Gilteritinib
Gilteritinib is an oral targeted therapy used to treat adults with acute myeloid leukemia (AML) that has a mutation in the FLT3 gene. It works by blocking the activity of FLT3 and other related kinases, which are proteins that promote cancer cell growth and survival. This medication is specifically indicated for patients with relapsed or refractory FLT3-mutated AML.
Gilteritinib is an oral targeted therapy for FLT3-mutated acute myeloid leukemia that works by inhibiting FLT3 and related tyrosine kinases to stop cancer cell growth.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- L01EX13
- RxNorm
- 2105806
- Generic
- Gilteritinib
- Class
- atc-l01
- Brands
- Xospata
- Availability
- rx
- Lactation
- unknown
- Routes
- oral
- Forms
- tablet
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Gilteritinib is used to treat adults with relapsed or refractory acute myeloid leukemia (AML) that has an FLT3 gene mutation (FLT3-ITD or FLT3-TKD). It is used as monotherapy for this specific indication.
Gilteritinib is a small molecule that inhibits multiple receptor tyrosine kinases, particularly FMS-like tyrosine kinase 3 (FLT3). By blocking FLT3 signaling, it inhibits cancer cell proliferation and promotes cell death in FLT3-mutated leukemia cells.
Gilteritinib is taken as an oral tablet once daily. Common side effects may include muscle pain, joint pain, fatigue, liver enzyme elevations, and shortness of breath. Regular blood tests and monitoring are required during treatment. Patients should be advised about potential drug interactions and the importance of adherence to the dosing schedule.
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy