WARNING: QTC PROLONGATION AND TORSADES DE POINTES

MOBOCERTINIB 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 AVOID USE OF CONCOMITANT DRUGS WHICH ARE KNOWN TO PROLONG THE QTC INTERVAL AND THE USE OF STRONG OR MODERATE CYP3A INHIBITORS WITH MOBOCERTINIB, WHICH MAY FURTHER PROLONG THE QTC. WITHHOLD, REDUCE THE DOSE, OR PERMANENTLY DISCONTINUE MOBOCERTINIB BASED ON THE SEVERITY OF QTC PROLONGATION.