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.
From the U.S. FDA-approved label for Bedaquiline. Full label: DailyMed.
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.
From the U.S. FDA-approved label for Bedaquiline. Full label: DailyMed.
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.
Directions from the U.S. FDA-approved label — your doctor or pharmacist may advise differently.
A 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. 5.1 QTc Prolongation SIRTURO prolongs the QTc interval. Use with drugs that prolong the QTc interval may cause additive QTc prolongation.
Warnings and precautions excerpt from the U.S. FDA-approved label — not a complete list. Talk to a pharmacist or doctor before use.
The following serious adverse reactions are discussed elsewhere in the labeling: QTc Prolongation Mortality Imbalance in Clinical Trials Hepatotoxicity Drug Interactions The most common adverse reactions reported in 10% or more adult patients treated with SIRTURO in Study 1 were nausea, arthralgia, headache, hemoptysis and chest pain.
Excerpt from the U.S. FDA-approved label — not a complete list. Talk to a pharmacist or doctor about side effects.
16.2 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.
Storage information from the U.S. FDA-approved label.
This page is information only and is not medical advice. Medicine details come from the sources listed above and may change — always confirm the medicine, strength and dose with a pharmacist or doctor before use. NLEM listing does not guarantee that a medicine is in stock at any pharmacy.
