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

Xiao Chen; Dongdong Wang; Guangfei Wang; Yidie Huang; Xin Yu; Jinmiao Lu; Xiaowen Zhai; Hong Xu; Zhiping Li

doi:10.3389/fphar.2021.668952

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

Front Pharmacol. 2021 Nov 8:12:668952. doi: 10.3389/fphar.2021.668952. eCollection 2021.

Authors

Xiao Chen¹, Dongdong Wang¹, Guangfei Wang¹, Yidie Huang¹, Xin Yu¹, Jinmiao Lu¹, Xiaowen Zhai², Hong Xu³, Zhiping Li¹

Affiliations

¹ Department of Pharmacy, National Children's Medical Center, Children's Hospital of Fudan University, Shanghai, China.
² Department of Hematology and Oncology, National Children's Medical Center, Children's Hospital of Fudan University, Shanghai, China.
³ Department of Nephrology, National Children's Medical Center, Children's Hospital of Fudan University, Shanghai, China.

Abstract

Sirolimus is an effective oral treatment for pediatric patients with lymphangioma. The present clinical study in 15 children (0.12-16.39 years of age) examines the effects of underlying factors on sirolimus concentrations through application of a population pharmacokinetic model. Using Monte Carlo simulation, an initial dose regimen for sirolimus in pediatric patients with lymphangioma is presented. It is found that the lower the body weight, the higher the clearance rate and sirolimus clearances are 0.31-0.17 L/h/kg in pediatric patients with lymphangioma whose weights are 5-60 kg, respectively. The doses of sirolimus, 0.07, 0.06, 0.05 mg/kg/day are recommended for weights of 5-10, 10-24.5 and 24.5-60 kg in children with lymphangioma. This study is the first to establish a population pharmacokinetic model for sirolimus and to recommend initial doses in pediatric patients with lymphangioma. Large scale, prospective studies are needed in the future.

Keywords: initial dose regimen; lymphangioma; optimization; pediatric; sirolimus.