Dosage and Administration

Administer SIRTURO® (bedaquiline) by directly observed therapy (DOT). SIRTURO® tablets should only be administered as part of a pulmonary multi-drug resistant tuberculosis (MDR-TB) regimen. Reserve SIRTURO® for use when an effective treatment regimen cannot otherwise be provided.

  • Only use SIRTURO® 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, treatment may be initiated with SIRTURO® in combination with at least 4 other drugs to which the patient’s isolate is likely to be susceptible.

SIRTURO® should be swallowed whole with water and taken with food.

Prior to treatment with SIRTURO®, obtain the following:

  • Susceptibility information for the background regimen against M. tuberculosis isolate if possible
  • ECG
  • Serum potassium, calcium, and magnesium concentrations
  • Liver enzymes

See Table 1 for the recommended dosage of SIRTURO® in adult and pediatric patients (12 to less than 18 years of age).

Table 1: Recommended Dosage of SIRTURO®

PopulationDosage
Adult patients (18 years of age and older)400 mg orally once daily for the first two weeks, followed by 200 mg orally three times per week (with at least 48 hours between doses) for 22 weeks (total duration of 24 weeks)
Pediatric patients (12 to less than 18 years of age) and weighing at least 30 kg

The total duration of treatment with SIRTURO® is 24 weeks

Compliance with the full course of therapy must be emphasized.

Missed Doses

If a dose is missed during the first 2 weeks of treatment, do not administer the missed dose (skip the dose and then continue the daily dosing regimen).

From Week 3 onwards, if a 200-mg dose is missed, administer the missed dose as soon as possible, and then resume the 3-times-a-week regimen.