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Brand Name :
Sirturo
Synonyms :
bedaquiline
Class :
Antitubercular Agents
Brand Name :
Sirturo
Synonyms :
bedaquiline
Class :
Antitubercular Agents
Dosage Forms & Strengths Â
Tablet Â
20mg  Â
100mg Â
Indicated for pulmonary multidrug resistant tuberculosis (MDR-TB) :
Weeks 1-2: 400 mg orally daily
Weeks 3-24: 200 mg orally 3 times a week, with at least 2 days between doses
the maximum duration of therapy is 24 weeks
Dosage Forms & Strengths Â
Tablet Â
20mg  Â
100mg Â
 Â
Indicated for pulmonary multidrug resistant tuberculosis (MDR-TB) :
Age: ≥ 5 years
Weeks 1-2 (Weight ≥ 30 kg): 400 mg orally daily for 2 weeks
Weeks 3-24 (Weight ≥ 30 kg): 200 mg 3 times a week with at least 2 days between each dose
Weeks 1-2 (Weight 15-<30 kg): 200 mg orally daily 2 weeks
Weeks 3-24 (Weight 15-<30 kg): 100 mg 3 times a week with at least 2 days between each dose
Refer to adult dosingÂ
may have an increased QTc-prolonging effect when combined with bedaquiline
may have an increased QTc-prolonging effect when combined with bedaquiline
may have an increased QTc-prolonging effect when combined with bedaquiline
may have an increased QTc-prolonging effect when combined with bedaquiline
may have an increased QTc-prolonging effect when combined with bedaquiline
may enhance the serum concentration of CYP3A4 inhibitors
respiratory syncytial virus vaccine, adjuvanted
May decrease the diagnostic effect when combined with tuberculin Tests
respiratory syncytial virus (RSV) vaccine
May decrease the diagnostic effect when combined with tuberculin Tests
poliovirus vaccine, live, trivalent
May decrease the diagnostic effect when combined with tuberculin Tests
poliovirus vaccine inactivated
May decrease the diagnostic effect when combined with tuberculin Tests
respiratory syncytial virus vaccine, adjuvanted
May decrease the diagnostic effect when combined with tuberculin Tests
respiratory syncytial virus (RSV) vaccine
May decrease the diagnostic effect when combined with tuberculin Tests
May decrease the diagnostic effect when combined with tuberculin Tests
may diminish serum concentrations of CYP3A4 inducers
may diminish serum concentrations of CYP3A4 inducers
may diminish serum concentrations of CYP3A4 inducers
may diminish serum concentrations of CYP3A4 inducers
may diminish serum concentrations of CYP3A4 inducers
it may enhance the qtc interval when combined with lofexidine
nafcillin will decrease the effect of action of bedaquiline by affecting enzyme CYP3A4 metabolism.
the effect of bedaquiline is decreased by lorlatinib, by altering intestinal or hepatic CYP3A4 enzyme metabolism
when both drugs are combined, there may be an increased effect of bedaquiline by affecting hepatic or intestinal enzyme cyp3a4 metabolism  
when both drugs are combined, there may be an increased risk or severity of QTC prolongation  
when both drugs are combined, there may be an increased QTC interval  
CYP3A strong enhancers of the small intestine may reduce the bioavailability of bedaquiline
when used together, entrectinib and bedaquiline both increase the QTc interval
when used together, encorafenib and bedaquiline both increase the QTc interval
may increase the QTc interval when combined
It may enhance QTc interval when combined with pentamidine
it may enhance the risk of QTc prolongation when combined with amifampridine
may enhance the concentration of serums when combined with bedaquiline
may enhance the concentration of serums when combined with bedaquiline
may enhance the concentration of serums when combined with bedaquiline
may enhance the concentration of serums when combined with bedaquiline
may enhance the concentration of serums when combined with bedaquiline
bedaquiline: they may enhance serum concentrations of CYP3A Inhibitors
bedaquiline: they may enhance serum concentrations of CYP3A Inhibitors
bedaquiline: they may enhance serum concentrations of CYP3A Inhibitors
bedaquiline: they may enhance serum concentrations of CYP3A Inhibitors
bedaquiline: they may enhance serum concentrations of CYP3A Inhibitors
When bedaquiline is used together with fluconazole, this leads to reduction in the bedaquiline metabolism
When bedaquiline is used together with capsaicin, this leads to enhanced risk or seriousness of methemoglobinemia
When ponesimod is used together with bedaquiline, this leads to enhanced risk or seriousness of bradycardia
When bedaquiline is used together with adenosine this leads to enhanced risk or seriousness of QTc prolongation
When bedaquiline is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
bedaquiline: it may increase the risk or severity of CNS depression
bedaquiline: it may increase the risk or severity of CNS depression
bedaquiline: it may increase the risk or severity of CNS depression
bedaquiline: it may increase the risk or severity of CNS depression
bedaquiline: it may increase the risk or severity of CNS depression
bedaquiline: it may increase the risk of methemoglobinemia agents
bedaquiline: it may increase the risk of methemoglobinemia agents
bedaquiline: it may increase the risk of methemoglobinemia agents
bedaquiline: it may increase the risk of methemoglobinemia agents
bedaquiline: it may increase the risk of methemoglobinemia agents
when combined with danoprevir, the metabolism of bedaquiline can be reduced
bedaquiline: it may decrease the metabolism of barnidipine
QTc interval is decreased both by lenvatinib and bedaquilin
when both drugs are combined, both increase the QTC interval   
when both drugs are combined, there may be an increased QTC interval  
osimertinib and bedaquiline, when used simultaneously, increase the QTc interval
may decrease the serum concentration of CYP3A4 Inducers
the rate of metabolism of bedaquiline may be reduced
the risk of methemoglobinemia may be increased
Actions and Spectrum:
It is a member of the class of medications known as diarylquinolines. It works by inhibiting the activity of an enzyme called ATP synthase, which is necessary for the bacteria that cause TB to produce energy. This leads to the death of the bacteria and helps to clear the infection.Â
Bedaquiline is active against several species of Mycobacterium, including Mycobacterium tuberculosis, the bacterium that causes TB. It is typically used in combination with other medications as part of a regimen for the treatment of multidrug-resistant TB (MDR-TB). MDR-TB is a form of TB that is resistant to at least two of the most commonly used TB medications (isoniazid and rifampin).Â
It is important to note that bedaquiline should only be used in an appropriate combination regimen to reduce the risk of developing resistance to the medication. The development of resistance to bedaquiline and other TB medications is a major concern in the treatment of TB, as it can make the disease more difficult to treat.Â
Frequency Defined Â
>10% Â
Adults Â
Headache (28%) Â
Nausea (38%) Â
Chest pain (11%) Â
Arthralgia (33%) Â
Pediatrics Â
Nausea (13%) Â
Arthralgia (40%) Â
Abdominal pain (13%) Â
1-10% Â
Adults Â
Rash (8%) Â
Anorexia (9%) Â
Black Box Warnings:
The increased risk of death seen in the bedaquiline treatment group in the clinical trial suggests that bedaquiline may carry a higher risk of serious adverse events compared to placebo.Â
QT prolongation is a condition in which the heart’s electrical activity is prolonged, which can lead to a potentially life-threatening arrhythmia called torsades de pointes. Bedaquiline has been associated with QT prolongation, and coadministration with other drugs that also prolong the QT interval may increase the risk of QT prolongation.
Therefore, it is important to carefully consider the potential risks and benefits of using bedaquiline, particularly in patients with certain medical conditions that may increase their risk of QT prolongation.Â
Contraindication/Caution:
There are several contraindications and precautions to be aware of when using bedaquiline.
Pregnancy warnings:    Â
US FDA pregnancy category: Not assigned.Â
Lactation:  Â
Excreted into human milk is unknown Â
Pregnancy Categories:        Â
Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.   Â
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.  Â
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    Â
Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.    Â
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    Â
Category N: There is no data available for the drug under this categoryÂ
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Pharmacology:
bedaquiline is an antimicrobial drug used to treat tuberculosis (TB). bedaquiline has been shown to be effective in treating multidrug-resistant TB, which is a form of TB that is resistant to traditional TB medications. It is typically used in combination with other TB medications to improve treatment outcomes.Â
Pharmacodynamics:Â
The pharmacodynamics of bedaquiline can be described as follows:Â
Pharmacokinetics:Â
The pharmacokinetics of bedaquiline involves how the drug is absorbed, distributed, metabolized, and eliminated from the body.Â
Absorption: Bedaquiline is well absorbed when taken orally, with peak plasma concentrations occurring within 1-2 hours of ingestion. It has a bioavailability of approximately 80%.Â
Distribution: Bedaquiline is highly protein-bound >99.9% in the bloodstream, primarily to albumin. It has a volume of distribution of approximately 12 L/kg.Â
Metabolism: Bedaquiline is metabolized in the liver by the cytochrome P450 (CYP) 3A4 enzyme. It has several active metabolites, including O-desmethylbedaquiline (M2) and N-desethylbedaquiline (M3).Â
Elimination: Bedaquiline has a half-life of approximately 12-15 days and is eliminated primarily through the feces (60%) and urine (30%). It is not dialyzable.Â
Administration:
bedaquiline administered by directly observed therapy (DOT). DOT means that a healthcare provider or a designated observer is present to watch the patient take their medication and ensure that it is taken as directed.Â
The instructions specify that the medication should be taken with food, and 100 mg tablets should be swallowed whole. For the 20 mg tablets, patients who can swallow them whole or divide them in half with food. For patients who cannot swallow the tablets whole, two methods are provided for preparing and administering the medication:Â
Method 1: Disperse the tablets in a small amount of water, mix well until the tablets are completely dispersed, and then either consume the mixture as is or mix it with a beverage or soft food. Repeat this process as needed until the desired dose is reached, and then consume food immediately afterwards.Â
Method 2: Crush the tablets and mix them with soft food, and then consume the mixture immediately.Â
It is important to follow these instructions carefully to ensure that the medication is taken correctly and to maximize its effectiveness. If you have any questions or concerns about taking your medication, you should speak with your healthcare provider.Â
Patient information leafletÂ
Generic Name: bedaquilineÂ
Why do we use bedaquiline?Â
bedaquiline is a Antitubercular Agents and is used to treat tuberculosis (TB). It is typically used in combination with other TB medications as part of a treatment regimen for TB that is resistant to other drugs.Â
bedaquiline is a member of a class of drugs called diarylquinolines, which work by inhibiting the growth and replication of TB bacteria. It is usually given as an oral tablet that is taken once a day.Â
bedaquiline is usually reserved for use in patients with TB that is resistant to other medications, as it can have serious side effects. Common side effects of bedaquiline include nausea, vomiting, abdominal pain, and dizziness. More serious side effects, such as liver damage and QT prolongation (a type of heart rhythm disturbance), can also occur.Â
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