Dosing, Safety, and Tolerability of Extended-Release Tacrolimus in Pediatric and Young Adult Solid Organ Transplant

Terry Dang1, Jennifer Hewlett2, John McAteer3,4,5

  • 1Clinical Pharmacology Postdoctoral Training Program, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.

Insights

Once-daily tacrolimus (LCP-tacrolimus) is safe and effective for pediatric solid organ transplant recipients, simplifying immunosuppression. Dosing typically requires a 25% reduction from immediate-release tacrolimus, with careful monitoring recommended.

Area of Science:

  • Pharmacology
  • Transplantation Medicine
  • Pediatric Care

Background:

  • Immunosuppression regimens in pediatric solid organ transplant (SOT) recipients can be complex, potentially leading to non-adherence.
  • Once-daily tacrolimus formulations, like LCP-tacrolimus (LCPT), offer a simpler dosing schedule.
  • Limited pediatric data exists regarding LCPT dosing, safety, and early tolerability.

Purpose of the Study:

  • To evaluate the dosing, safety, and tolerability of LCP-tacrolimus in pediatric SOT recipients.
  • To compare adverse events between pediatric and adult SOT recipients on LCPT.
  • To provide practical guidance for LCPT use in pediatric transplant care.

Main Methods:

  • A retrospective cohort study of SOT recipients prescribed LCPT from December 2016 to July 2024.
  • Calculation of LCPT:IR-Tac daily dosing ratios.
  • Collection and comparison of laboratory-associated and patient-reported adverse events within 90 days for pediatric and adult patients.

Main Results:

  • Ninety-one SOT recipients were included, with a median age of 16.8 years.
  • For patients therapeutic on both formulations, the median LCPT:IR-Tac daily dosing ratio was 0.75 for both pediatric and adult recipients.
  • Eleven adverse events (5 patient-reported, 6 laboratory) were identified, with no treatment cessations and no significant differences between age groups.

Conclusions:

  • LCP-tacrolimus (LCPT) demonstrated good tolerability in SOT recipients.
  • LCPT generally required approximately a 25% dose reduction compared to immediate-release tacrolimus (IR-Tac).
  • Individualized titration and monitoring are essential for LCPT dosing in pediatric transplant recipients.
Abstract

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