Drug updated on 10/29/2024
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).
Latest News
Summary
- This summary is based on the review of six systematic review(s)/meta-analysis(es). [1-6]
- A systematic review and meta-analysis found a pooled relapse proportion of 2.0% (95% CI, 1.0-3.0%) for short all-oral regimens treating rifampicin-resistant tuberculosis (RR-TB), indicating effective management of this condition.
- In patients with drug-resistant tuberculosis (DR-TB), 204 out of 237 (86%) had favorable outcomes with pretomanid-containing regimens, yielding an odds ratio (OR) of 46.73 (95% CI: 11.76-185.7), suggesting significant efficacy in this population.
- Pretomanid-moxifloxacin-pyrazinamide demonstrated superior early bactericidal activity in rifampicin-susceptible tuberculosis; however, this regimen was halted due to serious hepatotoxic adverse events, underscoring the importance of safety monitoring in treatment protocols.
- Adverse events were reported more frequently in patients receiving higher cumulative doses of linezolid in BPaL regimens, with 35% of those on 1200 mg daily experiencing grade 3-4 adverse events, compared to 22% receiving 600 mg daily.
- The pretomanid-moxifloxacin-pyrazinamide regimen was halted due to serious hepatotoxic adverse events, including three deaths, indicating significant safety concerns associated with this treatment.
- Studies included patients with rifampicin-resistant tuberculosis (RR-TB), drug-resistant tuberculosis (DR-TB), and highly resistant tuberculosis. Pretomanid-containing regimens showed low relapse rates and high favorable outcomes (204 out of 237 patients, 86% cured) in these populations, while also revealing safety concerns such as frequent linezolid-related toxicity in highly resistant cases.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Pretomanid (pretomanid) Prescribing Information. | 2022 | Mylan Specialty L.P., Morgantown, WV |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
WHO consolidated guidelines on tuberculosis: module 4: treatment - drug-resistant tuberculosis treatment. | 2020 | World Health Organization |