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Bedaquiline oral

Updated 2 Feb 2023 | Other antituberculosis drugs


Oral formulations of bedaquiline.

Drugs List

  • bedaquiline 100mg tablets
  • SIRTURO 100mg tablets
  • Therapeutic Indications


    Pulmonary multidrug-resistant tuberculosis

    For use as part of combination therapy for pulmonary multidrug-resistant tuberculosis (MDR-TB) when an effective treatment regimen cannot otherwise be composed due to resistance or tolerability.

    Bedaquiline must only be used in an appropriate combination regimen for MDR-TB treatment as recommended by official guidelines, such as from WHO, to prevent development of resistance to bedaquiline.

    The manufacturer suggests administering bedaquiline by directly observed therapy (DOT).


    Must be used in combination with at least three medicinal products to which the patient's isolate has shown to be susceptible in vitro. Treatment with other agents in the regimen should continue after completion of treatment with bedaquiline. If in vitro results are not available, treatment may be initiated with bedaquiline in combination with at least four medicinal products to which the patient's isolate is likely to be susceptible.

    Duration of treatment is 24 weeks. In cases of extensive drug resistance, treatment beyond 24 weeks to obtain curative treatment may be considered on a case by case basis and under close safety surveillance.


    Weeks 1 to 2
    400mg once daily.

    Weeks 3 to 24
    200mg three times per week with at least 48 hours between doses.


    Children aged 12 to 18 years and weighing at least 30kg

    Weeks 1 to 2

    400mg once daily.

    Weeks 3 to 24

    200mg three times per week with at least 48 hours between doses.

    Additional Dosage Information

    Missed doses
    Advise patient if a dose is missed during the first 2 weeks of treatment, patient should not make up the missed dose but should continue the usual dosing schedule.

    Advise patient if a dose is missed from week 3 onwards, patients should take the missed dose of 200mg as soon as possible and then resume the 3 times a week regimen.


    Children under 12 years
    Children weighing less than 30kg
    Long QT syndrome
    QTc interval greater than or equal to 500 msec
    Severe hepatic impairment
    Torsade de pointes
    Ventricular arrhythmias

    Precautions and Warnings

    Family history of long QT syndrome
    Patients over 65 years
    QTcF interval greater than 450msec at baseline
    Cardiac failure
    Congenital long QT syndrome
    Electrolyte imbalance
    End stage renal disease
    Glucose-galactose malabsorption syndrome
    History of torsade de pointes
    Lactose intolerance
    Moderate hepatic impairment
    Renal impairment - creatinine clearance below 30 ml/minute

    Correct electrolyte disorders before treatment
    Advise ability to drive/operate machinery may be affected by side effects
    Consult national/regional policy on the use of anti-infectives
    Must be used in combination with other anti-tuberculous drugs
    Treatment to be initiated and supervised by a specialist
    Contains lactose
    Advise patient to take with or after food
    Monitor ECG before initiating and at least monthly thereafter
    Monitor hepatic function before initiating and at monthly intervals
    If syncope occurs obtain an ECG to detect QT prolongation
    Monitor patients on prolonged therapy
    Monitor serum electrolytes
    Consider discontinuing treatment if ALT/AST > 5 times upper limit of normal
    Discontinue treatment if arrhythmias occur
    Discontinue treatment if QTc exceeds 500msec
    Advise patient not to take St John's wort concurrently
    Advise patient to avoid alcohol during treatment
    Advise patients on the importance of taking treatment regularly

    In adolescents weighing between 30 and 40kg, average bedaquiline exposure is predicted to be higher compared to adult patients. This may be associated with an increased risk of QT prolongation or hepatotoxicity.

    Pregnancy and Lactation


    Use bedaquiline with caution during pregnancy.

    The manufacturer suggests bedaquiline should be avoided during pregnancy unless the benefit of therapy outweighs the risks.

    At the time of writing, there are limited data on the use of bedaquiline in pregnant women. At clinically relevant exposures, animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.


    Bedaquiline is contraindicated during breastfeeding.

    The manufacturer suggests, because of the potential for adverse effects in breastfed infants, a decision must be made whether to discontinue breastfeeding or to discontinue bedaquiline therapy taking into account the benefit of therapy and the benefit of breastfeeding the infant.

    It is not known whether bedaquiline or its metabolites are excreted in human milk. In rats, milk concentrations of bedaquiline were 6 to 12-fold higher than the maximum concentration observed in maternal plasma. Bodyweight decreases in pups were observed in high dose groups during the lactation period.

    Side Effects

    Increase of liver transaminases
    Prolongation of QT interval


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: October 2020

    Reference Sources

    Summary of Product Characteristics: Sirturo 100 mg tablets. Janssen-Cilag Ltd. January 2020.

    NICE Evidence Services Available at: Last accessed: 07 October 2020

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