interruptions and/or dose reduction may be needed to manage adverse reactions.
• For patients with moderate hepatic impairment, reduce the dose to 0.89 mg for 21 days on treatment followed by 7 days off treatment (28-day cycle).
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 LUCISOT TABLET CONTAINS:
Sotorasib ……………… 120mg
INDICATION:
LuciSot 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:
The recommended dosage of LuciSot is 960 mg (eight 120 mg tablets) orally once daily until disease progression or unacceptable toxicity. Take LuciSot at the same time each day with or without food.
Recommended LuciSot Dose Reduction Levels for Adverse Reactions:
1. First dose reduction: 480 mg (4 tablets) once daily
2. Second dose reduction: 240 mg (2 tablets) once daily
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).
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 LuciTivo capsule contains Tivozanib hydrochloride 1mg equivalent to Tivozanib……………………. 0.89mg.
INDICATION:
LuciTivo is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
DOSAGE AND USE:
• Recommended Dose: 1.34 mg once daily with or without food for 21 days on treatment followed by 7 days off treatment (28-day cycle) until disease progression or unacceptable toxicity.
• Dose interruptions and/or dose reduction may be needed to manage adverse reactions.
• For patients with moderate hepatic impairment, reduce the dose to 0.89 mg for 21 days on treatment followed by 7 days off treatment (28-day cycle).
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 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 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 Upadacitinib… 15 mg.
INDICATION:
LuciUpa is a Janus kinase (JAK) inhibitor indicated for the treatment of:
• Adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers.
• Adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers.
• Adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers.
DOSAGE AND USE:
• Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis the recommended dosage is 15 mg once daily.
• Ulcerative Colitis the recommended induction dosage is 45 mg once daily for 8 weeks. The recommended maintenance dosage is 15 mg once daily.
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 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
COMPOSITION:
Each film-coated tablet contains tucatinib….150 mg
INDICATION:
LuciTuca is a kinase inhibitor indicated:
• in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.
• in combination with trastuzumab for the treatment of adult patients with RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-,oxaliplatin-,and irinotecan-based chemotherapy.
DOSAGE AND USE:
• In patients with unresectable or metastatic colorectal cancer, confirm the presence of HER2 protein overexpression and RAS wild-type in tumor specimens prior to the initiation of LuciTuca.
• Recommended dosage: 300 mg taken orally twice daily with or without food.
• For patients with severe hepatic impairment, the recommended dosage is 200 mg orally twice daily.
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 Ponatinib HCl 16.03mg equivalent to Ponatinib…………………………………………………….. 15mg.
INDICATION:
ndication:
LuciPona is a kinase inhibitor indicated for the treatment of adult patients with:
• Chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors.
• Accelerated phase (AP) or blast phase (BP) CML or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) for whom no other kinase inhibitors are indicated.
• T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ALL.
Limitations of Use: LuciPona is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML.
DOSAGE AND USE:
• Recommended Dosage in CP-CML: Starting dose is 45 mg orally once daily with a reduction to 15 mg once daily upon achievement of ≤1% BCR-ABL1.
• Recommended Dosage in AP-CML, BP-CML, and Ph+ALL: Starting dose is 45 mg orally once daily.
• Hepatic Impairment: Reduce the starting dose to 30 mg orally once daily.
LuciPona may be taken 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
