Extended-release tacrolimus dosing and outcomes in pediatric and young adult transplant recipients - A single-center experience.

Abstract

Published data on LCP-tacrolimus (LCPT) in the pediatric population are limited. This single-center, retrospective, observational study describes LCPT doses needed to reach therapeutic ranges in pediatric and young adult kidney and liver transplant recipients in both de novo usage and conversion from immediate-release tacrolimus (IR-Tac). Adverse outcomes up to 12 months after LCPT initiation were also evaluated. Forty-one transplant recipients (30 kidney, 11 liver) were included. The median initial doses of LCPT were 0.034 mg/kg (IQR 0.019) de novo and 0.09 mg/kg (IQR = 0.076) converted. The median doses at first therapeutic level were 0.086 mg/kg (IQR 0.028) de novo and 0.1 mg/kg (IQR 0.066) converted. The median LCPT:IR-Tac conversion ratio initially was 0.7 and 0.75 at therapeutic levels. The rate of AKI per 100 days of exposure to IR-Tac was 0.546 and 0.439 on LCPT. The percentage of patients with rejection was not different before and after conversion (clinical rejection 8.6% [n = 3] vs 11.4% [n = 4], p = .6; biopsy-proven rejection 2.9% [n = 1] vs 11.4% [n = 4], p = .11). One patient had graft loss unrelated to rejection, and the graft was explanted. In this study, pediatric and young adult abdominal transplant recipients had therapeutic tacrolimus levels at LCPT doses below the adult-labeled dose; the conversion ratio from IR-Tac to LCPT at therapeutic level was similar. There were no identified safety concerns in de novo or converted LCPT use in pediatric and young adult patients.