Active Ingredient: ALECTINIB
Alectinib is an oral ALK tyrosine kinase inhibitor whose cardiac safety profile displays a literature discordance coupled with exposure-dependent bradycardia. In pooled clinical trials, alectinib showed no clinically relevant direct QTcF prolongation (maximum mean change 5.3 ms, upper 95% CI bound below 10 ms). However, it consistently induced a heart rate reduction of 11 to 13 bpm (5% incidence of sinus bradycardia). Furthermore, a 2021 WHO VigiBase pharmacovigilance study in the European Heart Journal identified a significant reporting signal for drug-induced long QT. Bradycardia exacerbates repolarization vulnerability, warranting close heart rate and ECG surveillance.
https://doi.org/10.1093/eurheartj/ehab362, https://doi.org/10.1007/s00280-017-3253-5