Description
Ivosidenib
Each LuciV os tablet contains: Ivosidenib … 250mg
INDICATION
LuciV os 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 LuciV os is 500 mg taken orally once daily until disease progression or unacceptable toxicity. Start LuciV os 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
LuciV os, 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 LuciV os is 500 mg taken orally once daily until disease progression or unacceptable toxicity. 3) For patients without disease progression or unacceptable toxicity, continue LuciV os for a minimum of 6 months to allow time for clinical response. 4) Cholangiocarcinoma The recommended dosage of LuciV os 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
WARNING
Keep medicine out of the reach of Children. Do not administered LuciV os in Pregnancy and Lactation patient treatment.
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