- Treatment of pulmonary MDR TB (resistant to at least INH and rifampin) in combination with other active antimycobacterial agents (minimum of four-drug treatment regimen) when an effective treatment regimen cannot otherwise be provided.
- Limitation of use: the safety and efficacy of bedaquiline for the treatment of latent infection due to Mycobacterium tuberculosis or drug-sensitive TB has not been established.
- In addition, there are limited data on the treatment of extra-pulmonary TB (e.g., central nervous system).
NON-FDA APPROVED USES
- On a case-by-case basis bedaquiline can be considered in extra-pulmonary TB, children, pregnant women, and HIV-infected patients when an effective anti-TB cannot be provided otherwise (CDC recommendation)
- Treatment of MAC and M. abscessus when there are no other alternatives
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