Active Ingredient: FILGRASTIM
(Hérité de ACCOFIL 30 MU/0) In a randomized, double-blind, placebo and active controlled Thorough QT study of 145 healthy adults, a single IV infusion of 5 µg/kg produced a peak placebo-corrected change from baseline in QTcI of only 3.5 ms (95% upper CI: 7.2 ms), well below the 10-ms regulatory threshold. Concentration-effect modeling confirmed no relationship between serum drug levels and QTc changes. No clinically significant effects on heart rate, PR, QRS, or ECG morphology were observed.
https://doi.org/10.2147/DDDT.S81799