Bedaquiline

What it is and how it works

Mechanism of Action Bedaquiline is a diarylquinoline antimycobacterial drug .

Indications

is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in the treatment of adult and pediatric patients (2 years and older and weighing at least 8 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampin and isoniazid. SIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in adult and pediatric patients (2 years and older and weighing at least 8 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampin and isoniazid. Limitations of Use : Do not use SIRTURO for the treatment of latent, extra-pulmonary or drug-sensitive TB or for the treatment of infections caused by non-tuberculous mycobacteria. Limitations of Use Do not use SIRTURO for the treatment of: Latent infection due to Mycobacterium tuberculosis ( M. tuberculosis ) Drug-sensitive pulmonary TB Extra-pulmonary TB Infections caused by non-tuberculous mycobacteria

Dosage and administration (summary)

Administer SIRTURO by directly observed therapy (DOT). Emphasize need for compliance with full course of therapy. Prior to administration, obtain ECG, liver enzymes and electrolytes. Obtain susceptibility information for the background regimen against Mycobacterium tuberculosis isolate if possible. Only use SIRTURO in combination with at least 3 other drugs to which the patient's TB isolate has been shown to be susceptible in vitro. If in vitro testing results are unavailable, may initiate SIRTURO in combination with at least 4 other drugs to which patient's TB isolate is likely to be susceptible.

Contraindications

None. None.

Warnings and precautions

mortality imbalance was seen in clinical trials in SIRTURO-treated patients with pulmonary TB due to Mycobacterium tuberculosis resistant to at least rifampin. Hepatotoxicity may occur with use of SIRTURO. Monitor liver-related laboratory tests. Discontinue SIRTURO if evidence of liver injury occurs. QTc Prolongation SIRTURO prolongs the QTc interval . Use with drugs that prolong the QTc interval may cause additive QTc prolongation .

Pregnancy

Pregnancy Risk Summary Available data from published literature of SIRTURO use in pregnant women are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks associated with active TB during pregnancy (see Clinical Considerations ) .

Storage and supply

Storage and Handling SIRTURO 20 mg Tablet Store in original container. Bottle contains desiccant. Do not discard desiccant. Protect from light and moisture. Keep the container tightly closed. Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) . SIRTURO 100 mg Tablet Dispense in original container.

Source: Bedaquiline Fumarate (Sirturo) — US FDA prescribing information, 2025-10-17, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.