A practice guideline for therapeutic drug monitoring of mycophenolic acid for solid organ transplants

Mycophenolic acid (MPA), the active moiety of both mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS), serves as a primary immunosuppressant for maintaining solid organ transplants. Therapeutic drug monitoring (TDM) enhances treatment outcomes through tailored approaches. This study aimed to develop an evidence-based guideline for MPA TDM, facilitating its rational application in clinical settings. The guideline plan was drawn from the Institute of Medicine and World Health Organization (WHO) guidelines. Using the Delphi method, clinical questions and outcome indicators were generated. Systematic reviews, Grading of Recommendations Assessment, Development, and Evaluation (GRADE) evidence quality evaluations, expert opinions, and patient values guided evidence-based suggestions for the guideline. External reviews further refined the recommendations. The guideline for the TDM of MPA (IPGRP-2020CN099) consists of four sections and 16 recommendations encompassing target populations, monitoring strategies, dosage regimens, and influencing factors. High-risk populations, timing of TDM, area under the curve (AUC) versus trough concentration (<i>C</i><sub>0</sub>), target concentration ranges, monitoring frequency, and analytical methods are addressed. Formulation-specific recommendations, initial dosage regimens, populations with unique considerations, pharmacokinetic-informed dosing, body weight factors, pharmacogenetics, and drug‍-‍drug interactions are covered. The evidence-based guideline offers a comprehensive recommendation for solid organ transplant recipients undergoing MPA therapy, promoting standardization of MPA TDM, and enhancing treatment efficacy and safety.

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Publication Details

Journal
Journal of Zhejiang University SCIENCE B
Published
2025-08-08
DOI
https://doi.org/10.1631/jzus.b2400069
Citations
1
Primary Topic
Renal Transplantation Outcomes and Treatments
Type
article
Field-Weighted Citation Impact
1.99

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article

A practice guideline for therapeutic drug monitoring of mycophenolic acid for solid organ transplants

Suodi Zhai, Wujun Xue, Weihong Ge, Maobai Liu et al.
1 citations
Journal of Zhejiang University SCIENCE B
Renal Transplantation Outcomes and Treatments
1.99
article

A practice guideline for therapeutic drug monitoring of mycophenolic acid for solid organ transplants

Suodi Zhai, Wujun Xue, Weihong Ge, Maobai Liu, Tao Lin, Jun Zhang, Long Liu, Yalin Dong, Liyan Miao, Ling Jiang, Lulin Ma, Bikui Zhang, Ting Xu, Zaiwei Song, Sheng Wang, Xiao Chen, Lihong Liu, Guo Qi, Lingli Zhang, Xiaoyang Lu, Xiaojian Zhang, Hongsheng Chen, Jianyong Wu, Liyan Cui, Xianglin Zhang, Changxi Wang, Bingyi Shi, Rongsheng Zhao, Zhuo Wang, Limei Zhao, Guanren Zhao, Xiaofei Hou, Yu Zhang, Qing‐Chun Zhao, Shuang Liu, Yu Zhang
article en
1 citations

Abstract

Mycophenolic acid (MPA), the active moiety of both mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS), serves as a primary immunosuppressant for maintaining solid organ transplants. Therapeutic drug monitoring (TDM) enhances treatment outcomes through tailored approaches. This study aimed to develop an evidence-based guideline for MPA TDM, facilitating its rational application in clinical settings. The guideline plan was drawn from the Institute of Medicine and World Health Organization (WHO) guidelines. Using the Delphi method, clinical questions and outcome indicators were generated. Systematic reviews, Grading of Recommendations Assessment, Development, and Evaluation (GRADE) evidence quality evaluations, expert opinions, and patient values guided evidence-based suggestions for the guideline. External reviews further refined the recommendations. The guideline for the TDM of MPA (IPGRP-2020CN099) consists of four sections and 16 recommendations encompassing target populations, monitoring strategies, dosage regimens, and influencing factors. High-risk populations, timing of TDM, area under the curve (AUC) versus trough concentration (<i>C</i><sub>0</sub>), target concentration ranges, monitoring frequency, and analytical methods are addressed. Formulation-specific recommendations, initial dosage regimens, populations with unique considerations, pharmacokinetic-informed dosing, body weight factors, pharmacogenetics, and drug‍-‍drug interactions are covered. The evidence-based guideline offers a comprehensive recommendation for solid organ transplant recipients undergoing MPA therapy, promoting standardization of MPA TDM, and enhancing treatment efficacy and safety.

Journal of Zhejiang University SCIENCE BVol. 26(9)
University of Science and Technology of China (CN), Fujian Medical University (CN), Union Hospital (HK), Central South University (CN), Army Medical University (CN), Sun Yat-sen University (CN), Peking University (CN), Sichuan University (CN), Kunming Medical University (CN), Tianjin First Center Hospital (CN), Beijing Chao-Yang Hospital, Capital Medical University (CN), China-Japan Friendship Hospital (CN), Chinese PLA General Hospital (CN), Soochow University (CN), West China Second University Hospital of Sichuan University (CN), West China Hospital of Sichuan University (CN), Nanjing Drum Tower Hospital (CN), First Affiliated Hospital of Kunming Medical University (CN), First Affiliated Hospital of Xi'an Jiaotong University (CN), The First Affiliated Hospital, Sun Yat-sen University (CN), General Hospital of Shenyang Military Region (CN), Shanghai First People's Hospital (CN), Peking University Third Hospital (CN), First Affiliated Hospital of Soochow University (CN), Second Xiangya Hospital of Central South University (CN), First Affiliated Hospital of Zhengzhou University (CN), Union Hospital (CN), First Affiliated Hospital Zhejiang University (CN), Huazhong University of Science and Technology (CN), Tianjin Medical University (CN), China Medical University (CN)
National Natural Science Foundation of China, Sun Yat-sen University, Capital Medical University, Central South University, Jilin University, Tongji University, Chongqing Medical University, Zhejiang University, Shanghai Jiao Tong University, Renji Hospital, Xiangya Hospital, Central South University, Beijing Friendship Hospital, Capital Medical University
Good health and well-being
Openalex Percentile: Top 13%
Renal Transplantation Outcomes and Treatments
1.99
DOIOpen Access PDFOpenAlex
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