Ponatinib
Bcr-Abl Tyrosine Kinase Inhibitors
Sold as Iclusig
- Drug class
- Bcr-Abl Tyrosine Kinase Inhibitors
- Availability
- See label
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 5
Overview
Ponatinib is an active pharmaceutical ingredient in the Bcr-Abl Tyrosine Kinase Inhibitors group (L01EA). 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 |
|---|---|---|---|
| GB United Kingdom | MHRA | 3 | May 22, 2026 |
| EU European Union | EMA | 1 | May 13, 2026 |
| CA Canada | Health Canada | 1 | July 11, 2025 |
GBUnited Kingdom· MHRA
3 products
Uses
Ponatinib Incyte is indicated in adult patients with • chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation • Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.
4 for situations where an alternative treatment may be considered.
How to take
EUEuropean Union· EMA
1 product
Uses
Iclusig is indicated in adult patients with • chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation 3 • Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.
1). 4 for situations where an alternative treatment may be considered.
How to take
CACanada· Health Canada
1 product
Uses
ICLUSIG (ponatinib tablets) is indicated for: • the treatment of adult patients with chronic phase (CP), accelerated phase (AP), or blast phase (BP) chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) for whom other tyrosine kinase inhibitor (TKI) therapy is not appropriate, including CML or Ph+ ALL that is T315I mutation positive or where there is prior TKI resistance or intolerance.
1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (≥ 65 years of age): Compared to patients < 65 years, older patients (with CP-CML) are more likely to experience adverse reactions.
4 Geriatrics).
Drug interactions
Known interactions involving Ponatinib. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 395. 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]MHRA (UK) · PLGB423380018 · revised May 22, 2026
- [2]European Medicines Agency · EMEA/H/C/002695 · revised May 13, 2026
- [3]Health Canada (DPD) · 02437333 · revised July 11, 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.