Active Ingredient: Bedaquiline
Bedaquiline is indicated for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR-TB) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 400 milligrams bedaquiline, once daily to meals, over the duration of 2 weeks. Afterwards, oral, 200 milligrams bedaquiline, 3 times weekly to meals, over the duration of 22 weeks.
The recommended dosage for bedaquiline in adult (18 years and older) patients is shown below.
Recommended dosage of bedaquiline in adult patients:
| Population | Dosing Recommendation | |
|---|---|---|
| Weeks 1 to 2 | Weeks 3 to 24a | |
| Adults (18 years and older) | 400 mg orally once daily | 200 mg orally three times per week |
a = At least 48 hours between doses
The total duration of treatment with bedaquiline is 24 weeks. Data on longer treatment duration is very limited. When treatment with bedaquiline is considered necessary beyond 24 weeks to obtain a curative treatment, a longer duration of therapy may be considered under close safety surveillance.
Patients should be advised to take bedaquiline exactly as prescribed and to complete the full course of therapy.
If a dose is missed during the first two weeks of treatment, patients should not make up the missed dose, but should continue the usual dosing schedule.
If a dose is missed from week three onwards, patients should take the missed dose as soon as possible and then resume the three times a week regimen. The total dose of bedaquiline during a 7 day period should not exceed the recommended weekly dose (with at least 24 hours between each intake).
Bedaquiline should be taken orally with food, as administration with food increases oral bioavailability by about 2-fold.
For:
Regimen A: In case that patient weight is ≥ 15 kg and patient weight is ≤ 20 kg, oral, 160 milligrams bedaquiline, once daily to meals, over the duration of 2 weeks. Afterwards, in case that patient weight is ≥ 15 kg and patient weight is ≤ 20 kg, oral, 80 milligrams bedaquiline, 3 times weekly to meals, over the duration of 22 weeks.
Regimen B: In case that patient weight is ≥ 20 kg and patient weight is ≤ 30 kg, oral, 200 milligrams bedaquiline, once daily to meals, over the duration of 2 weeks. Afterwards, in case that patient weight is ≥ 20 kg and patient weight is ≤ 30 kg, oral, 100 milligrams bedaquiline, 3 times weekly to meals, over the duration of 22 weeks.
Regimen C: In case that patient weight is ≥ 30 kg, oral, 400 milligrams bedaquiline, once daily to meals, over the duration of 2 weeks. Afterwards, in case that patient weight is ≥ 30 kg, oral, 200 milligrams bedaquiline, 3 times weekly to meals, over the duration of 22 weeks.
The recommended dosage for bedaquiline in paediatric patients (5 years to less than 18 years of age) is based on body weight and shown in the following table.
Recommended dosage of bedaquiline in paediatric patients (5 years to less than 18 years of age):
| Body Weight | Dosage Recommendation | |
|---|---|---|
| Weeks 1 to 2 | Weeks 3 to 24a | |
| Greater than or equal to 15 kg to less than 20 kg | 160 mg orally once daily | 80 mg orally three times per week |
| Greater than or equal to 20 kg to less than 30 kg | 200 mg orally once daily | 100 mg orally three times per week |
| Greater than or equal to 30 kg | 400 mg orally once daily | 200 mg orally three times per week |
a = At least 48 hours between doses
The total duration of treatment with bedaquiline is 24 weeks. Data on longer treatment duration is very limited. When treatment with bedaquiline is considered necessary beyond 24 weeks to obtain a curative treatment, a longer duration of therapy may be considered under close safety surveillance.
Patients should be advised to take bedaquiline exactly as prescribed and to complete the full course of therapy.
If a dose is missed during the first two weeks of treatment, patients should not make up the missed dose, but should continue the usual dosing schedule.
If a dose is missed from week three onwards, patients should take the missed dose as soon as possible and then resume the three times a week regimen. The total dose of bedaquiline during a 7 day period should not exceed the recommended weekly dose (with at least 24 hours between each intake).
Bedaquiline should be taken orally with food, as administration with food increases oral bioavailability by about 2-fold.
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