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

Shuang LIU; Hongsheng CHEN; Zaiwei SONG; Qi GUO; Xianglin ZHANG; Bingyi SHI; Suodi ZHAI; Lingli ZHANG; Liyan MIAO; Liyan CUI; Xiao CHEN; Yalin DONG; Weihong GE; Xiaofei HOU; Ling JIANG; Long LIU; Lihong LIU; Maobai LIU; Tao LIN; Xiaoyang LU; Lulin MA; Changxi WANG; Jianyong WU; Wei WANG; Zhuo WANG; Ting XU; Wujun XUE; Bikui ZHANG; Guanren ZHAO; Jun ZHANG; Limei ZHAO; Qingchun ZHAO; Xiaojian ZHANG; Yi ZHANG; Yu ZHANG; Rongsheng ZHAO

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

Author: Shuang LIU ¹ ; Hongsheng CHEN ¹ ; Zaiwei SONG ¹ ; Qi GUO ¹ ; Xianglin ZHANG ² ; Bingyi SHI ³ ; Suodi ZHAI ¹ ; Lingli ZHANG ⁴ ; Liyan MIAO ⁵ ; Liyan CUI ⁶ ; Xiao CHEN ⁷ ; Yalin DONG ⁸ ; Weihong GE ⁹ ; Xiaofei HOU ¹⁰ ; Ling JIANG ¹¹ ; Long LIU ¹² ; Lihong LIU ² ; Maobai LIU ¹³ ; Tao LIN ¹⁴ ; Xiaoyang LU ¹⁵ ; Lulin MA ¹⁰ ; Changxi WANG ¹⁶ ; Jianyong WU ¹⁷ ; Wei WANG ¹⁸ ; Zhuo WANG ¹⁹ ; Ting XU ²⁰ ; Wujun XUE ²¹ ; Bikui ZHANG ²² ; Guanren ZHAO ²³ ; Jun ZHANG ²⁴ ; Limei ZHAO ²⁵ ; Qingchun ZHAO ²⁶ ; Xiaojian ZHANG ²⁷ ; Yi ZHANG ²⁸ ; Yu ZHANG ²⁹ ; Rongsheng ZHAO ³⁰
Author Information

1. Department of Pharmacy, Peking University Third Hospital, Beijing 100191, China.
2. Department of Pharmacy, China-Japan Friendship Hospital, Beijing 100029, China.
3. Kidney Transplant Quality Control Center of National Health Commission, The 8th Medical Center of Chinese PLA General Hospital,, Beijing 100000, China.
4. Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu 610041, China.
5. Department of Pharmacy, The First Affiliated Hospital of Soochow University, Suzhou 215006, China.
6. Department of Laboratory Medicine, Peking University Third Hospital, Beijing 100191, China.
7. Department of Pharmacy, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou 510080, China.
8. 8Department of Pharmacy, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, China.
9. Department of Pharmacy, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing 210008, China.
10. Department of Urology, Peking University Third Hospital, Beijing 100191, China.
11. 1Department of Pharmacy, The First Affiliated Hospital of University of Science and Technology of China, Hefei 230001, China.
12. Department of Urology, General Hospital of Northern Theater Command, Shenyang 110003, China.
13. Department of Pharmacy, Fujian Medical University Union Hospital, Fuzhou 350001, China.
14. Department of Urology, West China Hospital, Sichuan University, Chengdu 610041, China.
15. 5Department of Pharmacy, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.
16. Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou 510080, China.
17. 7Kidney Disease Center, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.
18. 8Department of Urology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing 100020, China.
19. 9Department of Pharmacy, The First Hospital Affiliated to Army Medical University, Shanghai 200433, China.
20. 0Department of Pharmacy, West China Hospital, Sichuan University, Chengdu 610041, China.
21. Department of Renal Transplantation, Nephropathy Hospital, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, China.
22. Department of Pharmacy, The Second Xiangya Hospital of Central South University, Changsha 410011, China.
23. Department of Pharmacy, The 8th Medical Center of Chinese PLA General Hospital, Beijing 100000, China.
24. Department of Clinical Pharmacy, The First Affiliated Hospital of Kunming Medical University, Kunming 650032, China.
25. Department of Pharmacy, Shengjing Hospital of China Medical University, Shenyang 110004, China.
26. 6Department of Pharmacy, General Hospital of Northern Theater Command, Shenyang 110003, China.
27. 7Department of Pharmacy, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.
28. Department of Pharmacy, Tianjin First Central Hospital, Tianjin 300192, China.
29. Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China.
30. Department of Pharmacy, Peking University Third Hospital, Beijing 100191, China. zhaorongsheng@bjmu.edu.cn.
Publication Type:Journal Article
Keywords: Grading of Recommendations Assessment, Development, and Evaluation (GRADE); Guideline; Mycophenolic acid (MPA); Solid organ transplant; Therapeutic drug monitoring (TDM)
MeSH: Mycophenolic Acid/administration & dosage*; Drug Monitoring/methods*; Humans; Organ Transplantation; Immunosuppressive Agents/administration & dosage*; Delphi Technique
From: Journal of Zhejiang University. Science. B 2025;26(9):897-914
CountryChina
Language:English
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 (C₀), 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.