Brand name: BEDAQUIS
Composition:
Each tablet contains:
Bedaquiline fumarate……………………….…….100mg
Indications:
BEDAQUIS is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in adults (≥ 18 years) with pulmonary multi-drug-resistant tuberculosis (MDR-TB). Reserve BEDAQUIS for use when an effective treatment regimen cannot otherwise be provided. BEDAQUIS is not indicated for the treatment of latent, extra-pulmonary or drug-sensitive tuberculosis.
Dosage: 400mg once daily for 2 weeks followed by 200 mg 3 times per week for 22 weeks with food. Swallow BEDAQUIS tablets whole with water.
Contraindications: None.
Warnings:
• QT prolongation can occur with BEDAQUIS. Monitor ECGs frequently.
• Discontinue BEDAQUIS if significant ventricular arrhythmia or a QTcF interval > 500 ms develops.
• Use with drugs that prolong the QT interval may cause additive QT prolongation. Monitor ECGs more frequently.
• Hepatic-related adverse drug reactions have been reported with use of BEDAQUIS. Monitor liver-related laboratory tests.
• Non-adherence to the treatment regimen could result in failure or resistance.
Adverse Effects:
• The most common adverse reactions reported in ≥10% of patients treated with BEDAQUIS are nausea, arthralgia, and headache.
• Additional adverse events reported in ≥10% of patients treated with BEDAQUIS and with a higher frequency than the placebo treatment group are hemoptysis and chest pain.
Dosage form: Is supplied as uncoated white to almost white round biconvex 100 mg tablets
Expiry date: 24 months from the date of manufacture.
Packaging: 188 tablets per bottle.
Storage:
• Store at 25°C; excursions permitted to 15-30°C.
• Keep out of reach of children.
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