INDICATIONS AND USAGE

Acute Myeloid Leukemia

Midostaurin 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

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

Systemic Mastocytosis

Midostaurin 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

Patient Selection

Select patients for the treatment of AML with Midostaurin based on the presence of FLT3 mutation positivity. Information on FDA-approved tests for the detection of FLT3 mutation in AML is available at: http://www.fda.gov/CompanionDiagnostics.

Recommended Dosage in Acute Myeloid Leukemia

The recommended dose of Midostaurin 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 Midostaurin beyond induction and consolidation.

Recommended Dosage in ASM, SM-AHN, and MCL

The recommended dose of Midostaurin 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.

ADVERSE REACTIONS

The most common side effects of Midostaurin in people with AML include:

low white blood cell counts with fever (febrile neutropenia)

nausea

redness, pain, or ulcers on the inside your mouth (mucositis)

vomiting

headache

bruising

muscle or bone pain

nose bleeds

device-related infection

high blood sugar levels (hyperglycemia)

upper respiratory tract infection

abnormal electrocardiogram (QT prolongation)

The most common side effects of Midostaurin in people with ASM, SM-AHN, or MCL include:

nausea

vomiting

diarrhea

swelling in your hands, feet, or ankles

muscle or bone pain

stomach-area pain

tiredness

upper respiratory tract infection

constipation

fever

headache

trouble breathing

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/11fa3fc9-6776-49a6-b1c1-653f627c3e58/spl-doc?hl=Rydapt

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