Medication therapy of high‐dose methotrexate: An evidence‐based practice guideline of the Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society

Song, Zaiwei; Hu, Yang; Liu, Shuang; Wang, Guanru; Zhai, Suodi; Zhang, Xianglin; Li, Youping; Du, Guanhua; Shi, Yuankai; Chen, Yaolong; Dong, Mei; Guo, Ruru; Guo, Wei; Huang, Hongbing; Huang, Xiao‐Jun; Jing, Hongmei; Ke, Xiaoyan; Li, Guohui; Miao, Liyan; Niu, Xiaohui; Qiu, Feng; Shen, Jingnan; Tang, Jingyan; Wang, Tianyou; Wang, Xiaoling; Wang, Zhuo; Jian-hua, WU; Zhan, Siyan; Zhang, Bikui; Zhang, Lingli; Zhang, Yanhua; Zhang, Wei; Zhao, Limei; Zhao, Libo; Jian-cun, Zhen; Zheng, Huyong; Zhu, Zhu; Jiang, Dan; Huang, Zhencheng; Tan, Zhiyuan; Lin, Qiaonan; Zhao, Rongsheng

doi:10.1111/bcp.15134

Cited by 19 publications

(45 citation statements)

References 54 publications

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“…For ALL, measurements of MTX plasma concentrations and planned leucovorin rescue (15-50 mg/m 2 every 6 h) were usually performed at 36-54 h after the start of MTX infusion (the MTX doses ranged from 2.85 to 8 g/m 2 ). 9,13,20,[26][27][28][29][30][31] For lymphoma, the measurements of MTX plasma concentrations and planned leucovorin rescue (15-25 mg/m 2 or 30-100 mg every 6 h) were usually performed at 18-48 h after the start of MTX infusion (the MTX doses ranged from 2 to 8 g/m 2 ). [32][33][34] For osteosarcoma, the measurements of MTX plasma concentrations and planned leucovorin rescue (15 mg/m 2 or 10-12 mg every 6 h) were usually performed at 6-24 h after the start of MTX infusion (the MTX doses ranged from 10 to 12 g/m 2 ).…”

Section: Resultsmentioning

confidence: 99%

“…8 Therefore, hydration, alkalinization in combination with MTX monitoring, and leucovorin rescue are routine strategies to overcome MTX-induced toxicities. 9 In clinical practice, alkalinization is typically achieved with intravenous and/or oral sodium bicarbonate, sodium acetate, or acetazolamide, and the urine pH is suggested to be maintained at 7.0 or greater before and during HDMTX therapy.…”

Section: Introductionmentioning

confidence: 99%

“…Excessive alkalinization increases the risk of an acid-base disturbance. 1,9,10 However, by using these strategies, nephrotoxicity still occurs in 2%-10% of patients. 8 Therefore, MTX plasma level-guided leucovorin rescue is used to overcome HDMTX-induced toxicities.…”

Section: Introductionmentioning

confidence: 99%

“…14 Both glucarpidase and leucovorin are recommended for the treatment of MTX-induced toxicities. 9 Glucarpidase (carboxypeptidase G2) can hydrolyse circulating MTX into its inactive form deoxyaminopteroic acid and reduce plasma MTX levels by >95% within 15 min of administration. 15 Additionally, glucarpidase cannot hydrolyse intracellular MTX; therefore, leucovorin rescue is still required after glucarpidase interventions.…”

Section: Introductionmentioning

confidence: 99%

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Leucovorin (folinic acid) rescue for high‐dose methotrexate: A review

Jiang

Mei

Zhao

2022

Clinical Pharmacy Therapeu

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High‐dose methotrexate (HDMTX) is active against various malignancies; it possesses serious toxicities and is associated with patient characteristics, dosage regimens, comedications, and physiological status. There are many strategies to overcome HDMTX‐induced toxicities, such as hydration, alkalization, leucovorin rescue, and haemodialysis. Leucovorin rescue is a cornerstone for toxicity prevention in HDMTX treatment. However, the leucovorin dose adjustment and the existence of leucovorin overrescue are still controversial. At present, various methods for calculating leucovorin doses in different tumour types have been proposed, including empirical calculations based on MTX plasma concentration, the Bleyer nomogram, and other methods. Nonetheless, leucovorin rescue protocols differ greatly across tumour types and medical institutions. Further studies are needed to investigate the optimal dosage regimen for leucovorin rescue in various tumours using HDMTX.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Leucovorin (folinic acid) rescue for high‐dose methotrexate: A review

Jiang

Mei

Zhao

2022

Clinical Pharmacy Therapeu

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“…Furthermore, the strength of the recommendations was graded using the GRADE approach ( Guyatt et al, 2008a ; Guyatt et al, 2008b ). For each clinical question, the SR group developed finding summaries and GRADE evidence profiles to clearly describe the benefits and harms ( Song et al, 2021 ). The certainty of the body of evidence was graded as high, moderate, low, or very low.…”

Section: Methodsmentioning

confidence: 99%

Recommendations for Off-Label Drug Use in Ophthalmology in China: A Clinical Practice Guideline

Wang

Wei

et al. 2022

Front. Pharmacol.

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Off-label drugs use is widespread in ophthalmology due to the delay in drug approvals and package inserts update. It has been found to vary among different medical institutions in China, leading to safety problems since inappropriate use. Guidance is urgently needed regarding how best to use the drugs for unapproved indications and routes of administration. We aimed to develop an evidence-based guideline to guide off-label drugs used in ophthalmology in China. The practice guideline was developed by the Hospital Pharmacy Professional Committee, Chinese Pharmaceutical Association, following the WHO handbook for guideline development. The guideline was initially registered in the International Practice Guidelines Registry Platform (IPGRP-2021CN096). The clinical questions included in the guideline were identified through a three-round Delphi vote. Databases search was performed in PubMed, Embase, the Cochrane Library, ClinicalTrials.gov, Chinese National Knowledge Infrastructure, and WanFang Database from their inception to 31 March 2021. Systematic reviews and meta-analyses for each clinical question were conducted individually to synthesize available scientific evidence. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was used to assess the quality of evidence and grade the recommendations’ strengths. The multidisciplinary guideline groups were set up, including ophthalmologists, pharmacists, methodology experts, pharmacologists, pharmacoeconomists, and lawyers. The guideline identified 25 clinical questions included. A total of 32 systematic reviews, including 24 conducted by the systematic review group and eight high-relevance published within 2 years, were referred to address these questions. Finally, the guideline presented 32 recommendations addressing 25 clinical questions, involving five strong recommendations and 27 weak recommendations for the treatment of ocular fundus, corneal disease, glaucoma, and endophthalmitis. Current evidence from clinical studies supports the off-label drugs used in ophthalmology. We developed an evidence-based guideline using a rigorous multidisciplinary approach to guide these usages in route clinical practice.

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Fluorescent immunochromatographic test strip for therapeutic drug monitoring of methotrexate with high sensitivity and wide dynamic range

et al. 2023

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Medication therapy of high‐dose methotrexate: An evidence‐based practice guideline of the Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society

Abstract: The authors confirm that the PI for this paper is Rongsheng Zhao and that he had direct clinical responsibility for patients included in the study investigating the patients' willingness on individualized medication of high-dose methotrexate.

Cited by 19 publications

References 54 publications

Leucovorin (folinic acid) rescue for high‐dose methotrexate: A review

Leucovorin (folinic acid) rescue for high‐dose methotrexate: A review

Recommendations for Off-Label Drug Use in Ophthalmology in China: A Clinical Practice Guideline

Fluorescent immunochromatographic test strip for therapeutic drug monitoring of methotrexate with high sensitivity and wide dynamic range

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