---
title: "Guidelines for Off‑Label Use of Anti‑Tuberculosis Drugs: Recommendations and Monitoring"
id: "pubmed-42706201"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42706201"
content_type: "clinical_feed_article"
specialty: "Pharmacology"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42706201/"
doi: "10.3760/cma.j.cn112147-20251230-00836"
published_at: "2026-09-12T00:00:00.000Z"
evidence_level: "English Abstract"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Guidelines for Off‑Label Use of Anti‑Tuberculosis Drugs: Recommendations and Monitoring
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42706201
- **Specialty:** [Pharmacology](https://medichelpline.com/clinical-feed/pharmacology.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42706201/)
- **DOI:** [10.3760/cma.j.cn112147-20251230-00836](https://doi.org/10.3760%2Fcma.j.cn112147-20251230-00836)
- **Published At:** 2026-09-12T00:00:00.000Z
- **Evidence Rating:** English Abstract
## Executive GIST (TL;DR)
- Tuberculosis remains a major global public health problem; WHO estimated ~10.7 million incident cases and ~1.23 million deaths in 2024. China continues to face a high burden of TB and **MDR/RR-TB**. - New and repurposed agents (for example, **bedaquiline** and **linezolid**) and evidence for all‑oral shorter regimens have outpaced updates to domestic drug labeling, prompting frequent off‑label clinical use. - Off‑label use includes deviations from approved indications, dosing, duration, route, or target population and is common for both new and established agents (isoniazid, rifamycins, fluoroquinolones, carbapenems) in complex resistance, intolerance, or special populations. - The Chinese Medical Association Tuberculosis Branch produced a guideline using **GRADE** and RIGHT standards, updating an expert consensus (2023) and systematically reviewing literature through June 10, 2025. - The guideline covers 13 commonly used anti‑tuberculosis drugs and issues: off‑label indications, dosing, duration, administration routes, target populations, safety monitoring, and therapeutic drug monitoring (**TDM**). - A total of 25 recommendations were developed addressing evidence‑based, legally aware, and safety‑focused practices for off‑label use. - Core recommendations include requirements for adequate evidence and informed consent for off‑label use, individualized safety monitoring plans, and use of TDM and genotype (NAT2) to guide dosing in select cases. - Specific drug recommendations include: high‑dose or targeted **isoniazid** for low‑level resistance and some CNS cases (with pyridoxine and monitoring); rifampicin/rifapentine regimens for preventive therapy; key roles for **levofloxacin** and **moxifloxacin** in fluoroquinolone‑susceptible MDR/RR‑TB; linezolid as a core oxazolidinone with toxicity monitoring and TDM considerations; **contezolid** as an alternative when linezolid intolerance or high toxicity risk exists. - Recommendations for newer or repurposed agents: **bedaquiline** and **delamanid** are core options for MDR/RR‑TB with defined monitoring (QTcF, hepatic function, electrolytes, albumin) and permitted off‑label uses including children, pregnancy after risk/benefit assessment, extrapulmonary disease, and extended durations in certain circumstances. - Injectable aminoglycoside **amikacin** and carbapenems (meropenem or imipenem/cilastatin plus clavulanate) are reserved for selected situations, with emphasis on renal, auditory, and TDM monitoring for amikacin, and cautious use of carbapenems as Group C options when Group A/B cannot form an effective regimen. - The guideline emphasizes individualized decision‑making, specialist evaluation for local administration, and increased monitoring frequency for higher‑risk patients; conflict of interest statements report no competing interests.
## Clinical Analysis & Structured Key Points
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Zhonghua Jie He He Hu Xi Za Zhi. 2026. Show details Display options Display options Format Abstract PubMed PMID Zhonghua Jie He He Hu Xi Za Zhi Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Zhonghua+Jie+He+He+Hu+Xi+Za+Zhi%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22Zhonghua+Jie+He+He+Hu+Xi+Za+Zhi%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42706201/) . 2026 Sep 12;49(9):924-944. doi: 10.3760/cma.j.cn112147-20251230-00836. ### Author [Chinese Society for Tuberculosis, Chinese Medical Association](https://pubmed.ncbi.nlm.nih.gov/?term=Chinese+Society+for+Tuberculosis%2C+Chinese+Medical+Association%5BCorporate+Author%5D) * PMID: **42706201** * DOI: [ 10.3760/cma.j.cn112147-20251230-00836 ](https://doi.org/10.3760/cma.j.cn112147-20251230-00836) Item in Clipboard Full text links Cite Display options Display options Format Abstract PubMed PMID ## Abstract in [ English, ](https://pubmed.ncbi.nlm.nih.gov/42706201/#eng-abstract) [ Chinese ](https://pubmed.ncbi.nlm.nih.gov/42706201/#zho-abstract) Tuberculosis (TB) remains a major global public health problem. According to the World Health Organization (WHO) Global Tuberculosis Report 2025, an estimated 10.7 million people developed TB and approximately 1.23 million died from the disease in 2024. China continues to face a high burden of both TB and multidrug-resistant/rifampicin-resistant tuberculosis (MDR/RR-TB). The introduction and expanded use of new and repurposed anti-tuberculosis drugs, including bedaquiline and linezolid, together with accumulating evidence supporting all-oral shorter regimens, have resulted in evidence-based uses that are not yet fully reflected in current Chinese prescribing information. Meanwhile, off-label doses, treatment durations, and alternative uses of established anti-tuberculosis drugs and repurposed anti-infective agents, including isoniazid, rifamycins, fluoroquinolones, and carbapenems, are common in patients with complex drug resistance, drug intolerance, or other special clinical conditions. Standardized guidance is therefore needed within evidence-based, legal, and safety-monitoring frameworks.Building on the _Expert Consensus on Off-Label Use of Anti-Tuberculosis Drugs (2023 Update)_ , the Tuberculosis Branch of the Chinese Medical Association developed this guideline using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach and the Reporting Items for Practice Guidelines in Healthcare (RIGHT) statement. Focusing on 13 commonly used anti-tuberculosis drugs, the guideline systematically evaluates evidence regarding off-label indications, dosing, treatment duration, routes of administration, target populations, and safety monitoring. Comprehensive literature searches were conducted from database inception through June 10, 2025, and a total of 25 recommendations were formulated. Major updates in this guideline address newly approved and repurposed drugs and all-oral shorter regimens, optimized dosing and alternative applications of established agents, treatment considerations for children and patients with extrapulmonary tuberculosis, local drug administration, drug-safety monitoring, and therapeutic drug monitoring (TDM). The guideline aims to provide practical, standardized, and evidence-based recommendations to support the rational and safe off-label use of anti-tuberculosis drugs in clinical practice.The 25 recommendations are summarized as follows.**Recommendation 1:** Off-label use of anti-tuberculosis drugs should be supported by adequate medical evidence and limited to situations in which no appropriate approved alternative is available. Appropriate review and informed consent are required (1, B).**Recommendation 2:** An individualized safety monitoring plan should be developed according to drug-specific toxicities, patient characteristics, concomitant medications, and potential drug-drug interactions (1, B).**Recommendation 3:** High-dose isoniazid may be considered for patients with low-level isoniazid resistance and as a component of selected shorter regimens for MDR/RR-TB when isoniazid is likely to retain activity (2, C).**Recommendation 4:** Isoniazid, 10-15 mg/kg once daily, may be used for MDR/RR-TB with low-level resistance and retained activity (2, B). In selected cases of severe or refractory TBM, or when CNS exposure is inadequate, higher isoniazid dosing may be used; for children/adolescents, 15-20 mg/kg once daily with pyridoxine, toxicity monitoring, and TDM as needed (2, C).**Recommendation 5:** Local isoniazid administration may be cautiously and individually considered in selected cases as an adjunct to standardized systemic therapy, following specialist evaluation and appropriate safety monitoring (2, D).**Recommendation 6:** Where available, TDM may be considered for patients receiving high-dose isoniazid or those with an inadequate response, suspected malabsorption, clinically important drug interactions, a high risk of hepatotoxicity, or altered pharmacokinetics. NAT2 genotype-inferred acetylator phenotype may support individualized dose adjustment together with TDM, efficacy, and safety assessments (2, B).**Recommendation 7:** Off-label rifampicin use includes a 3-month regimen of isoniazid and rifampicin (3HR) (1, B) or a 4-month regimen of rifampicin (4R) (2, B) for tuberculosis preventive treatment; individualized high-dose use in TBM or investigational use in drug-susceptible pulmonary tuberculosis (2, C); local administration as adjunct therapy only (2, D); and use during pregnancy, including early pregnancy, after individualized benefit-risk assessment (2, C).**Recommendation 8:** Based on pharmacokinetic and safety data from Chinese populations, the 3H₂P₂ regimen-isoniazid 500-600 mg, plus rifapentine, 450-600 mg, twice weekly for 3 months-is recommended for tuberculosis preventive treatment (1, B).**Recommendation 9:** Levofloxacin is a key drug for fluoroquinolone-susceptible MDR/RR-TB (1, B); it may also be used for rifampicin-susceptible, isoniazid-resistant TB (2, D) or as an individualized alternative when first-line drugs cannot be used (2, C).**Recommendation 10:** Levofloxacin may be used in children of any age with MDR/RR-TB, and when first-line drugs cannot be used, as an individualized alternative for drug-susceptible TB. Dosing should be adjusted according to age and body weight, accompanied by appropriate safety monitoring (2, B).**Recommendation 11:** Oral levofloxacin administered once daily for 6 months is recommended for eligible close contacts of patients with MDR/RR-TB after active TB has been excluded and fluoroquinolone susceptibility of the source case has been assessed (1, B).**Recommendation 12:** Moxifloxacin may be used in fluoroquinolone-susceptible MDR/RR-TB (1, B). In drug-resistant TBM, individualized use may be considered, but 800 mg/day should not be routinely used (2, D). ECG and electrolyte monitoring is recommended during prolonged or high-dose use or concomitant QT-prolonging therapy (1, C).**Recommendation 13:** Fluoroquinolone TDM may be considered during high-dose or prolonged treatment or when drug exposure is uncertain. Levofloxacin Cmax 8-12 mg/L and moxifloxacin Cmax 3-5 mg/L are empirical reference ranges rather than fixed targets (2, B).**Recommendation 14:** Off-label linezolid use includes MDR/RR-TB, including pre-XDR-TB and XDR-TB (1, B); drug-resistant or refractory tuberculous meningitis (2, D); and eligible non-severe extrapulmonary MDR/RR-TB (2, C). Adults typically receive 600 mg once daily; children receive age-and weight-based dosing, with duration determined by the regimen (1, C).**Recommendation 15:** During prolonged linezolid treatment, monitoring should be performed for myelosuppression, optic and peripheral neuropathy, and lactic acidosis. The dose should be reduced, treatment interrupted, or linezolid discontinued according to toxicity severity, and concomitant serotonergic medications should be avoided whenever possible (1, B).**Recommendation 16:** TDM should be considered during prolonged linezolid treatment, particularly in patients with an inadequate response, serious toxicity, organ dysfunction, extreme body weight, or clinically important drug interactions (2, B).**Recommendation 17:** Contezolid may be considered as an alternative for patients with MDR/RR-TB who cannot tolerate linezolid or are at high risk of linezolid toxicity due to baseline myelosuppression, neurologic disease, or other factors, when an oxazolidinone is required to construct an effective regimen (2, D).**Recommendation 18:** Off-label clofazimine use includes longer MDR/RR-TB regimens as a WHO group B drug and selected 6-and 9-month regimens: its duration should follow the complete regimen and fluoroquinolone susceptibility results (1, B).**Recommendation 19:** Patients receiving clofazimine should be counseled regarding discoloration of the skin, mucosa, and body fluids and they should be monitored for gastrointestinal toxicity and Fridericia-corrected QT interval (QTcF) prolongation (1, B).**Recommendation 20:** Bedaquiline is a core drug for MDR/RR-TB. Off-label use includes adult RR-TB (2, C), children of any age with MDR/RR-TB (2, D), treatment beyond 24 weeks (2, C), use during pregnancy after benefit-risk assessment (2, C), and extrapulmonary MDR/RR-TB (2, C).**Recommendation 21:** During bedaquiline treatment, monitoring should be performed for QTcF prolongation, hepatic dysfunction, and other adverse reactions. More frequent ECG monitoring is recommended for older patients, those with underlying heart disease or electrolyte abnormalities, and those receiving concurrent QT-prolonging medications (1, B).**Recommendation 22:** Off-label delamanid use includes adult RR-TB as part of an appropriate combination regimen (2, C), children of any age with MDR/RR-TB (2, D), treatment extending beyond 24 weeks (2, C), use during pregnancy after benefit-risk assessment (2, C), and extrapulmonary MDR/RR-TB (2, C). Monitoring of QTcF interval, electrolytes, and serum albumin is required; its use should be avoided if the baseline serum albumin is <28 g/L (1, B).**Recommendation 23:** Amikacin may be considered for selected MDR/RR-TB, retreatment TB, or TB requiring regimen modification due to drug intolerance, and for severe, refractory, or drug-resistant TBM during the intensive phase (2, C). Local administration may be used as adjunctive therapy in selected cases (2, D).**Recommendation 24:** Monitor renal function, urinalysis, and auditory/vestibular function during amikacin treatment. Adjust the dose or dosing interval for renal impairment. TDM is advised when available, particularly for high-risk or prolonged treatment, to support individualized dosing (1, B).**Recommendation 25:** Meropenem or imipenem/cilastatin, each combined with clavulanate, may be considered as a Group C option for MDR/RR-TB when Group A and B drugs cannot form an effective regimen (2, D). In drug-resistant, severe, or refractory TBM, individualized use may be considered only when other effective options are unavailable; meropenem is preferred for children and patients at high risk of seizures (2, D). 结核病仍然是全球重大的公共卫生问题。根据世界卫生组织（WHO）《2025年全球结核病报告》，2024年度全球估算新发患者约1 070万例、死亡人数约123万例。我国同时面临结核病和耐多药/利福平耐药结核病（MDR/RR-TB）的较高疾病负担。超说明书用药是指药品使用的适应证、给药剂量、给药途径、疗程或适用人群等超出药品监督管理部门批准的说明书推荐范围的用法。随着贝达喹啉、利奈唑胺等抗结核新药上市及全口服短程方案证据不断更新，部分已被权威指南推荐的新药、新方案及特殊人群的用法未及时纳入我国现行药品说明书。同时，异烟肼、利福霉素、氟喹诺酮类及碳青霉烯类等药物在复杂耐药、药物不耐受及特殊人群中的超剂量、超疗程应用较为普遍。上述临床实践亟需在循证医学、法律规范和安全监测框架下予以规范。中华医学会结核病学分会在《抗结核药物超说明书用法专家共识（2023年更新版）》的基础上，围绕13种常用抗结核药物的超说明书适应证、剂量、疗程、给药途径、适用人群及安全监测问题，采用推荐意见分级的评估、制订及评价（GRADE）体系和国际实践指南报告标准（RIGHT），系统评价了现有证据，形成了25条推荐意见。指南重点更新新药和全口服短程方案、传统药物优化剂量与替代应用、儿童及肺外结核用药、局部给药、药物安全监测和治疗药物监测（TDM），旨在为抗结核药物超说明书使用提供规范、可操作的循证依据。. [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## Conflict of interest statement 所有作者声明无利益冲突 ## Similar articles * [ [Chinese guideline for the chemotherapy of multidrug-resistant/rifampicin-resistant tuberculosis (2026 edition)]. ](https://pubmed.ncbi.nlm.nih.gov/42236454/) Chinese Society of Tuberculosis, Chinese Medical Association.Chinese Society of Tuberculosis, Chinese Medical Association.Zhonghua Jie He He Hu Xi Za Zhi. 2026 Jun 12;49(6):623-643. doi: 10.3760/cma.j.cn112147-20251104-00674.Zhong
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