Arterial Occlusive Events, Venous Thromboembolic Events, Heart Failure, and Hepatotoxicity

Arterial Occlusive Events:

• Arterial occlusive events (AOEs), including fatalities, have occurred in Iclusig-treated patients. AOEs included fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures. Patients with and without cardiovascular risk factors, including patients age 50 years or younger, experienced these events.
• Monitor for evidence of AOEs. Interrupt or discontinue Iclusig based on severity. Consider benefit-risk to guide a decision to restart Iclusig (2.2, 5.1)

Heart Failure:

• Heart failure, including fatalities, occurred in 8% of Iclusig-treated patients. Monitor cardiac function. Interrupt or stop Iclusig for new or worsening heart failure (5.2).

Hepatotoxicity:

• Hepatotoxicity, liver failure and death have occurred in Iclusig-treated patients. Monitor hepatic function. Interrupt Iclusig if hepatotoxicity is suspected (2.3, 5.3).