Active Ingredient: DEFERASIROX
Deferasirox is an oral iron chelator used in transfusion-dependent iron overload that demonstrates no clinically significant effect on cardiac repolarization or QTc intervals. In a randomized ICH E14 thorough QT study of 182 healthy volunteers with moxifloxacin positive control, therapeutic (20 mg/kg) and supratherapeutic (40 mg/kg) doses showed non-inferiority to placebo. The upper bound of the two-sided 95% confidence interval for mean QTc difference was strictly below 8 ms over 24 hours postdose. Supratherapeutic dosing confirmed safety even at plasma exposures exceeding steady-state clinical levels.
https://www.fda.gov/media/178811/download, https://doi.org/10.5414/cpp47321