All Names: Mstarin,Midostaurin
Indications:1. Acute Myeloid Leukemia; 2. Systemic Mastocytosis
Manufacturer:BDR Pharma,India
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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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