Skip to content

Bedaquiline

    Brands

    DEA Class; Rx

    Common Brand Names; Sirturo

    • Antitubercular Agents

    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

    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

    —

    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%)

    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

    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)

    Adults

    400 mg/day PO.

    Geriatric

    400 mg/day PO.

    Adolescents

    weighing 30 kg or more: 400 mg/day PO.
    weighing 15 to 29 kg: 200 mg/day PO.

    Children

    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.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Bedaquiline

    tablet

    • 20mg (functionally scored)
    • 100mg