Exkivity

Risk of life-threatening QTc prolongation (including Torsades de Pointes). Correct electrolyte abnormalities prior to initiation. Assess QTc and electrolytes at baseline, then periodically during treatment. Increase monitoring in those with risk factors for QTc prolongation (eg, congenital long QT syndrome, heart disease, electrolyte abnormalities). Monitor for interstitial lung disease (ILD)/pneumonitis; withhold immediately if suspected. Permanently discontinue if ILD/pneumonitis is confirmed. Risk of cardiac toxicity; monitor LVEF at baseline and during treatment; withhold, reduce dose, or permanently discontinue based on severity. Advise to start an antidiarrheal (eg, loperamide) at 1^st sign of diarrhea or increased bowel movement. Severe renal (eGFR <30mL/min/1.73m²) or hepatic (total bilirubin >3×ULN and any AST) impairment: not established. Elderly. Embryo-fetal toxicity. Advise to use effective non-hormonal contraception during and for 1 month (females of reproductive potential) or 1 week (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).