BEDAQUILINE FUMARATE (SIRTURO)
What to know about BEDAQUILINE FUMARATE — also sold as SIRTURO: uses, side effects, interactions, and safety considerations for people taking it or caring for someone who is.
BEDAQUILINE FUMARATE (brand names: SIRTURO) is classified as Moderate risk (3 risk points) by AllMeds. It is a S4 medication under the TGA in Australia. FDA approved in the United States. Anti-tuberculosis drug with significant QTc prolongation and hepatotoxicity risks.
Key Takeaways
- TGA Schedule: S4 in Australia
- Risk level: Moderate (3 points)
- Recommended maximum duration: 168 days
Scheduling and Classification
| Jurisdiction | Classification | Status |
|---|---|---|
| Australia (TGA) | S4 | Not PBS listed |
| United States (FDA) | Rx only | FDA approved |
Risk Profile
Anti-tuberculosis drug with significant QTc prolongation and hepatotoxicity risks.
How BEDAQUILINE FUMARATE is regulated
BEDAQUILINE FUMARATE is overseen by medicines regulators in each country. The rules below explain how it's scheduled, what oversight applies, and what to discuss with your doctor or pharmacist before starting, changing, or stopping this medication.
Australia TGA / PBS / State Schemes
Classified as S4 under the Therapeutic Goods Administration (TGA).
United States FDA / CDC / State WC
FDA approved for use in the United States.
FDA Boxed Warning: WARNING: QTc PROLONGATION QTc prolongation can occur with SIRTURO. Use with drugs that prolong the QTc interval may cause additive QTc prolongation. Monitor ECGs. Discontinue SIRTURO if significant ventricular arrhythmia or QTc interval greater than 500 ms develops [see Warnings and Precautions (5.1) ] . WARNING: QTc PROLONGATION See full prescribing information for complete boxed warning. QTc Prolongation QTc prolongation can occur with SIRTURO. Use with drugs that prolong the QTc interval may cause additive QTc prolongation. Monitor ECGs. Discontinue SIRTURO if significant ventricular arrhythmia or QTc interval greater than 500 ms develops. ( 5.1 )
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Important: This page is general health information, not personal medical advice. If you have questions about your medication — including starting it, stopping it, changing the dose, or combining it with something else — speak with your doctor or pharmacist. For an emergency or suspected overdose, call your local emergency number or poison information service immediately. Information is drawn from regulator and clinical guideline sources (TGA, FDA, MHRA, NICE, PBS, CDC); see our methodology for details.