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SIRTURO
Bedaquiline
$47120.00
100mg · 188 tablets · 15 months supply
BrandBranded medicine· By Janssen
$3220.05 per month
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Annual cost
$47120a year at this pack size
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FDA boxed warningQtc 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
QTc Prolongation
About SIRTURO
Overview
SIRTURO contains bedaquiline, an antimycobacterial medicine. It is used with other medicines to treat tuberculosis (TB) in the lungs that is resistant to at least rifampin and isoniazid, in adults and children aged 2 years and older who weigh at least 8 kg. It works against the bacteria that cause TB. It must not be used for latent TB, TB outside the lungs, drug-sensitive TB or infections caused by non-tuberculous mycobacteria.
What it treats
Pulmonary tuberculosis (TB) resistant to at least rifampin and isoniazid, as part of combination therapy in adults and children aged 2 years and older who weigh at least 8 kg.
Safety information
Side effects
Common side effects reported in adults include nausea, vomiting, joint pain, headache, abdominal pain, dizziness, chest pain, coughing up blood, itching, rash, dry skin, difficulty sleeping, palpitations and increased liver enzymes. Prolongation of the QTc interval, a change in the heart’s electrical activity, was also commonly reported in one adult study. In children, commonly reported side effects varied by age: joint pain, nausea and abdominal pain in those aged 12 to under 18 years; increased liver enzymes in those aged 5 to under 12 years; and vomiting in those aged 2 to under 5 years. Serious risks include QTc prolongation and liver injury. Contact a doctor promptly about palpitations, chest pain or coughing up blood. Liver injury may be detected through blood tests; the label calls for monitoring liver-related tests and stopping SIRTURO if evidence of liver injury occurs. A difference in deaths between treatment groups was also observed in clinical trials involving SIRTURO-treated patients with pulmonary tuberculosis resistant to at least rifampin.
FDA 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
QTc Prolongation
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
The supplied FDA label lists no contraindications to Sirturo. Caution is needed in people with severe liver impairment; it should be used only when the benefits outweigh the risks, with monitoring for adverse reactions. Caution is also needed in people with severe kidney impairment. Sirturo can cause liver injury. Liver blood tests should be monitored, and treatment should be stopped if there is evidence of liver injury. Clinical trials found an imbalance in deaths among Sirturo-treated patients with pulmonary tuberculosis resistant to at least rifampin. Breastfeeding is not recommended unless infant formula is unavailable. If a baby is exposed through breast milk, the baby should be monitored for adverse reactions, including liver injury. Safety and effectiveness have not been established in children younger than 2 years or weighing less than 8 kg.
Interactions
Avoid taking SIRTURO with medicines that strongly or moderately increase the activity of the enzyme CYP3A4, as they can affect how SIRTURO is processed in the body. Ask your doctor to check whether any of your medicines fall into this group. Medicines that block CYP3A4 require close safety monitoring when taken with SIRTURO, including checks of liver function.
Using SIRTURO
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store below 25°C in a dry place, in the original pack, away from direct light and moisture. Do not keep it in a bathroom. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP] (DailyMed, retrieved 19 September 2026).
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