Ivosidenib

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

WARNING:

Keep medicine out of the reach of Children. Do not administered LuciVos in Pregnancy and Lactation patient treatment.