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ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › ANTINEOPLASTIC AGENTS › PROTEIN KINASE INHIBITORS › Other protein kinase inhibitors
midostaurin
L01EX10
Forms & Strengths
- 25mg, 50mg capsules
- Oral formulation
Adult Dosing
- 50-100mg twice daily for AML
- 50mg twice daily for SM
- Dose adjustments for hepatic or renal impairment
Pediatric Dosing
- Safety and efficacy not established
- Use with caution in patients with hepatic or renal impairment
Indications
- Acute myeloid leukemia (AML) with FLT3 mutation
- Aggressive systemic mastocytosis (SM) without mast cell leukemia
- SM with associated hematological neoplasm (AHN)
- SM with mast cell leukemia
Mechanism of Action
- Multitargeted protein kinase inhibitor
- Inhibits FLT3, KIT, PDGFR, and VEGFR
- Induces apoptosis in leukemic cells
Contraindications
- Hypersensitivity to midostaurin or excipients
- Severe hepatic impairment (Child-Pugh C)
Adverse Reactions
- Nausea, vomiting, diarrhea, abdominal pain
- Myelosuppression, anemia, thrombocytopenia, neutropenia
- Fatigue, pyrexia, headache, musculoskeletal pain
- Pulmonary edema, pneumonitis, interstitial lung disease
Drug Interactions
- Strong CYP3A4 inhibitors (e.g. ketoconazole, voriconazole)
- Strong CYP3A4 inducers (e.g. rifampicin, phenytoin)
- P-glycoprotein substrates (e.g. digoxin)
- Breast cancer resistance protein (BCRP) substrates
Curated Content: Needs Vetting Before Put to Clinical Use