About midostauri n
Kinase inhibitor
Used for
- Treats certain newly diagnosed acute myeloid leukemia (AML) with FLT3 mutations, alongside chemotherapy.
- Treats advanced systemic mastocytosis, including aggressive systemic mastocytosis and mast-cell leukemia.
Usual adult dose
AML: 50 mg twice daily with food on days 8–21 of each chemotherapy cycle. Advanced systemic mastocytosis: 100 mg twice daily with food.
Common side effects
- Nausea, vomiting, diarrhea, or abdominal pain
- Low blood-cell counts and increased infection risk
- Swelling, headache, or muscle and bone pain
- Lung inflammation, which can cause cough or breathing difficulty
Important warnings
- May cause serious lung inflammation; assess new respiratory symptoms promptly.
- Can cause embryo-fetal harm; pregnancy testing and effective contraception are recommended.
- Monitor blood counts, lung symptoms, and heart rhythm as clinically appropriate.
- Capsules should be swallowed whole; do not open or crush.
Pregnancy
May harm an unborn baby. Avoid during pregnancy; effective contraception is recommended during treatment and for four months afterward.
Breastfeeding
Breastfeeding is not recommended during treatment and for four months after the last dose.
Interactions
- Strong CYP3A inhibitors can raise midostaurin levels; examples include ketoconazole and clarithromycin.
- Strong CYP3A inducers can lower levels; examples include rifampin and carbamazepine.
- Midostaurin may affect medicines metabolized by CYP3A; medication review is important.
AI-generated from general medical knowledge, not from this product's official leaflet. It may be incomplete or out of date. Not medical advice — ask a pharmacist or doctor before making any decision.