Pediatric transplantation · 2026
Dosing, Safety, and Tolerability of Extended-Release Tacrolimus in Pediatric and Young Adult Solid Organ Transplant Recipients.
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Dang Terry, Hewlett Jennifer, McAteer John, Downes Kevin J
Аннотация
BACKGROUND: Complicated immunosuppression regimens can contribute to non-adherence in pediatric solid organ transplant (SOT) recipients. Once-daily tacrolimus formulations, such as LCP-tacrolimus (LCPT), may help simplify dosing, but pediatric data on dosing, safety, and early tolerability are limited.
METHODS: We conducted a single center retrospective cohort study of SOT recipients prescribed LCPT from December 2016 to July 2024 at our institution. LCPT:IR-Tac daily dosing ratios were calculated. The frequency of laboratory-associated adverse events (AE) and of new patient-reported adverse events in the first 90 days were collected and compared across pediatric- and adult-aged SOT recipients.
RESULTS: Ninety-one SOT recipients were prescribed LCPT at a median age of 16.8 years (range 8.4-24.1) and 75 months after transplant (range 0.25-217). Among 53 patients who were therapeutic on both IR-Tac and LCPT, the median daily dosing ratio of LCPT:IR-Tac was 0.75 (range 0.33-1.5) for pediatric patients and 0.75 (IQR: 0.46-1.33) for adults. Eleven (5 patient-reported and 6 laboratory) AEs were identified, none of which resulted in cessation of LCPT therapy. There were no significant differences in the frequency of AEs between children and adults.
CONCLUSIONS: LCPT was well tolerated and typically required about a 25% dose reduction compared with IR-tacrolimus, though conversion ratios varied widely. These findings offer practical guidance for LCPT dosing in pediatric transplant care and highlight the need for individualized titration and monitoring.
METHODS: We conducted a single center retrospective cohort study of SOT recipients prescribed LCPT from December 2016 to July 2024 at our institution. LCPT:IR-Tac daily dosing ratios were calculated. The frequency of laboratory-associated adverse events (AE) and of new patient-reported adverse events in the first 90 days were collected and compared across pediatric- and adult-aged SOT recipients.
RESULTS: Ninety-one SOT recipients were prescribed LCPT at a median age of 16.8 years (range 8.4-24.1) and 75 months after transplant (range 0.25-217). Among 53 patients who were therapeutic on both IR-Tac and LCPT, the median daily dosing ratio of LCPT:IR-Tac was 0.75 (range 0.33-1.5) for pediatric patients and 0.75 (IQR: 0.46-1.33) for adults. Eleven (5 patient-reported and 6 laboratory) AEs were identified, none of which resulted in cessation of LCPT therapy. There were no significant differences in the frequency of AEs between children and adults.
CONCLUSIONS: LCPT was well tolerated and typically required about a 25% dose reduction compared with IR-tacrolimus, though conversion ratios varied widely. These findings offer practical guidance for LCPT dosing in pediatric transplant care and highlight the need for individualized titration and monitoring.