EXKIVITY can cause life threatening heart rate-corrected QT (QTc) prolongation, including Torsades de Pointes, which can be fatal, and requires monitoring of QTc and electrolytes at baseline and periodically during treatment. Increase monitoring frequency in patients with risk factors for QTc prolongation [see WARNINGS AND PRECAUTIONS (5.1)].
Avoid use of concomitant drugs which are known to prolong the QTc interval and use of strong or moderate CYP3A inhibitors with EXKIVITY, which may further prolong the QTc [see WARNINGS AND PRECAUTIONS (5.1), DRUG INTERACTIONS (7.1, 7.3)].
Withhold, reduce the dose, or permanently discontinue EXKIVITY based on the severity of QTc prolongation [see DOSAGE AND ADMINISTRATION (2.3)].