Bedaquiline Fumarate (1 brand name, 1 dosage form, 1 route)
Available dosage forms: TABLET.
Routes of administration: ORAL.
Brand Names
- SIRTURO
Boxed Warning
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)] .
Indications and Usage
SIRTURO 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.
Contraindications
None.
Adverse Reactions
The following serious adverse reactions are discussed elsewhere in the labeling: QTc Prolongation [see Warnings and Precautions (5.1)and Clinical Pharmacology (12.2)] Mortality Imbalance in Clinical Trials [see Warnings and Precautions (5.2)] Hepatotoxicity [see Warnings and Precautions (5.4)] Drug Interactions [see Warnings and Precautions (5.5)]
Mechanism of Action
Bedaquiline is a diarylquinoline antimycobacterial drug [see Microbiology (12.4)] .
Overdosage
There is no experience with the treatment of acute overdose with SIRTURO. Take general measures to support basic vital functions including monitoring of vital signs and ECG (QTc interval) in case of deliberate or accidental overdose. It is advisable to contact a poison control center to obtain the latest recommendations for the management of an overdose. Since bedaquiline is highly protein-bound, dialysis is not likely to significantly remove bedaquiline from plasma.