Gilteritinib
Other Protein Kinase Inhibitors
Sold as Xospata
- Drug class
- Other Protein Kinase Inhibitors
- Availability
- See label
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 4
Overview
Gilteritinib is an active pharmaceutical ingredient in the Other Protein Kinase Inhibitors group (L01EX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| EU European Union | EMA | 1 | January 16, 2026 |
| CA Canada | Health Canada | 1 | March 22, 2025 |
| GB United Kingdom | MHRA | 2 | September 5, 2025 |
EUEuropean Union· EMA
1 product
Uses
1).
How to take
CACanada· Health Canada
1 product
Uses
Xospata® (gilteritinib tablets) is indicated for: the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation. A validated test is required to confirm the FLT3 mutation status of AML.
1 Pediatrics Pediatrics (< 18 years of age): No clinical efficacy and safety data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use (see WARNINGS AND PRECAUTIONS, Special Populations).
2 Geriatrics Geriatrics (≥ 65 years of age): No overall differences in efficacy or safety were observed in patients 65 years or older compared to younger patients in clinical trials (see WARNINGS AND PRECAUTIONS, Special populations).
GBUnited Kingdom· MHRA
2 products
2 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].
Drug interactions
Known interactions involving Gilteritinib. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 420. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]European Medicines Agency · EMEA/H/C/004752 · revised January 16, 2026
- [2]Health Canada (DPD) · 02495058 · revised March 22, 2025
- [3]MHRA (UK) · PLPI459850967 · revised February 17, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.