Identifying appropriate patients:

Considering age and comorbidities in identifying appropriate ICLUSIG^® (ponatinib) patients

Patients with and without cardiovascular risk factors, including patients age 50 years or younger, experienced arterial occlusive adverse reactions.

The median age of patients in the PACE trial was 59. In this age group (50-74 years of age), arterial occlusive adverse reactions occurred more frequently in those patients with certain cardiovascular risk factors (40%) than those patients without these cardiovascular risk factors (30%).

Consider the dose intensity-safety relationship when assessing the benefit-risk profile of ICLUSIG patients.

In the PACE trial, significant increases in grade ≥3 adverse reactions (hypertension, thrombocytopenia, pancreatitis, neutropenia, rash, ALT increase, AST increase, lipase increase, myelosuppression) corresponded with increases in the dose range of 15 to 45 mg once daily.