Drug updated on 4/18/2024
| Dosage Form | Tablet (oral; 200 mg) |
| Drug Class | Antimycobacterials |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary extensively drug resistant (XDR), treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB).
Summary
- Pretomanid is indicated as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary extensively drug-resistant, treatment-intolerant, or non-responsive multidrug-resistant tuberculosis.
- Four systematic reviews/meta-analyses addressed the use of pretomanid in tuberculosis treatment. The studies suggest that regimens containing pretomanid significantly increase the chance of a favorable outcome in DR-TB patients, showing superior early bactericidal activity and high rates of favorable outcomes.
- A significant concern raised by these studies about pretomanid is hepatotoxicity, leading to serious adverse events when used in certain combinations. This underscores the need for cautious monitoring during its usage.
- Frequent linezolid-related toxicity was also reported among patients treated with a specific regimen involving pretomanid, highlighting balanced consideration between efficacy and toxicity while choosing treatments.
- Compared to other drugs, Pretomanid offers strong bactericidal activity potentially bettering treatment outcomes than some other regimens but carries risks such as hepatotoxicity, requiring careful patient selection and monitoring.
- While specifics on different population subgroups are not detailed extensively in these studies, it's suggested that patients with highly resistant TB respond well to Pretomanid-based regimens indicating potential benefits, particularly for this subset albeit under careful watch on adverse effects.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Pretomanid Prescribing Information. | 2019 | The Global Alliance for TB Drug Development., New York, NY |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Relapse after treatment with standardized all-oral short regimens for rifampicin-resistant tuberculosis (RR-TB): a systematic review and meta-analysis. | 2024 | Journal of Clinical Tuberculosis and Other Mycobacterial Diseases |
| Efficacy of pretomanid-containing regiments for drug-resistant tuberculosis: a systematic review and meta-analysis of clinical trials. | 2023 | Narra J |
| Pretomanid for tuberculosis: a systematic review. | 2022 | Clinical Microbiology and Infection |
| Systematic review of mutations associated with resistance to the new and repurposed mycobacterium tuberculosis drugs bedaquiline, clofazimine, linezolid, delamanid and pretomanid. | 2020 | Journal of Antimicrobial Chemotherapy |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| WHO consolidated guidelines on tuberculosis: Module 4: treatment - drug-resistant tuberculosis treatment, 2022 update [Internet]. | 2022 | World Health Organization |
| WHO consolidated guidelines on tuberculosis: module 4: treatment - drug-resistant tuberculosis treatment. | 2020 | World Health Organization |