title: Conversion of twice-daily tacrolimus to once-daily tacrolimus formulation in stable pediatric kidney transplant recipients: pharmacokinetics and efficacy.
abstract: The pharmacokinetics, efficacy and safety of once-daily tacrolimus formulation (Tac-OD) were assessed in 34 stable pediatric kidney transplant recipients. Enrolled patients received their dose of twice-daily tacrolimus formulation (Tac-BID) on study Days 0 through 7. On the morning of study Day 8, the total daily doses for patients were converted to Tac-OD on a 1:1 basis and maintained on a once-daily morning dosing regimen. Tacrolimus pharmacokinetic profiles were obtained on study Days 7, 14 and 28 (after dose adjustment). Although the mean C0 concentrations (4.10 ± 1.16-3.53 ± 1.10 ng/mL, p = 0.004), and AUC0-24 (151.8 ± 41.6-129.8 ± 39.3 ng h/mL, p < 0.001) were decreased significantly after a 1:1 based conversion, there was high interindividual variability. The dose of Tac-OD was decreased in 26.5% and increased in 44.1% of patients. The resultant tacrolimus dose and pharmacokinetic profiles on study Day 28 were comparable to those on Day 7. There were no serious adverse events. In conclusion, Tac-BID can be safely converted to Tac-OD in stable pediatric kidney transplant patients with the heightened therapeutic drug monitoring. Effects of drug conversion on the cardiovascular risk factors, neurological side effects and adherence should be further evaluated.
authors.affiliation: Department of Surgery, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: S I
authors.initials: SI
authors.lastname: Min
authors.forename: J
authors.initials: J
authors.lastname: Ha
authors.forename: H G
authors.initials: HG
authors.lastname: Kang
authors.forename: S
authors.initials: S
authors.lastname: Ahn
authors.forename: T
authors.initials: T
authors.lastname: Park
authors.forename: D D
authors.initials: DD
authors.lastname: Park
authors.forename: S M
authors.initials: SM
authors.lastname: Kim
authors.forename: H J
authors.initials: HJ
authors.lastname: Hong
authors.forename: S K
authors.initials: SK
authors.lastname: Min
authors.forename: I S
authors.initials: IS
authors.lastname: Ha
authors.forename: S J
authors.initials: SJ
authors.lastname: Kim
mesh_terms: D000293:Adolescent; D019540:Area Under Curve; D002648:Child; D002675:Child, Preschool; D004334:Drug Administration Schedule; D016903:Drug Monitoring; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000493:pharmacokinetics* / Q000627:therapeutic use; D007674:Kidney Diseases / Q000601:surgery*; D016030:Kidney Transplantation; D008297:Male; D055118:Medication Adherence; D011379:Prognosis; D011446:Prospective Studies; D016559:Tacrolimus / Q000493:pharmacokinetics* / Q000627:therapeutic use; D014018:Tissue Distribution
chemical_list: D007166:Immunosuppressive Agents; D016559:Tacrolimus
keywords: Conversion; pediatric kidney transplantation; pharmacokinetics; tacrolimus