A REMS is a program required by the Food and Drug Administration (FDA) to manage known or potential serious risks associated with a drug product. The purpose of the Iclusig REMS is to inform Healthcare Providers about the indications and the serious risks of Iclusig.
Safety updates include:
The indications are limited to:
Iclusig can cause fatal and life-threatening arterial occlusion within 2 weeks of starting treatment, at dose levels as low as 15 mg per day. Patients with and without cardiovascular risk factors, including patients age 50 years or younger, experienced these events (see Table 1).
|Table 1: Arterial Occlusion Incidence in Iclusig-Treated Patients in Phase 2 Trial According to Risk Categories: 4 year follow-up|
(At time of study entry)
|History of ischemia, hypertension, diabetes, or hyperlipidemia (N=218)||No History of ischemia, hypertension, diabetes, or hyperlipidemia (N=231)|
|49 or younger||31% (11/36)||19% (21/108)|
|50 to 74 years||40% (64/158)||30% (32/109)|
|75 and older||58% (14/24)||57% (8/14)|
|All age groups||41% (89/218)||26% (61/231)|
Venous thromboembolic events occurred in 6% (25/449) of Iclusig-treated patients, including deep venous thrombosis (10 patients), pulmonary embolism (7 patients), superficial thrombophlebitis (3 patients), and retinal vein thrombosis (2 patients) with vision loss.
Optimal dosing has not been identified.
In clinical trials, the starting dose of Iclusig was 45 mg administered orally once daily. However, in the phase 2 trial, 68% of the patients required dose reductions to 30 mg or 15 mg once daily during the course of therapy. At the time of analysis, there were 133 patients ongoing (110 patients with CP-CML; 20 patients with AP-CML; 3 patients with BP-CML; 0 patients with Ph+ ALL), and the median duration of Iclusig treatment was 32.2 months in patients with CP-CML, 19.4 months in patients with AP-CML, 2.9 months in patients with BP-CML and 2.7 months in patients with Ph+ ALL.
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).
Interrupt or discontinue Iclusig immediately for arterial occlusion.
Consider dose modification or discontinuation of Iclusig in patients who develop serious venous thromboembolism.
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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