Active Ingredient: MIDOSTAURINE
Midostaurin is a multitargeted kinase inhibitor (targeting FLT3 and c-KIT) whose electrophysiological safety profile exhibits a literature discordance. In a controlled phase 1 thorough QT trial in healthy volunteers (75 mg dosing), midostaurin showed no significant QTcF prolongation (mean maximum increase 0.7 ms, upper 95% CI bound 4.7 ms). However, real-world pharmacovigilance data from the WHO VigiBase database identified a significant disproportionality signal associating midostaurin with drug-induced long QT and life-threatening ventricular arrhythmias. Baseline ECG assessment and electrolyte monitoring are advised.
https://doi.org/10.1093/eurheartj/ehab362, https://doi.org/10.1007/s00280-012-1825-y