*Purpose: Due to ongoing national drug shortages, our center transitioned to de novo use of LCP-tacrolimus (LCPT) in kidney transplant patients using a conservative dosing strategy. Herein we report the results of a study examining the doses of LCPT required to achieve therapeutic levels with secondary endpoint of time to therapeutic level, incidence of biopsy proven acute rejection (BPAR) and incidence of opportunistic infection in the early post-transplant period.

*Methods: This was a single-center retrospective cohort study of sequential adult kidney transplant alone recipients who received LCPT de novo. Patients were excluded if they were on concomitant CYP3A4/5 inhibitors. All patients received induction with rabbit antithymocyte globulin and maintenance immunosuppression of mycophenolate, prednisone, and tacrolimus with goal trough of 8-10 ng/mL for the first 3 months. LCPT was started using a weight-based strategy with lower doses (0.07-0.1 mg/kg/day) than what has been reported in clinical trials and in package labeling (0.14-0.17 mg/kg/day). Tacrolimus troughs were monitored daily during inpatient admissions and twice weekly during the first 3 months post-transplant.

*Results: Forty patients were included for analysis. Patients were 43% female, with average age of 57 years, mean BMI 30.4 kg/m2 and primarily Caucasian (55%) or African American (38%). Patients had a mean follow up period of 72 days post-transplant. LCPT was started on post-operative day 0 or 1 with mean starting dose of 0.07 mg/kg/day. Patients had a median length of stay of 3.5 days. At time of discharge, 55% of patients had a tacrolimus level <6 ng/mL, 25% had a tacrolimus level 6-11 ng/mL, 20% of patients had a tacrolimus level >11 ng/mL. Following discharge, 62% of patients experienced trough levels >15 ng/mL with a mean maximum trough of 18.6 ng/mL within 30 days of transplant. The mean time to stable, therapeutic levels was 12.7 days achieved on a mean weight-based dose of 0.07 mg/kg/day. The range of doses for therapeutic levels was 0.02-0.19 mg/kg/day. One patient experienced BPAR, 5 patients (12.5%) developed BK viremia, no CMV viremia was seen.

*Conclusions: Use of de novo LCPT with conservative weight-based dosing resulted in the majority of patients experiencing supratherapeutic tacrolimus trough levels with longer than expected time to stable, therapeutic levels. LCPT tacrolimus de novo dosing is dynamic and may require modifications from previously published weight-based dosing strategies based on this experience.

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