Bedaquiline
Multidrug-Resistant Tuberculosis
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Drug Status
Government Approvals
US(FDA), UK(BNF)
WHO Essential Medicine
YES
Known Teratogen
No
Pharmaceutical Class
Diarylquinoline Antimycobacterial
Controlled Drug Substance
No
Bedaquiline
Summary
Bedaquiline is used to treat multidrug-resistant tuberculosis (MDRTB) in adults and children aged 5 years and older. It specifically targets pulmonary TB that is resistant to certain other TB medications.
Bedaquiline works by inhibiting an enzyme called mycobacterial ATP synthase, which is crucial for the energy production of the tuberculosis bacteria. By blocking this enzyme, it disrupts the bacteria's energy supply, leading to its death and helping to clear the infection.
For adults, the recommended dosage of Bedaquiline is 400 mg once daily for the first two weeks, followed by 200 mg three times per week for the next 22 weeks. For children aged 5 years and older weighing at least 15 kg, the dosage is based on body weight.
Common side effects of Bedaquiline include nausea, joint pain, headache, coughing up blood, and chest pain. Serious adverse effects include changes in heart rhythm, liver toxicity, and an increased risk of death.
Bedaquiline can cause serious heart rhythm changes and liver toxicity. It should not be used in patients with a history of heart problems or those taking other medications that prolong the heart's QT interval. Liver function should be monitored, and alcohol and other liver-toxic drugs should be avoided during treatment.
Indications and Purpose
How does Bedaquiline work?
Bedaquiline works by inhibiting the mycobacterial ATP synthase, an enzyme crucial for the energy production of Mycobacterium tuberculosis. By blocking this enzyme, Bedaquiline disrupts the bacteria's energy supply, leading to its death and helping to clear the infection.
Is Bedaquiline effective?
Bedaquiline has been shown to be effective in treating multi-drug resistant tuberculosis (MDR-TB) in clinical trials. It works by inhibiting the mycobacterial ATP synthase, an enzyme essential for the energy production of the bacteria. Studies have demonstrated that Bedaquiline, when used in combination with other TB medications, can lead to faster sputum culture conversion and improved treatment outcomes compared to placebo.
What is Bedaquiline?
Bedaquiline is used to treat multi-drug resistant tuberculosis (MDR-TB) in adults and children aged 5 years and older. It works by inhibiting the mycobacterial ATP synthase, an enzyme essential for the bacteria's energy production, effectively killing the bacteria. Bedaquiline is used in combination with other TB medications to improve treatment outcomes.
Directions for Use
For how long do I take Bedaquiline?
Bedaquiline is typically used for a total duration of 24 weeks. In some cases, treatment may be extended beyond 24 weeks if necessary, but this should be determined by a healthcare provider.
How do I dispose of Bedaquiline?
If you can, bring unused medicines to a drug take-back program or collection site at a pharmacy or hospital. They will dispose of this medicine properly so they don't harm people or the environment. If you can't find a take-back program, you can throw most medicines in the trash at home. But first, take them out of their original containers, mix them with something undesirable like used coffee grounds, seal the mixture in a plastic bag and throw it away.
How do I take Bedaquiline?
Bedaquiline should be taken with food to enhance its absorption. It is important to follow the prescribed dosing schedule and not to skip doses. Patients should avoid alcohol and discuss with their doctor about consuming grapefruit or grapefruit juice, as it may interact with the medication.
How long does it take for Bedaquiline to start working?
Bedaquiline begins to work within the first few weeks of treatment, as evidenced by improvements in sputum culture conversion rates. However, the full course of treatment lasts 24 weeks to ensure the infection is effectively treated and to prevent the development of drug resistance.
How should I store Bedaquiline?
Bedaquiline should be stored in its original container, tightly closed, and kept at room temperature away from light, excess heat, and moisture. The container includes a desiccant packet to keep the tablets dry, which should not be discarded. Keep the medication out of reach of children.
What is the usual dose of Bedaquiline?
For adults, the recommended dosage of Bedaquiline is 400 mg once daily for the first two weeks, followed by 200 mg three times per week for the next 22 weeks. For children aged 5 years and older weighing at least 15 kg, the dosage is based on body weight. For those weighing 15 kg to less than 30 kg, it's 200 mg once daily for the first two weeks, then 100 mg three times per week. For those weighing 30 kg or more, the adult dosage applies.
Warnings and Precautions
Can Bedaquiline be taken safely while breastfeeding?
Bedaquiline is excreted in breast milk and may cause serious adverse reactions in a breastfed infant, including hepatotoxicity. Therefore, breastfeeding is not recommended during treatment with Bedaquiline and for 27.5 months after the last dose unless infant formula is not available. If breastfeeding is necessary, monitor the infant for signs of adverse reactions.
Can Bedaquiline be taken safely while pregnant?
There is limited data on the use of Bedaquiline during pregnancy, and its effects on the fetus are not well established. Animal studies have not shown harm to the fetus, but due to the lack of human data, Bedaquiline should be used during pregnancy only if the potential benefits outweigh the risks. Pregnant women should consult their healthcare provider for personalized advice.
Can I take Bedaquiline with other prescription drugs?
Bedaquiline should not be used with strong CYP3A4 inducers like rifampin, as they can reduce its effectiveness. It should also be used cautiously with other QT-prolonging drugs, such as clofazimine and levofloxacin, due to the risk of additive QT prolongation. Patients should inform their healthcare provider of all medications they are taking to avoid potential interactions.
Does Bedaquiline have adverse effects?
Adverse effects are unwanted or harmful effects caused by a medicine. Bedaquiline can cause nausea, joint pain, headache, and chest pain. These are not very common but can occur. A serious adverse effect is an abnormal heart rhythm, which is rare but needs immediate medical attention. If you experience any new or unusual symptoms while taking Bedaquiline, it's important to report them to your healthcare provider. Never stop taking the medicine without consulting your doctor, as they can help manage side effects and adjust treatment if necessary.
Does Bedaquiline have any safety warnings?
Bedaquiline comes with safety warnings, particularly regarding its effect on heart rhythm. It can cause a condition called QT prolongation, which affects the heart's electrical activity and can lead to serious heart problems. Symptoms to watch for include dizziness, fainting, or a fast or irregular heartbeat. If you experience any of these, seek medical attention immediately. It's important to have regular heart monitoring while on Bedaquiline to catch any issues early. Always follow your doctor's advice and report any unusual symptoms.
Is Bedaquiline addictive?
Bedaquiline has no known potential for dependence or addiction. It is not habit-forming, and there are no behaviors or warning signs associated with addiction to this medicine. You can take Bedaquiline as prescribed by your healthcare provider without worrying about developing an addiction. Always follow your doctor's instructions and complete the full course of treatment to ensure the best outcome for your health.
Is Bedaquiline safe for the elderly?
There is limited data on the use of Bedaquiline in patients aged 65 and older. Therefore, it is important for elderly patients to be closely monitored by their healthcare provider while taking this medication. Adjustments to the treatment plan may be necessary based on individual health conditions and response to the medication.
Is it safe to drink alcohol while taking Bedaquiline?
Drinking alcohol while taking Bedaquiline is not recommended as it increases the risk of serious side effects, particularly liver-related issues. Alcohol can exacerbate the hepatotoxic effects of Bedaquiline, making it important to avoid alcohol consumption during treatment.
Is it safe to exercise while taking Bedaquiline?
Most people tolerate Bedaquiline well, and it should not limit your ability to exercise. There is no information suggesting that Bedaquiline affects exercise capacity, physical strength, or endurance. However, if you experience any unusual symptoms like dizziness or fatigue during physical activity, it's important to take precautions and consult your healthcare provider. Always listen to your body and adjust your exercise routine as needed.
Is it safe to stop Bedaquiline?
Bedaquiline is used for treating a temporary or acute condition, specifically certain types of tuberculosis. Stopping Bedaquiline abruptly can lead to the infection not being fully treated, which may cause the bacteria to become resistant to the medicine. This can make the infection harder to treat in the future. There are no known withdrawal symptoms, but it's crucial to complete the full course as prescribed. Always consult your doctor before stopping Bedaquiline to ensure it's safe and appropriate for your situation.
What are the most common side effects of Bedaquiline?
A side effect is an unwanted reaction to a medicine. Common side effects of Bedaquiline include nausea, joint pain, headache, chest pain, and dizziness. These are not very common but can occur. It's important to note that new symptoms might not always be related to the medicine and could be temporary or due to another condition. Always talk to your healthcare provider before stopping any medicine, as they can help determine the cause of symptoms and adjust treatment if necessary.
Who should avoid taking Bedaquiline?
Bedaquiline can cause serious heart rhythm changes, including QT prolongation, which can lead to life-threatening arrhythmias. It should not be used in patients with a history of heart problems, such as congenital long QT syndrome, or those taking other medications that prolong the QT interval. Liver function should be monitored, as Bedaquiline can cause hepatotoxicity. Alcohol and other hepatotoxic drugs should be avoided during treatment.
