Antituberculous Agents — 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 under specialist supervision.

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). Indicated as part of an appropriate combination regimen for pulmonary TB due to M. tuberculosis resistant to at least rifampicin and isoniazid. Total duration of treatment is 24 weeks; may be continued up to 40 weeks in adults at 200 mg three times per week when necessary. Initiate and monitor under a physician experienced in managing resistant TB; consider WHO guidelines. 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 it needs to survive and replicate.

Prescribing in practice

Most important: it prolongs the QT interval, so obtain a baseline ECG and serum electrolytes, monitor the ECG during treatment, and review co-administered QT-prolonging drugs per MHRA advice.
It must only be used within an appropriate multidrug regimen to prevent emergence of resistance, never as monotherapy.
Monitor liver function, as hepatotoxicity has been reported, and avoid additional hepatotoxins where possible.

Monitoring

Monitor with serial ECGs for QT prolongation, electrolytes, and liver function throughout the prolonged course.

Counselling the patient

Take it with food and exactly as directed, completing the full multidrug course.
Report fainting, palpitations, or yellowing of the skin or eyes promptly.

Evidence & guidelines

Bedaquiline is recommended within WHO and national MDR-TB regimens based on trials demonstrating improved culture conversion.

Reference: NICE NG33; WHO TB Guidelines 2022; STREAM trial; OPTIC trial; ZeNix trial NEJM 2022; MHRA SPC Sirturo; 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.

Drugs

Delamanid · Antituberculous Agents — MDR-TB

Pathways