Publication: Drug Design, Development and Therapy
Abstract
Ruxolitinib is used for glucocorticoid-refractory graft-versus-host disease following stem-cell transplantation, and voriconazole is commonly used in the same patients to treat fungal infections, creating potential for a metabolic drug-drug interaction through overlapping CYP pathways. This Phase I/II study in 12 patients with hematologic malignancies evaluated ruxolitinib pharmacokinetics before and during voriconazole co-administration, with parameters calculated using Phoenix WinNonlin. Voriconazole pretreatment significantly increased ruxolitinib Cmax, AUC0-t, and AUC0-inf by roughly 50-118% while reducing its apparent clearance by more than half. The findings confirm a clinically significant interaction between ruxolitinib and voriconazole, supporting a recommended ruxolitinib dose reduction when the two drugs are co-administered.
Author(s): Zhao Y, Chen P, Dou L, Li F, Li M, Xu L, Chen J, Jia M, Huang S, Wang N, Luan S, Yang J, Bai N, Liu D
Published: 2022 年 3 月 25 日
Phoenix WinNonlin: A Clinically Significant Interaction
Phoenix WinNonlin's pharmacokinetic analysis captured more than double the ruxolitinib exposure during voriconazole co-administration in this study. As part of a Phoenix platform relied on by 17 global regulatory agencies, Phoenix WinNonlin can be paired with AI PK Reports to turn an analysis into a complete PK document in minutes rather than days.
