Bedaquiline is a diarylquinoline antimycobacterial agent indicated for use in combination therapy for pulmonary tuberculosis caused by Mycobacterium tuberculosis resistant to at least rifampicin and isoniazid, in adults and children aged 2 years and older with a body weight of at least 8 kg.

Recommended Dosage of Bedaquiline

Recommended Dosage for Adult Patients

Initial Phase (Weeks 1–2): 400 mg orally once daily (equivalent to 4 tablets of 100 mg strength or 20 tablets of 20 mg strength).

Maintenance Phase (Weeks 3–24): Switch to 200 mg three times weekly (equivalent to 2 tablets of 100 mg strength or 10 tablets of 20 mg strength), with an interval of at least 48 hours between each dose.

Total Treatment Duration: The full course of bedaquiline treatment is 24 weeks. If continued treatment is required beyond 24 weeks, extension with a dosage of 200 mg three times weekly may be considered.

Recommended Dosage for Pediatric Patients (≥ 2 years old and ≥ 8 kg body weight)

Pediatric dosage must be strictly calculated based on body weight, also divided into a 2-week initial phase and a 22-week maintenance phase.

Body weight 8 kg to less than 10 kg: 80 mg once daily (4 tablets of 20 mg strength) during the initial phase; 40 mg three times weekly (2 tablets of 20 mg strength) during the maintenance phase.

Body weight 10 kg to less than 15 kg: 120 mg once daily (6 tablets of 20 mg strength) during the initial phase; 60 mg three times weekly (3 tablets of 20 mg strength) during the maintenance phase.

Body weight 15 kg to less than 30 kg: 200 mg once daily (2 tablets of 100 mg strength or 10 tablets of 20 mg strength) during the initial phase; 100 mg three times weekly (1 tablet of 100 mg strength or 5 tablets of 20 mg strength) during the maintenance phase.

Body weight ≥ 30 kg: The dosage is the same as that for adults.

Administration Method

All formulations must be taken with food to enhance bioavailability.

100 mg tablets: Swallow the tablet whole with water.

20 mg tablets: Flexible administration is allowed based on the patient's condition: the tablet can be swallowed whole with water or split along the functional score into two halves (10 mg per half) and taken with water.

For patients with difficulty swallowing, the tablet can be dispersed in water and taken immediately. Alternatively, it can be further mixed with beverages (such as water, milk, fruit juice) or soft foods (such as yogurt, applesauce) before administration.

The tablet can also be crushed and mixed with soft food for ingestion.

Management of Missed Doses

Missed dose during the first 2 weeks of treatment: Skip the missed dose and take the next dose as scheduled. Do not take a double dose to make up for the missed one.

Missed dose from week 3 onwards: Take the missed dose as soon as possible, then resume the three-times-weekly dosing schedule.

Ensure that the total weekly dose does not exceed the recommended weekly dosage within 7 days, and the interval between each dose is at least 24 hours.

Use in Special Populations

Patients with Hepatic Impairment

Mild to moderate hepatic impairment (Child-Pugh Class A or B): No dosage adjustment is required.

Severe hepatic impairment (Child-Pugh Class C): No clinical studies have been conducted. Use with caution, and only consider administration when the benefits outweigh the risks, with close monitoring for adverse reactions.

Patients with Renal Impairment

Mild to moderate renal impairment: No dosage adjustment is required.

Severe renal impairment or end-stage renal disease requiring dialysis: Use with caution. Bedaquiline is minimally excreted via the kidneys, but severe renal impairment may indirectly alter drug concentrations by affecting absorption, distribution, and metabolism. Hemodialysis or peritoneal dialysis does not significantly remove the drug.

Pregnancy and Lactation

Pregnancy: Available data are insufficient to evaluate the risk. However, active tuberculosis itself poses a definite risk to pregnancy, so the potential benefits and risks must be carefully weighed.

Lactation: Breastfeeding is not recommended, as the drug accumulates in breast milk.