Nebenwirkungen · Iclusig
Iclusig 15 mg film-coated tablets Iclusig 30 mg film-coated tablets Iclusig 45 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 17
HOS-128522 · Präparat HOS-096579
Previously treated CP-CML (OPTIC Study) In the OPTIC phase 2 trial (see section 5.1) overall arterial occlusive adverse reactions have occurred in 13.8% of Iclusig-treated patients (45 mg cohort) including 2 of which were fatal, and serious adverse reactions occurred in 8.5% of patients (45 mg cohort). Arterial cardiovascular, cerebrovascular, and peripheral vascular occlusive adverse reactions (treatment-emergent frequencies) occurred in 5.3%, 4.3%, and 4.3% of Iclusig-treated patients (45 mg cohort), respectively. Of the 94 patients in the 45 mg cohort, 1 patient experienced a venous thromboembolic reaction (Grade 1 retinal vein occlusion).
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