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Updated: May 25, 2026

Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS
Published on: November 8, 2015
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.
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.
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