Iclusig
Iclusig ingredients
| Active ingredient | Strength |
|---|---|
| Ponatinib Hydrochloride | 10 mg/1, 30 mg/1, 15 mg/1, 45 mg/1 |
What Iclusig is used for
The FDA lists the approved uses on the official label (below). In the EU, ponatinib is approved as Iclusig for:
Iclusig is indicated as monotherapy 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. Iclusig is indicated in combination with reduced-intensity chemotherapy in adult patients with newly diagnosed Ph+ ALL (see section 5.1). Iclusig is indicated as monotherapy in paediatric patients 6 years of age or older with chronic phase chronic myeloid leukaemia (CP-CML) who are resistant to dasatinib or nil…
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Iclusig
- Generic name
- Ponatinib hydrochloride
- Made by
- Takeda Pharmaceuticals America, Inc.
- Forms
- Tablet, Film Coated
- Given
- Oral
- Drug class
- Kinase Inhibitor
- FDA approval
- New drug application (NDA) NDA203469
- On the US market since
- 2012
Official information
- Iclusig prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Ponatinib hydrochloride)
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Iclusig?
Iclusig (Ponatinib hydrochloride) is a cancer medicine made by Takeda Pharmaceuticals America, Inc., approved by the US FDA.
What are the ingredients of Iclusig?
Iclusig contains Ponatinib Hydrochloride (10 mg/1, 30 mg/1, 15 mg/1, 45 mg/1).
Is Iclusig approved in Europe?
The same active substance is approved in the EU as Iclusig.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA