Midostaurin 25mg

EACH FILM-COATED LUCIMIDO TABLET CONTAINS: Midostaurin ……… 50 mg

INDICATIONS

Acute Myeloid Leukemia

LuciMido is indicated in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive, as detected by an FDA approved test.

Limitations of Use

LuciMido is not indicated as a single-agent induction therapy for the treatment of patients with AML.

Systemic Mastocytosis

LuciMido is indicated for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).

DOSAGE  

Recommended dosage in Acute Myeloid Leukemia

The recommended dose of LuciMido for patients with AML is 50 mg orally twice daily with food on Days 8 to 21 of each cycle of induction with cytarabine and daunorubicin and on Days 8 to 21 of each cycle of consolidation with high-dose cytarabine. For a description of the experience with single-agent treatment with LuciMido beyond induction and consolidation.

Recommended Dosage in ASM, SM-AHN, and MCL

The recommended dose of LuciMido for patients with ASM, SM-AHN, and MCL is 100 mg orally twice daily with food. Continue treatment until disease progression or unacceptable toxicity occurs. Monitor patients for toxicity at least weekly for the first 4 weeks, every other week for the next 8 weeks, and monthly thereafter while on treatment.

Recommended Administration

• Administer prophylactic anti-emetics before treatment with LuciMido to reduce the risk of nausea and vomiting.
• Administer LuciMido orally with food, twice daily at approximately 12-hour intervals. Do not open or crush LuciMido capsules.
• If a dose of LuciMido is missed or vomited, do not make up the dose; take the next dose at the usual scheduled time.
• Consider interval assessments of QT by electrocardiogram (ECG) if LuciMido is taken concurrently with medications that can prolong the QT interval.

STORAGE

Store at 20℃ to 25℃ (68℉ to 77℉), excursions permitted between 15℃ and 30℃ (59℉ and 86℉) [see USP Controlled Room Temperature]. Protect from moisture.

MANUFACTURED AND MARKETED BY

LUCIUS PHARMACEUTICALS(LAO) CO., LTD

Address: Thongmang village, Xaythany district, Vientiane Capital, Laos