The complete official prescribing information should be consulted before prescribing or administering ponatinib. The following is a structured summary of the current U.S. ICLUSIG label revised in October 2025.
Indications
Current U.S. labeling includes adult patients with:
- Newly diagnosed Ph+ ALL in combination with chemotherapy.
- Selected Ph+ ALL requiring monotherapy, including T315I-positive disease.
- CP-CML resistant or intolerant to at least two prior kinase inhibitors.
- AP-CML or BP-CML for which no other kinase inhibitors are indicated.
- T315I-positive CML.
ICLUSIG is not indicated or recommended for newly diagnosed CP-CML.
Dosage
Current U.S. starting doses range from 30 mg to 45 mg once daily depending on the indication, with specific response-based dose reductions in newly diagnosed Ph+ ALL and CP-CML.
Dosage forms
Current U.S. labeling lists 10 mg, 15 mg, 30 mg and 45 mg tablets.
Contraindications
The current U.S. label lists no contraindications. This does not mean that ponatinib is appropriate for every patient.
Major warnings
The boxed warning covers arterial occlusive events, venous thromboembolic events, heart failure and hepatotoxicity.
Additional warnings include hypertension, pancreatitis, neuropathy, ocular toxicity, hemorrhage, fluid retention, arrhythmias, myelosuppression, tumor lysis syndrome, RPLS, impaired wound healing, gastrointestinal perforation and embryo-fetal toxicity.
Drug interactions
Strong CYP3A inhibitors require consideration of dose modification, and strong CYP3A inducers should be avoided.
Complete document
This page does not replace the official prescribing information.