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Conversion of Twice‐Daily Tacrolimus to Once‐Daily Tacrolimus Formulation in Stable Pediatric Kidney Transplant Recipients: Pharmacokinetics and Efficacy
Author(s) -
Min S. I.,
Ha J.,
Kang H. G.,
Ahn S.,
Park T.,
Park D. D.,
Kim S. M.,
Hong H. J.,
Min S. K.,
Ha I. S.,
Kim S. J.
Publication year - 2013
Publication title -
american journal of transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.89
H-Index - 188
eISSN - 1600-6143
pISSN - 1600-6135
DOI - 10.1111/ajt.12274
Subject(s) - medicine , tacrolimus , pharmacokinetics , morning , dosing , kidney transplant , regimen , adverse effect , calcineurin , kidney transplantation , therapeutic drug monitoring , urology , kidney , pharmacology , transplantation
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 C 0 concentrations (4.10 ± 1.16–3.53 ± 1.10 ng/mL, p = 0.004), and AUC 0–24 (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.