Sirturo (bedaquiline) is reserved for treating tuberculosis (TB) that is resistant to other antibiotics. It was FDA-approved under an accelerated process, since there are few options available to treat life-threatening resistant TB lung infection. The medication is also linked to a higher risk of death and heart problems.
Tuberculosis (TB) lung infection that is resistant (doesn't respond to) to other anti-TB antibiotics
Sirturo (bedaquiline) is an antitubercular agent. It kills bacteria by blocking a protein that the bacteria need to make energy and survive.
Source:Â FDA
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
coughing or spitting up blood
dark-colored urine
decreased appetite
general feeling of tiredness or weakness
headache
itching or skin rash
light-colored stools
loss of appetite
stomach pain or tenderness
swelling of the feet or lower legs
unusual tiredness or weakness
yellow eyes or skin
Incidence not known
Dizziness or fainting
fast or irregular heartbeat
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Treats multi-drug resistant tuberculosis (MDR-TB), which is a serious health problem with few new antibiotic options
Can be given to children as young as 5 years old
After the first 2 weeks of taking it daily, you only need to take it 3 times a week.
The 20 mg tablet can be dissolved or crushed for people who can't swallow a whole tablet.
Can be given through feeding tube
Each dose requires multiple tablets and should be taken in front of a healthcare provider.
Must be taken in combination with at least 3 other anti-TB antibiotics
Linked with a higher risk of death, so it should only be used if absolutely needed
Not for TB that is latent (non-active) or TB that has spread outside the lungs
Very expensive, and not available as a generic
Sirturo (bedaquiline) will be prescribed with least three other anti-TB medications to prevent resistance. Make sure you know which medications are part of your anti-TB regimen so you can start them all at the same time. Sometimes, expensive medications like Sirturo (bedaquiline) require extra paperwork before your insurance company will pay for them.
Take Sirturo (bedaquiline) with food for best absorption.
The 100 mg tablet should be swallowed whole with water. If you or your child can't swallow tablets, you can dissolve the 20 mg tablet in water, and then mix it with a beverage or soft food. You can also crush the tablet and mix it into soft food. Drink or eat the mixture right after mixing it; don't prepare it beforehand. Talk to your provider about how to properly prepare the medication to your preference. Doing it incorrectly can cause you to not get the full dose.
To protect your liver, avoid alcohol and herbal supplements while you are taking Sirturo (bedaquiline).
It's best to keep the tablets in the original bottle from the pharmacy manufacturer. This will protect the medication from moisture and light. If the pharmacy does not dispense the medication to you in the original bottle, pay attention to the expiration date on the label. The expiration date should be within 3 months of the date you received the medication. Talk to the pharmacist if this is not the case.
It's very important not to miss any doses of Sirturo (bedaquiline) or other anti-TB medications. Skipping doses can allow the bacteria to grow and become resistant to the antibiotics. To ensure good adherence, a healthcare professional might observe you when you take Sirturo (bedaquiline). These observations can be done in person or virtually depending on available resources.
If you have to go to the hospital for any reason, make sure you bring your Sirturo (bedaquiline) with you so that your treatment is not interrupted. It's an expensive medication that the hospital might not have in their pharmacy. Hospitals have procedures in place for special situations where patients need to continue to take their home medications.
Sirturo (bedaquiline) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
During clinical trials, one study found that more people in the group taking Sirturo (bedaquiline) died compared to number of deaths in the group not given Sirturo (bedaquiline). Though it's unclear why this happened, this medication should only be used when there are no other options to treat your TB infection. Sirturo (bedaquiline) should also not be given to children younger than 5 years old.
Risk factors: Taking other medications that cause heart rhythm problems | History of abnormal EKG or heart rhythm problems | Low thyroid function | Heart failure | Low levels of calcium, magnesium, or potassium in the blood
Sirturo (bedaquiline) can affect the way your heart beats and cause a condition called QT prolongation, which can be serious and potentially life-threatening. Your provider will regularly check your heartbeat and electrolytes to monitor your risk for this side effect. It's important to tell your provider and pharmacist about all of your medications and your past medical history. Certain medications and conditions can put you at a higher risk for QT prolongation and heart rhythm problems. Seek medical help right away if you experience an abnormally fast heart rate or fainting.
TB bacteria can become resistant to antibiotics very easily, which is why most people are prescribed multiple anti-TB medications at the same time. It's very important to take all of your anti-TB medications exactly as prescribed.
Risk factors: History of liver damage
Sirturo (bedaquiline) can cause damage to your liver. This is more likely to happen if you have a history of liver problems, but can happen to anyone, including young children. Your provider will order regular blood tests to monitor the health of your liver. To be safe, avoid alcohol while you are taking Sirturo (bedaquiline), and make sure to check with your provider and pharmacist before taking other medications or supplements in case they also raise your risk of liver injury. Let your provider know right away if you experience fatigue, loss of appetite, nausea or vomiting, dark urine, right-side abdominal pain, or yellowing of the eyes or skin as these can be signs of liver problems.
Certain medications, including rifamycin antibiotics like rifampin (Rifadin), can cause the levels of Sirturo (bedaquiline) in your body to be too low and can lead to antibiotic resistance. Other medications can cause your Sirturo (bedaquiline) levels to be too high and raise your risk of having side effects. Make sure to tell your provider and pharmacist everything that you take, including supplements and over-the-counter medications. Before starting any new medications, make sure your provider knows you're taking Sirturo (bedaquiline).
Adults and children 5 years and older, weighing 30 kg (66 lbs) or more: Take 400 mg by mouth once daily for 2 weeks, then 200 mg three times per week (with at least 48 hours between doses) for 22 weeks.
For the 400 mg dose: Take 4 of the 100 mg tablets, or 20 of the 20 mg tablets.
For the 200 mg dose: Take 2 of the 100 mg tablets, or 10 of the 20 mg tablets.
Children (5 years and older, weighing 15 kg to 30 kg): Take 200 mg by mouth once daily for 2 weeks, then 100 mg three times per week (with at least 48 hours between doses) for 22 weeks.
For the 200 mg dose: Take 2 of the 100 mg tablets, or 10 of the 20 mg tablets.
For the 100 mg dose: Take one 100 mg tablet, or 5 of the 20 mg tablets.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Tuberculosis (TB) lung infection that is resistant (doesn't respond to) to other anti-TB antibiotics
Tuberculosis (TB) that's hard to treat with first-choice antibiotics
Urinary tract infections (UTIs), after first-choice options haven't worked
Tuberculosis (TB) that is resistant (doesn't respond to) to first-choice anti-TB antibiotics (e.g., isoniazid or rifampin (Rifadin))
TB infection in people who can't take other anti-TB antibiotics
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