A REMS is a program required by the Food and Drug Administration (FDA) to manage known or potential serious risks associated with a
The purpose of the Iclusig REMS is to inform Healthcare Providers about the new safety information in the revised label including the serious risks of Iclusig. Safety updates include:
The indications have been limited to:
Arterial and venous thrombosis and occlusions have occurred in at least 27% of Iclusig clinical trial patients, including:
Iclusig can cause fatal and life-threatening vascular occlusion within 2 weeks of starting treatment. Patients with and without cardiovascular risk factors, including patients less than 50 years old, experienced these events.
|Table 1: Vascular Occlusion Incidence in Iclusig-Treated Patients in Phase 2 Trial According to Risk Categories|
|Prior history of ischemia, hypertension, diabetes, or hyperlipidemia||No history of ischemia, hypertension, diabetes, or hyperlipidemia|
|Age: 49 or younger||18% (6/33)||12% (13/112)|
|Age: 50 to 74 years||33% (50/152)||18% (20/114)|
|Age: 75 and older||56% (14/25)||46% (6/13)|
|All age groups||33% (70/210)||16% (39/239)|
Optimal dosing has not been identified.
In clinical trials, the starting dose of Iclusig was 45 mg administered orally once daily. However, 59% of the patients required dose reductions to
30 mg or 15 mg once daily during the course of therapy.
Start dosing with 45 mg once daily. Consider reducing the dose of Iclusig for chronic phase CML (CP-CML) and accelerated phase CML (AP-CML) patients who have achieved a major cytogenetic response.
Consider discontinuing Iclusig if response has not occurred by 3 months (90 days).
Do not restart Iclusig in patients with arterial or venous occlusive reactions unless the potential benefit outweighs the risk of recurrent arterial or venous occlusions and the patient has no other treatment options.
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