Sirturo
Sirturo (bedaquiline) is reserved for treating tuberculosis (TB) that's resistant to other antibiotics. It's an antitubercular agent that helps kill the bacteria causing TB. Sirturo (bedaquiline) is FDA approved for adults and children over the age of 2 who weigh at least 18 lbs. It's a tablet that you take by mouth. You first take the dose once daily for 2 weeks, and then you take half that dose three times a week for the next 22 weeks. Common side effects include nausea, joint pain, and headache. You must take Sirturo (bedaquiline) with other TB medications.
What is Sirturo (bedaquiline)?
What is Sirturo (bedaquiline) used for?
- Lung infection from tuberculosis (TB) that's resistant to or doesn't respond to other TB medications, including rifampin and isoniazid
How Sirturo (bedaquiline) works
Sirturo (bedaquiline) is an antitubercular agent. It works by blocking a protein that bacteria need to make energy and survive. This kills the bacteria that causes TB.
Drug facts
Side effects of Sirturo (bedaquiline)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Nausea (38%)
- Joint pain (33%)
- Headache (28%)
- Coughing up blood (18%)
- Chest pain (11%)
- Low appetite (9%)
- Higher liver enzyme levels (9%)
- Rash (8%)
Note: Side effects were reported in adults taking Sirturo (bedaquiline) with other TB medications. Side effects might differ in children.
Sirturo (bedaquiline) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Heart rhythm problems: palpitations, chest pain, dizziness, lightheadedness, shortness of breath, fainting
- Liver problems: tiredness, loss of appetite, nausea, liver feeling tender, dark urine, yellowing of the skin or whites of the eyes
The following Sirturo (bedaquiline) side effects have also been reported
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.
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Pros and cons of Sirturo (bedaquiline)
Pros
- Treats multi-drug resistant tuberculosis (MDR-TB), which is a serious health problem with few antibiotic options
- Okay for children as young as 2 years old to take
- Taken once daily for 2 weeks, then 3 times a week for the rest of treatment
- Have many options if you have trouble swallowing tablets whole
- Can be given through a feeding tube, if needed
Cons
- Must have a healthcare professional watch you take the medication each time to make sure you follow your treatment plan
- Must take multiple tablets for each dose and treatment lasts many months
- Must take with at least 3 other TB medications
- Only used if absolutely needed because of serious risks
- Not for latent TB (inactive TB) or TB that's spread outside the lungs
Pharmacist tips for Sirturo (bedaquiline)
- Take Sirturo (bedaquiline) once a day for the first 2 weeks of treatment. After that, take half your starting dose 3 times a week with at least 48 hours between each time. Set up reminders on your calendar to help you remember when to take your TB medication. Ask your prescriber if you're not sure when to take Sirturo (bedaquiline) and how much to take.
- It's important that you take Sirturo (bedaquiline) with at least three other TB medications. Take your TB medications exactly as prescribed. This helps fight TB and prevent it from becoming extremely hard to treat. Ask your prescriber if you're not sure which medications are part of your treatment and how to take them.
- A healthcare professional must watch you take Sirturo (bedaquiline) each time. This helps make sure you're following your treatment plan and that you don't miss doses. This is very important because missing doses can make your infection even harder to treat. Ask your care team if you should take your TB medications in person or over a video call.
- Avoid drinking alcohol while taking Sirturo (bedaquiline). This medication has a risk of liver damage, and alcohol can raise this risk more. Talk to your prescriber if you need help to stop drinking during treatment.
- Keep Sirturo (bedaquiline) in the manufacturer's bottle. This will protect the medication from moisture and light. If the pharmacy puts the 100 mg tablets in a different bottle, they're good for up to 3 months from the day you got them. Ask your pharmacist if you have questions about when the medication expires.
- If you have to go to the hospital for any reason, bring your Sirturo (bedaquiline) with you. This helps make sure your TB treatment doesn't get interrupted. The hospital might not have TB medications in their pharmacy. Follow the hospital's rules about bringing home medications to continue your TB treatment.
How to take Sirturo (bedaquiline):
- Take Sirturo (bedaquiline) with food. Food helps the medication get absorbed into the body.
- For the Sirturo (bedaquiline) 100 mg tablets: Swallow the 100 mg tablet whole with water. If you have trouble swallowing tablets whole, you can use the 20 mg tablets for your dose.
- For the Sirturo (bedaquiline) 20 mg tablets and you can swallow tablets: Swallow the 20 mg tablet whole. You can also split the tablet in half along the score line into two equal halves of 10 mg each. Then, swallow the halves with water.
- For the Sirturo (bedaquiline) 20 mg tablets and you cannot swallow tablets: There are two options. 1) Dissolve up to 5 tablets in a teaspoon of water. If needed, you can add at least 5 mL of a beverage or 1 teaspoonful of soft food to the mixture to help with taste. Swallow the mixture right away and repeat if you need to take more tablets. 2) You can also crush the tablets and mix into soft food. Swallow the medication right after mixing. Ask your prescriber or pharmacist if you're not sure how to prepare the medication.
- If you have a feeding tube, ask your prescriber about how to take Sirturo (bedaquiline). You can give the 20 mg tablets through certain feeding tubes. Your prescriber can give you instructions to do this in a safe way.
What to do if you miss a dose of Sirturo (bedaquiline):
- If you miss a dose during the first 2 weeks: Skip the missed dose. Just wait until the next day to take your usual dose at your usual time. Don't take two doses at once to make up for the missed dose. If you're not sure what to do, ask your care team.
- If you miss a dose after the first 2 weeks: Take the missed dose as soon as you remember. Then, continue with your usual 3 times a week dosing schedule. Make sure there's at least 24 hours between taking the missed dose and your next dose. In any given 7-day period, don't take more than your usual weekly dose. If you're not sure what to do, call your care team for help.
Common questions about Sirturo (bedaquiline)
You can only get Sirturo (bedaquiline) with a prescription from a healthcare professional. They usually specialize in treating TB or infections. With that prescription, you'll get the medication from a specialty pharmacy. This means that Sirturo (bedaquiline) isn't available from your regular pharmacy. You also can't find it over the counter. Your healthcare team will work with you to get Sirturo (bedaquiline) for your TB treatment.
You'll usually take Sirturo (bedaquiline) for 24 weeks, or about 6 months. Don't stop taking Sirturo (bedaquiline) unless your prescriber tells you to. This is important so that the medication can work its best to treat TB. But sometimes, your prescriber might stop treatment early if there are signs of serious side effects. Ask your prescriber if you have questions about how long to take Sirturo (bedaquiline).
Sirturo (bedaquiline) is FDA approved. This means it's considered safe for treating tuberculosis (TB) that's resistant to other antibiotics. But it also has some serious risks. These include heart rhythm problems and liver damage. There's also possibly a higher risk of death, though the reason isn't clear. Because of these serious risks, your prescriber will only choose Sirturo (bedaquiline) when no other options are available to treat your TB. Your prescriber will weigh the risks and benefits for you. Talk to them to learn more about the medication's safety.
In one study, some people had neuropathy or nerve discomfort. This could feel like numbness, tingling, "pins and needles," or pain in the fingers and toes. Keep in mind that you take Sirturo (bedaquiline) with other TB medications. It's possible that your other medications could be contributing to these nerve problems. Tell your prescriber about any new numbness, tingling, pain, or "pins and needles" while taking this medication. They can help figure out the cause and help manage it.
Sirturo (bedaquiline) was first approved by the FDA in 2012 using an accelerated process. It was the first new medication for TB to get approved in over 40 years that worked in a unique way to fight TB. Its approval for resistant TB was very important because the infection can be very hard to get rid of. After more studies showed that it has clinical benefits, Sirturo (bedaquiline) was fully approved by the FDA in 2024.
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Risks and warnings for Sirturo (bedaquiline)
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.
Heart rhythm problems
- Risk factors: Taking other medications that cause heart rhythm problems | History of heart rhythm problems | History of long QT syndrome | Slow heart rate | Worsening heart failure | Hypothyroidism (low thyroid hormone) | Low calcium, magnesium, or potassium
Sirturo (bedaquiline) can cause a heart problem called QT prolongation. It makes the heart take longer to reset after each beat. This can affect your heart rhythm, which can be serious.
Before starting Sirturo (bedaquiline), tell your prescriber about your health conditions and the medications you take. Some conditions, like low electrolytes and thyroid problems, can put you at risk of QT prolongation. Your risk is also higher if you take other medications that can cause this same heart problem. These can include amiodarone (Pacerone), azithromycin, and moxifloxacin (Avelox). Your prescriber can make sure Sirturo (bedaquiline) is safe for you.
Your prescriber will check your heart with an electrocardiogram (EKG). They'll also check your electrolyte levels. They'll check before you start Sirturo (bedaquiline) and during treatment. These tests help monitor your risk of QT prolongation. If problems show up, you might need to stop Sirturo (bedaquiline).
Let your care team know if your heart feels like it's racing or if you faint. These could be signs of heart rhythm problems.
Possible higher risk of death based on adult studies
A few studies found that more adults who took Sirturo (bedaquiline) died than those who didn't. We don't know why this happened.
Because of this risk, Sirturo (bedaquiline) should only be used when there are no other options to treat your TB infection. Your prescriber will help decide based on the risks and benefits to you. Talk to your prescriber if you have questions about this risk.
Liver damage
- Risk factors: History of liver damage | Drinking alcohol | Taking other medications that can harm the liver
In studies, some people, including children 5 and older, who took Sirturo (bedaquiline) had liver damage. The risk is higher if you've had liver problems, drink alcohol, or take medications that harm the liver.
Avoid alcohol while taking Sirturo (bedaquiline). Also tell your prescriber and pharmacist about all your medications and supplements. They can check your risk of liver damage.
Your prescriber will order regular blood tests to check your liver during treatment. Tell your care team right away if you have signs of liver problems. This includes tiredness, loss of appetite, stomach pain on the right side, nausea, vomiting, dark urine, or yellow skin or eyes. You might need to stop Sirturo (bedaquiline) if your liver tests are high or if you have symptoms.
Drug interactions
It's important for your prescribers and pharmacist to check for drug interactions with Sirturo (bedaquiline). Tell them about all the medications you take. This includes prescription medications, over-the-counter products, and herbal supplements. Always let them know about any new medications you plan to take.
Some medications, like rifampin, can make Sirturo (bedaquiline) not work as well to treat TB. This can lead to antibiotic resistance and make TB harder to treat. Others, like clarithromycin, can raise the risk of side effects. If you're taking a medication that interacts with Sirturo (bedaquiline), your care team can help to keep you safe.
Sirturo (bedaquiline) dosage
Tablet| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 100mg | 24 tablets | $3,682.84 | $153.45 |
| 20mg | 60 tablets | $1,844.54 | $30.74 |
Typical dosage for Sirturo (bedaquiline)
-
Adults
- Weeks 1 and 2: Take 400 mg by mouth once a day. To get your full dose, take 4 of the 100 mg tablets, or 20 of the 20 mg tablets.
- Weeks 3 to 24: Take 200 mg by mouth three times per week (with at least 48 hours between doses). To get your full dose, take 2 of the 100 mg tablets, or 10 of the 20 mg tablets.
-
Children 2 years and older, weighing 66 lbs or more
- Weeks 1 and 2: Take 400 mg by mouth once a day. To get the full dose, take 4 of the 100 mg tablets, or 20 of the 20 mg tablets.
- Weeks 3 to 24: Take 200 mg by mouth three times per week (with at least 48 hours between doses). To get the full dose, take 2 of the 100 mg tablets, or 10 of the 20 mg tablets.
-
Children 2 years and older, weighing 33 lbs to less than 66 lbs
- Weeks 1 and 2: Take 200 mg by mouth once a day. To get the full dose, take 2 of the 100 mg tablets, or 10 of the 20 mg tablets.
- Weeks 3 to 24: Take 100 mg by mouth three times per week (with at least 48 hours between doses). To get the full dose, take one 100 mg tablet, or 5 of the 20 mg tablets.
-
Children 2 years and older, weighing 22 lbs to less than 33 lbs
- Weeks 1 and 2: Take 120 mg by mouth once a day. To get the full dose, take 6 of the 20 mg tablets.
- Weeks 3 to 24: Take 60 mg by mouth three times per week (with at least 48 hours between doses). To get the full dose, take 3 of the 20 mg tablets.
-
Children 2 years and older, weighing 18 lbs to less than 33 lbs
- Weeks 1 and 2: Take 80 mg by mouth once a day. To get the full dose, take 4 of the 20 mg tablets.
- Weeks 3 to 24: Take 40 mg by mouth three times per week (with at least 48 hours between doses). To get the full dose, take 2 of the 20 mg tablets.
Interactions between Sirturo (bedaquiline) and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
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.
- Bepridil
- Cisapride
- Dronedarone
- Fluconazole
- Ketoconazole
- Mesoridazine
- Nelfinavir
- Pimozide
- Piperaquine
- Posaconazole
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Ziprasidone
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.
- Abametapir
- Alfuzosin
- Amiodarone
- Amisulpride
- Amprenavir
- Anagrelide
- Apomorphine
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Artemether
- Asenapine
- Atazanavir
- Boceprevir
- Buprenorphine
- Buserelin
- Carbamazepine
- Ceritinib
- Chloroquine
- Citalopram
- Clarithromycin
- Clofazimine
- Clozapine
- Cobicistat
- Conivaptan
- Crizotinib
- Cyclobenzaprine
- Dabrafenib
- Dasatinib
- Degarelix
- Delamanid
- Delavirdine
- Deslorelin
- Deutetrabenazine
- Disopyramide
- Dofetilide
- Domperidone
- Donepezil
- Droperidol
- Efavirenz
- Encorafenib
- Entrectinib
- Enzalutamide
- Erythromycin
- Escitalopram
- Fingolimod
- Flecainide
- Fluoxetine
- Formoterol
- Fosamprenavir
- Foscarnet
- Fosphenytoin
- Fostemsavir
- Gatifloxacin
- Glasdegib
- Gonadorelin
- Goserelin
- Halofantrine
- Haloperidol
- Histrelin
- Hydroxychloroquine
- Hydroxyzine
- Ibutilide
- Idelalisib
- Iloperidone
- Indinavir
- Inotuzumab Ozogamicin
- Itraconazole
- Ivabradine
- Ivosidenib
- Lapatinib
- Lefamulin
- Lenvatinib
- Levofloxacin
- Lofexidine
- Lopinavir
- Lumefantrine
- Macimorelin
- Methadone
- Metronidazole
- Mirtazapine
- Moxifloxacin
- Nafarelin
- Nefazodone
- Nilotinib
- Ofloxacin
- Ondansetron
- Osilodrostat
- Osimertinib
- Oxaliplatin
- Ozanimod
- Paliperidone
- Panobinostat
- Pasireotide
- Pazopanib
- Phenytoin
- Pimavanserin
- Pitolisant
- Ponesimod
- Primidone
- Quetiapine
- Quinidine
- Ranolazine
- Ribociclib
- Rifabutin
- Rifampin
- Rifapentine
- Ritonavir
- Selpercatinib
- Sertraline
- Sevoflurane
- Siponimod
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
- Solifenacin
- Sotalol
- St John's Wort
- Sulpiride
- Sunitinib
- Tacrolimus
- Telaprevir
- Telithromycin
- Tetrabenazine
- Tipranavir
- Trazodone
- Triclabendazole
- Triptorelin
- Vandetanib
- Vemurafenib
- Vinflunine
- Voclosporin
- Voriconazole
- Zuclopenthixol
How much does Sirturo (bedaquiline) cost?
$1,844.54
What are alternatives to Sirturo (bedaquiline)?
Sirturo (bedaquiline) images
