Classes
DEA Class; Rx
Common Brand Names; Sirturo
- Antitubercular Agents
Description
Diarylquinoline antimycobacterial
For use in combination with other drugs to treat adults and pediatric patients 5 years and older weighing at least 15 kg with pulmonary multi-drug resistant tuberculosis (MDR-TB) for which no other effective treatment regimens are available
Associated with an increased risk of death in adults and QT prolongation
Indications
Diarylquinoline antimycobacterial indicated as part of combination therapy for pulmonary multidrug resistant tuberculosis (MDR-TB); reserve bedaquiline for when an effective treatment TB regimen cannot otherwise be provided
Only use in combination with at least 3 other drugs to which the patient’s MDR-TB isolate has been shown to be susceptible in vitro; if in vitro testing results are unavailable, may be initiated in combination with at least 4 other drugs to which the patient’s MDR-TB isolate is likely to be susceptible
Limitations of use
- Latent infection due to Mycobacterium tuberculosis
- Drug-sensitive tuberculosis
- Extra-pulmonary tuberculosis
- Infections cause by nontuberculous mycobacteria
Nontuberculosis Mycobacteria Infection (Orphan)
Orphan designation for treatment of nontuberculosis mycobacteria infection
Adverse Effects
Adults
- Nausea (38%)
- Arthralgia (33%)
- Headache (28%)
- Chest pain (11%)
- Anorexia (9%)
- Rash (8%)
Pediatrics
- Arthralgia (40%)
- Nausea (13%)
- Abdominal pain (13%)
Adults or children
- Transaminases increased (9%)
- Blood amylase increased (3%)
Warnings
Increased risk of death in bedaquiline treatment group
Administered by directly observed therapy (DOT)
Potential for development of resistance to bedaquiline in M tuberculosis exists; must only be used in an appropriate combination regimen fo treatment of pulmonary MDR-TB to reduce risk of developing resistance
Pregnancy and Lactation
Available data from published literature of use in pregnant women are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
No data are available regarding presence in human milk
Monitor infants exposed for signs of bedaquiline-related adverse reactions (eg, hepatotoxicity)
Maximum Dosage
400 mg/day PO.
400 mg/day PO.
weighing 30 kg or more: 400 mg/day PO.
weighing 15 to 29 kg: 200 mg/day PO.
5 to 12 years weighing 30 kg or more: 400 mg/day PO.
5 to 12 years weighing 15 to 29 kg: 200 mg/day PO.
5 to 12 years weighing less than 15 kg: Safety and efficacy have not been established.
1 to 4 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Bedaquiline
tablet
- 20mg (functionally scored)
- 100mg
