Population pharmacokinetics of rivaroxaban in Chinese deep vein thrombosis patients and the exposure simulation for dosing recommendation.

Rivaroxaban dosing guidance tailored to Chinese patients with deep vein thrombosis (DVT), incorporating renal function, had not been established via population pharmacokinetic modeling. This study used 217 plasma concentrations from 60 Chinese DVT patients to build a population pharmacokinetic model with Phoenix NLME, then used Monte Carlo simulation to derive renal-function-based dosing recommendations for acute and continued treatment phases. Estimated glomerular filtration rate was the major covariate influencing rivaroxaban clearance, with simulations suggesting dose reductions below the standard label recommendation may be needed for patients with mild or moderate renal impairment. The resulting dosage regimen table offers tailored rivaroxaban dosing guidance for Chinese DVT patients based on renal function.