Iclusig

Risk of venous thromboembolic and arterial occlusive events (including fatal MI, stroke, stenosis of arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures) in patients with or without CV risk factors (including ≤50yrs old, or increasing age, history of ischemia, HTN, diabetes, hypercholesterolemia); monitor and interrupt or discontinue based on recurrence/severity. Monitor for heart failure; interrupt or discontinue if new or worsening condition occurs. Monitor LFTs at baseline, then at least monthly or as needed; interrupt or discontinue based on recurrence/severity. Monitor BP at baseline, as clinically needed and manage appropriately; interrupt, reduce dose or discontinue if not controlled. Evaluate for renal artery stenosis if significant worsening, labile or treatment-resistant hypertension occurs. Risk of pancreatitis; check serum lipase every 2 weeks for the first 2 months and then monthly thereafter or as clinically indicated; interrupt, resume, or discontinue based on severity. Increased toxicity in newly diagnosed chronic phase CML: not recommended. Conduct eye exams at baseline and periodically during treatment. Monitor for symptoms of neuropathy, hemorrhage, cardiac arrhythmias, or fluid retention and manage as clinically indicated; interrupt, resume at same or reduced dose, or discontinue based on recurrence/severity. Obtain CBCs every 2 weeks for the first 3 months, then monthly or as indicated; if ANC <1×10⁹/L or platelets <50×10⁹/L, interrupt until ANC ≥1.5×10⁹/L and platelets ≥75×10⁹/L, then resume at same or reduced dose. Tumor lysis syndrome: ensure adequate hydration and treat uric levels prior to therapy. Impaired wound healing: withhold for ≥1 week prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. Permanently discontinue if GI perforation occurs. Interrupt therapy if reversible posterior leukoencephalopathy syndrome occurs. Hepatic impairment. Elderly. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 3 weeks after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 6 days after the last dose).