Population pharmacokinetics of tacrolimus and CYP3A5-driven variability: implications for model-informed dose individualization in pediatric renal transplant recipients.

*CYP3A5* as major covariate of tacrolimus clearance, PopPK model for dose individualization

This study develops a population pharmacokinetic (PopPK) model of tacrolimus in pediatric renal transplant recipients, evaluating the impact of clinical and genetic factors on interindividual variability. CYP3A5 is identified as the major genetic covariate of tacrolimus clearance. The resulting PopPK model supports a model-informed individualized dosing strategy to optimize tacrolimus exposure.

Synthesis written by Geno'X. For the full original abstract, please refer to the source publication.

Tacrolimus is the immunosuppressant for which PGx is most mature in transplantation — CYP3A5 is a well-established clearance covariate. This pediatric population study fills a data gap in an age group where PK variability is even greater and therapeutic windows more critical.

Clinical impact: 2/3 · Evidence strength: 2/3 · Novelty: 1/2 · Sample size: 1/1 · Publication status: 0/1 → Total: 6/10