Midostaurin is a kinase inhibitor prescribed for adult patients facing specific health challenges. It’s designed for use in various conditions:
Newly Diagnosed Acute Myeloid Leukemia (AML):
- Specifically for cases where AML is FLT3 mutation-positive, as confirmed by an FDA-approved test.
- Administered with standard cytarabine and daunorubicin induction, followed by cytarabine consolidation.
Limitations of Use: It’s crucial to note that RYDAPT is not to be used as a standalone treatment during the induction therapy for AML.
Aggressive Systemic Mastocytosis (ASM), Systemic Mastocytosis (SM) with Associated Hematological Neoplasm (AHN), or Mast Cell Leukemia (MCL):
- Recommended for patients dealing with these specific mastocytosis-related conditions.
Dosage and Side Effects
- AML: 50 mg orally twice a day with food.
- ASM, SM-AHN, and MCL: 100 mg orally twice a day with food.
The primary adverse reactions (occurring in ≥ 20% of cases) included febrile neutropenia, nausea, mucositis, vomiting, headache, petechiae, musculoskeletal pain, epistaxis, device-related infection, hyperglycemia, prolonged QT on electrocardiogram (ECG), and upper respiratory tract infection.
ASM, SM-AHN, or MCL:
The predominant adverse reactions (≥ 20%) observed in cases of ASM, SM-AHN, or MCL encompassed nausea, vomiting, diarrhea, edema, musculoskeletal pain, abdominal pain, fatigue, upper respiratory tract infection, constipation, pyrexia, headache, and dyspnea.
Is midostaurin approved by the FDA?
On April 28, 2017, the US FDA approved midostaurin (Rydapt; Novartis Pharmaceuticals, Inc) to treat patients with newly diagnosed FLT3-mutated acute myeloid leukemia (AML).
What category is midostaurin?
Midostaurin comes in a class of kinase inhibitors. It works by hindering the action of the abnormal protein that signals cancerous cells to multiply. This helps prevent the spread of mast and cancer cells.
Is midostaurin approved in India?
Midostaurin 25 mg Capsules: On November 09, 2017, CDSCO approved Midostaurin.
How long can you take midostaurin?
If there is no sign of your cancer, you continue on Midostaurin. Maintenance treatment means you take Midostaurin twice a day for up to 12 cycles of 28 days. This can take up to 12 months.