LCP-Tacrolimus Extended-Release Tablets (Envarsus XR) Use in Pediatric Abdominal and Cardiac Solid Organ Transplant Recipients
Esther Bae1, Mary Chandran2, Melanie Everitt3, Margret Bock4.
1Pharmacy, Children's Hospital Colorado, Aurora, CO, United States; 2Pharmacy, UNC Hospitals and Clinics, Chapel Hill, NC, United States; 3Heart Institute, Children's Hospital Colorado, Aurora, CO, United States; 4Nephrology, Children's Hospital Colorado, Aurora, CO, United States
Purpose: Limited published experience describes once daily, extended-release tacrolimus (LCP-Tac) use in pediatric solid organ transplantation (SOT), particularly non-renal SOT. LCP-Tac can potentially simplify immunosuppression (IS) regimens, minimize immediate release-tacrolimus (IR-Tac)-associated adverse effects, and promote adherence. This study aims to evaluate safety of LCP-Tac use in adolescent and young adult (AYA) SOT populations.
Methods: This is a single-center, retrospective chart review of AYA SOT recipients (age < 22 years) converted from IR-Tac to LCP-Tac. Demographic and treatment data were collected up to 24 months following conversion. Graft survival and biopsy-proven acute rejection (BPAR) was assessed at five time points post-conversion (1, 3, 6, 12, and 24 months). Secondary outcome measures included infection rates, estimated glomerular filtration rate (eGFR), and effect on pill burden. Intra-patient variability of tacrolimus trough concentrations was assessed by the coefficient of variability (CV%) of serial tacrolimus trough concentrations prior to and post-conversion.
Results: Twenty-nine AYA SOT recipients (19 Heart, 6 Kidney, and 4 Liver) converted from IR-Tac to LCP-Tac. Mean age at conversion was 17.5 years, with youngest patient of 9 years. Median timing of conversion was 5.4 years post-transplant; however, 8 patients converted within the first-year. Conversion was most common for perceived or identified medication non-adherence. No graft loss occurred following conversion, and the BPAR incidence rate was similar to those reported for these populations. Infection occurred in only 1 patient (CMV viremia at 6 months post-conversion that resolved by 12 months). Renal function remained stable post-conversion over the 24-month period.
Conclusions: Conversion from IR-Tac to LCP-Tac is safe in a cohort of AYA SOT recipients. Though medication non-adherence was a primary reason for use of LCP-Tac, this study was not designed to evaluate impact of conversion on adherence. Pill burden was reduced, and CV% initially improved following conversion. Further research is needed to evaluate targeted use of LCP-Tac for IS tolerability and adherence in young SOT populations.
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