Development and Clinical Validation of Model-Informed Precision Dosing for Everolimus in Liver Transplant Recipients.

ABSTRACT: Everolimus presents significant dosing challenges due to between- and within-patient pharmacokinetic variabilities. This study aimed to develop and validate a model-informed precision dosing strategy for everolimus in liver transplant recipients. The dosing strategy was initially developed using retrospective data, employing nonlinear mixed-effects modeling. The model included readily measurable covariates, body surface area, albumin, and tacrolimus trough concentration. The dosing strategy was subsequently validated in a prospective trial, recommending 1 to 1.75 mg dosages every 12 h, depending on covariates. Lower dosages were recommended for patients with lower body surface area and albumin with adjustments based on tacrolimus trough concentration. The estimated pharmacokinetic paramete

SUBMITTER: Lee J 

PROVIDER: S-EPMC11729436 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature