Drug updated on 4/15/2024
| Dosage Form | Tablet (oral; 20 mg, 100 mg) |
| Drug Class | Diarylquinoline antimycobacterials |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated as part of combination therapy in adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary multi-drug resistant tuberculosis (MDR-TB). Reserve SIRTURO for use when an effective treatment regimen cannot otherwise be provided.
Summary
- Bedaquiline (Sirturo) is indicated as part of combination therapy in adult and pediatric patients with pulmonary multi-drug resistant tuberculosis (MDR-TB), particularly when an effective treatment regimen cannot otherwise be provided.
- Eighteen systematic reviews/meta-analyses were examined to gather information about the safety and efficacy of bedaquiline compared to other drugs for treating MDR-TB.
- One study highlighted that bedaquiline contributed to a shorter sputum culture conversion time in DR-TB patients, marking an important metric of treatment effectiveness. Various factors like patient demographics and baseline health status influence this outcome.
- Results showed reasonable rates of culture conversion at six months when comparing bedaquiline with delamanid or their combined use. Bedaquiline held a slight edge in efficacy when used alone.
- The incidence rate for adverse events varied across studies, but QTc prolongation was identified as a significant concern associated with bedaquiline treatment. Despite this, serious adverse events necessitating discontinuation were relatively low, which supports its safety profile for treating MDR/XDR TB cases.
- Compared to other drugs such as Kanamycin or combinations thereof, bedaquiline demonstrated fewer adverse effects along with better overall outcomes, presenting a favorable option.
- For subgroups co-infected by HIV alongside DR-TB, regimens containing bedaquiline have been observed to contribute to higher success rates, thus emphasizing its importance within these vulnerable population groups.
- Bedaquiline's role becomes critical in managing complex pre-XDR/TD & XDR/TD cases, especially where limited treatment options are available due to a high burden among MDR-TB instances.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Sirturo (bedaquiline) Prescribing Information. | 2023 | Janssen Therapeutics, Titusville, NJ |