Active Ingredient: LAPATINIB
Lapatinib is a dual EGFR/HER2 tyrosine kinase inhibitor that demonstrates a treatment-related increase in QTcF intervals. In a multicenter placebo-controlled study evaluating supratherapeutic dosing (three 2000 mg doses), the maximum baseline-adjusted placebo-matched QTcF increase was 8.8 ms, with an upper 90% confidence limit of 13.4 ms exceeding the regulatory 10 ms threshold. No patients had QTcF increases exceeding 60 ms. Caution and ECG monitoring are required, especially when co-administered with strong CYP3A4 inhibitors or other QT-prolonging agents.
https://doi.org/10.1007/s00280-019-03880-9, https://doi.org/10.1007/s40264-013-0047-5