Treatment with EXKIVITY necessitates careful monitoring for potentially life-threatening QTc prolongation and Torsades de Pointes, serious pulmonary toxicities like ILD/pneumonitis, cardiac toxicities including heart failure, severe diarrhea, and carries a risk of embryo-fetal toxicity requiring contraception.

Critical Warnings and Essential Monitoring for EXKIVITY 

Therapy EXKIVITY carries a boxed warning for QTc prolongation and Torsades de Pointes, which can be fatal. Baseline and periodic monitoring of QTc intervals and electrolytes (sodium, potassium, calcium, magnesium) are crucial, with increased frequency in at-risk patients. Concomitant use with QTc-prolonging drugs and strong or moderate CYP3A inhibitors should be avoided. Interstitial Lung Disease (ILD)/Pneumonitis, potentially fatal, has occurred (4.3% incidence, 1.2% fatal); patients require monitoring for pulmonary symptoms, and EXKIVITY should be discontinued if ILD/pneumonitis is confirmed. Cardiac toxicity, including heart failure (2.7% incidence, 0.4% fatal), necessitates baseline and ongoing cardiac function assessment (e.g., LVEF). Severe diarrhea is very common (93% incidence, 20% Grade 3); prompt antidiarrheal treatment and electrolyte monitoring are vital. EXKIVITY can cause embryo-fetal harm; effective non-hormonal contraception is required for females during treatment and for 1 month after, and for males with female partners of reproductive potential during treatment and for 1 week after.