The CDC’s Division of TB Elimination (DTBE) has released provisional guidelines for the use and safety monitoring of bedaquiline in the treatment of multidrug-resistant tuberculosis (MDR-TB).
MDR-TB is caused by Mycobacterium tuberculosis that is resistant to at least isoniazid and rifampin. MDR-TB requires 18–24 months of treatment after sputum culture conversion with a regimen that consists of 4–6 agents with toxic side effects – carrying a mortality risk greater than drug-susceptible TB.
Sirturo (bedaquiline fumarate; Janssen), a diarylquinoline, was approved as part of combination therapy (>4 drug therapy) in pulmonary MDR-TB only when an effective treatment regimen cannot otherwise be provided. It was granted accelerated approval on December 28, 2012 by the FDA.
The following are intended for healthcare professionals who might use bedaquiline for the treatment of MDR-TB for indicated and off-label uses. Clinicians should exercise judgment in management decisions modified as clinically indicated for unique patient circumstances:
- Bedaquiline may be used for 24 weeks of treatment in adults with laboratory-confirmed pulmonary MDR-TB (TB with an isolate showing genotypic or phenotypic resistance to both isoniazid and rifampin) when an effective treatment regimen cannot otherwise be provided
- Bedaquiline may be used on a case-by-case basis in children, HIV-infected persons, pregnant women, persons with extrapulmonary MDR-TB, and patients with comorbid conditions on concomitant medications when an effective treatment regimen cannot otherwise be provided
- Bedaquiline may be used on a case-by-case basis for durations longer than 24 weeks when an effective treatment regimen cannot be provided otherwise
Additional considerations regarding dosing and administration, monitoring, precautions, monitoring for adverse events, and training, education, and medical consultation are also listed in further detail in this week’s Morbidity and Mortality Weekly Report (MMWR).
For more information call (800) 232-4636 or visit CDC.gov/MMWR.