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Optimization of Initial Dose Regimen for Sirolimus in Pediatric Patients With Lymphangioma

Xiao Chen1, Dongdong Wang1, Guangfei Wang1

  • 1Department of Pharmacy, National Children's Medical Center, Children's Hospital of Fudan University, Shanghai, China.

Frontiers in Pharmacology
|November 25, 2021
PubMed

Insights

Sirolimus effectively treats pediatric lymphangioma. This study developed a pharmacokinetic model to recommend initial sirolimus doses based on weight, optimizing treatment for children.

Area of Science:

  • Pharmacology
  • Pediatric Medicine
  • Clinical Pharmacy

Background:

  • Lymphangioma is a condition affecting pediatric patients.
  • Sirolimus is an established oral treatment for lymphangioma.
  • Understanding sirolimus pharmacokinetics in children is crucial for effective dosing.

Purpose of the Study:

  • To establish a population pharmacokinetic (PK) model for sirolimus in pediatric patients with lymphangioma.
  • To investigate factors influencing sirolimus concentrations in this population.
  • To propose an initial dosing regimen for sirolimus in pediatric lymphangioma patients.

Main Methods:

  • A clinical study involving 15 pediatric patients (0.12-16.39 years).
  • Application of a population pharmacokinetic model.
  • Monte Carlo simulation to determine dose regimens.

Main Results:

  • Body weight inversely correlates with sirolimus clearance rate.
  • Sirolimus clearance ranges from 0.31 to 0.17 L/h/kg for weights of 5-60 kg.
  • Recommended initial doses: 0.07 mg/kg/day (5-10 kg), 0.06 mg/kg/day (10-24.5 kg), and 0.05 mg/kg/day (24.5-60 kg).

Conclusions:

  • This study presents the first population PK model for sirolimus in pediatric lymphangioma.
  • The developed model provides weight-based dosing recommendations for sirolimus.
  • Further large-scale, prospective studies are warranted to validate these findings.

Keywords:
initial dose regimenlymphangiomaoptimizationpediatricsirolimus

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