Diarylquinoline antimycobacterial (MDR-TB) Pregnancy: Limited data in pregnant women; as a precautionary measure avoid use during pregnancy unless benefit outweighs risks. Bedaquiline is excreted in human milk at higher concentrations than maternal plasma — women treated with bedaquiline should not breastfeed.

Bedaquiline

Brand names: Sirturo

Bedaquiline is an oral diarylquinoline antimycobacterial used as part of combination regimens for multidrug-resistant pulmonary tuberculosis.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Weeks 1-2: 400 mg once daily. Weeks 3-24: 200 mg three times per week (at least 48 hours between doses)

Route: Oral (with food)

Frequency: Once daily for first 2 weeks, then three times per week

Product: Sirturo (adults 18 years and older). Total duration of treatment is 24 weeks. When treatment beyond 24 weeks is considered necessary, may be continued up to 40 weeks in adults at 200 mg three times per week. Initiate and monitor under a physician experienced in managing TB resistant to at least rifampicin and isoniazid; consider WHO guidelines for the combination regimen. Only use in combination with other medicinal products to which the isolate is (or is likely) susceptible. Administer by directly observed therapy (DOT); take with food (increases bioavailability ~2-fold); swallow 100 mg tablets whole with water. Paediatric dosing (2 to <18 years, at least 7 kg) is by body-weight band per SPC Table 2 — verify against a children's formulary. Do not exceed the recommended weekly dose over any 7-day period.

Dose adjustments

Renal

No dose adjustment in mild or moderate renal impairment. In severe renal impairment (creatinine clearance <30 mL/min) or end-stage renal disease requiring haemodialysis or peritoneal dialysis, use with caution.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance or to any of the excipients

Side effects

Nausea, vomiting (very common)
Headache, dizziness (very common)
Transaminases increased (very common)
Arthralgia (very common)
Electrocardiogram QT prolonged (very common)

Interactions

Additive QT prolongation expected with other QTc-prolonging medicinal products (including clofazimine, delamanid or fluoroquinolones)
Strong and moderate CYP3A4 inducers may decrease bedaquiline exposure — avoid coadministration (per US labelling)
CYP3A4 inhibitors increase bedaquiline exposure — closely monitor patient safety e.g. liver function (per US labelling)

Clinical monograph

How it works

It inhibits mycobacterial ATP synthase, depriving Mycobacterium tuberculosis of the energy needed for survival and replication.

Prescribing in practice

Bedaquiline prolongs the QT interval and this effect is additive with other QT-prolonging agents, so an ECG-based assessment is essential before and during treatment.
It must only be used within a supervised combination regimen agreed with a tuberculosis specialist service to protect against resistance.
Hepatic transaminase elevations occur, and concomitant strong CYP3A4 inducers or inhibitors meaningfully alter exposure.

Monitoring

Monitor the ECG (QT interval) and liver function tests at baseline and periodically throughout treatment, alongside serum potassium, calcium and magnesium.

Counselling the patient

Take this medicine with food and exactly as directed, never stopping early or missing doses.
Tell the team about any palpitations, fainting or yellowing of the skin or eyes.
Avoid alcohol and report all other medicines you take, as several can interact.

Evidence & guidelines

Regimen-based use is supported by World Health Organization guidance on the treatment of drug-resistant tuberculosis.

Reference: WHO MDR-TB; BTS/SIGN; UKHSA; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Pathways