Precautions of Ponatinib

1. Arterial Occlusive Events

Arterial occlusive events (AOEs), including fatalities, occurred in patients who received Iclusig in OPTIC and PACE.

Monitor for evidence of AOEs. Interrupt, then resume at the same or decreased dose or discontinue Iclusig based on recurrence/severity. Consider benefit-risk to guide a decision to restart Iclusig.

2. Venous Thromboembolic Events

Monitor for evidence of VTEs. Interrupt, then resume at the same or decreased dose or discontinue Iclusig based on recurrence/severity.

3. Heart Failure

Monitor patients for signs or symptoms consistent with heart failure and manage heart failure as clinically indicated. Interrupt, then resume at reduced dose or discontinue Iclusig for new or worsening heart failure.

4. Hepatotoxicity

Monitor liver function tests at baseline, then at least monthly or as clinically indicated. Interrupt, then resume at reduced dose or discontinue Iclusig based on recurrence/severity.

5. Hypertension

Serious or severe hypertension, including hypertensive crisis, has occurred in patients who received Iclusig.

Patients may require urgent clinical intervention for hypertension associated with confusion, headache, chest pain, or shortness of breath. Monitor blood pressure at baseline and as clinically indicated and manage hypertension as clinically indicated. Interrupt, dose reduce, or stop Iclusig if hypertension is not medically controlled. For significant worsening, labile or treatment-resistant hypertension, interrupt Iclusig and consider evaluating for renal artery stenosis.

FDA,2022.02