bedaquiline
Sirturo · ATC code J04AK05
Also known as: Bedaquilin, Bedakilin
- Key facts
- Active substance
- bedaquiline
- Drug class
- Antituberculous drug
- ATC code
- J04AK05
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- SIRTURO 20 mg tablets / SIRTURO 100 mg tablets
- Marketing authorisation holder
- 6547
- Information as of
- 2026-10-28
Key facts
Bedaquiline is an antituberculosis agent (diarylquinoline) used as part of combination therapy for pulmonary tuberculosis resistant to at least rifampicin and isoniazid (Sirturo).
What it is used for
- Part of an appropriate combination regimen in adults and children (2 to less than 18 years, at least 7 kg) with pulmonary TB due to Mycobacterium tuberculosis resistant to at least rifampicin and isoniazid.
Dosing
- Adults: weeks 1 to 2, 400 mg once daily; weeks 3 to 24, 200 mg three times per week (at least 48 hours between doses); take with food.
- Children from 2 years: dosing by body weight (e.g. from 30 kg as for adults); details: see the full text.
- Total treatment duration 24 weeks; in adults, treatment may be continued up to 40 weeks at 200 mg three times per week if necessary.
- Only in combination with other effective medicines; directly observed therapy (DOT) is recommended.
- A dose missed in the first two weeks should not be made up; from week three, take it as soon as possible.
- Mild or moderate hepatic or renal impairment: no dose adjustment; severe hepatic impairment: not recommended; severe renal impairment (creatinine clearance <30 mL/min) or dialysis: use with caution.
Contraindications
- Hypersensitivity to the active substance or any excipient.
Important warnings
- QT prolongation: ECG before starting and at least monthly; check and correct potassium, calcium and magnesium at baseline. Discontinue for clinically significant ventricular arrhythmia or QTcF >500 ms.
- Initiation not recommended with heart failure, QTcF >450 ms, congenital QT prolongation, hypothyroidism, bradyarrhythmia, history of Torsade de Pointes or hypokalaemia, unless benefits outweigh risks.
- Hepatic safety: monitor transaminases, alkaline phosphatase and bilirubin at baseline and monthly; if AST or ALT exceeds 5 times the upper limit of normal, review the regimen. Avoid alcohol and other hepatotoxic medicines.
- Use only in an appropriate combination to prevent resistance; no data in extra-pulmonary or latent TB.
Side effects
- Most frequent in the Phase III trial: QT prolongation (61%), nausea (54%), vomiting (54%), arthralgia (45%), transaminases increased (30%), dizziness (18%) and headache (17%).
- Very common: headache, dizziness; other reactions: see the full text.
Interactions
- Moderate or strong CYP3A4 inducers (e.g. efavirenz, etravirine, rifampicin, rifapentine, rifabutin, carbamazepine, phenytoin, St. John's wort) reduce bedaquiline exposure and should be avoided.
- CYP3A4 inhibitors: no clinically relevant effect; no dose adjustment needed.
- Other QTc-prolonging medicines (e.g. clofazimine, delamanid, fluoroquinolones): an additive effect on QT prolongation is expected.
Pregnancy and breastfeeding
- As a precaution, avoid during pregnancy unless the benefit outweighs the risks.
- Bedaquiline is excreted in human milk; women treated with it should not breastfeed.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- Sirturo6547 · EMEA/H/C/002614
Source: European Medicines Agency (EMA), product information
Turkey
- SirturoJOHNSON AND JOHNSON SIHHİ MAL. SAN. VE TİC. LTD. ŞTİ. · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 3 more European countries
- Iceland
- Sirturo
- Liechtenstein
- Sirturo
- Norway
- Sirturo
EMA – Article 57 product data (EU/EEA), 2026-10-29
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Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Sirturo – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/sirturo-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC J04AK.
Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.