Sirturo

Pronunciation: ser-toor-oh
Generic name: bedaquiline
Dosage form: oral tablet
Drug class: Diarylquinolines

Medically reviewed by Carmen Pope, BPharm. Last updated on Jun 25, 2024.

What is Sirturo?

Sirturo (bedaquiline) is an oral antimycobacterial treatment that may be used as a part of combination therapy in adults and children (5 years of age and older and weighing at least 33 pounds) with tuberculosis (TB) of the lungs that is resistant to at least rifampin and isoniazid tablets.

Sirturo is a diarylquinoline antibiotic that works by disrupting the ability of mycobacteria to produce ATP, their primary energy source. It does this by blocking the production of the enzyme ATP (adenosine 5-triphosphate) synthase in mycobacteria, which is essential for ATP production by the bacterium. Without energy, bacteria die.

Sirturo gained full FDA approval on 21 June 2024. It was initially first approved under the accelerated approval designation on December 31, 2012.

Sirturo side effects

The most common side effects of Sirturo in adults include:

heart rhythm problem (QTc prolongation)
nausea
vomiting
joint pain
rash
increased liver enzymes
stomach pain
itching
dizziness
headache
chest pain
trouble sleeping
dry skin
heart pounding
coughing up blood.

The most common side effects of Sirturo in children:

12 years to less than 18 years of age include joint pain, nausea, and stomach pain.
5 years to less than 12 years of age is increased level of liver enzymes in the blood.

These are not all the possible side effects of Sirturo. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA1088.

Serious side effects and warnings

Sirturo can cause serious side effects, including:

A serious heart rhythm problem called QTc prolongation. This condition can cause an abnormal heartbeat in people who take it. Your healthcare provider should check your heart and do blood tests before and during treatment with Sirturo. Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat) or if you feel dizzy or faint.

Liver problems (hepatotoxicity). Your healthcare provider should do blood tests to check your liver before you start taking Sirturo and during treatment. Call your healthcare provider right away if you have unexplained symptoms such as:

nausea or vomiting
stomach pain
fever
weakness
itching
unusual tiredness
loss of appetite
light-colored bowel movements
dark colored urine
yellowing of your skin or the white of your eyes.

It is not known if Sirturo is safe and effective in:

people who have tuberculosis (TB) infection, but do not show symptoms of TB (also known as latent TB)
people who have TB of the lungs that is not resistant to antibiotics
people who have types of TB other than TB of the lungs
people who have an infection caused by bacteria other than TB.
children under 5 years of age or weighing less than 33 pounds (15 kg).

Before taking

Before you take Sirturo, tell your healthcare provider about all your medical conditions including, if you:

take any medicines for your heart.
have had an abnormal heart rhythm (ECG) or other heart problems.
have a family history of a heart problem called “congenital long QTc syndrome” or heart failure
have decreased thyroid gland function (hypothyroidism).
have liver or kidney problems.
have HIV infection.
are pregnant or plan to become pregnant
are breastfeeding or plan to breastfeed.

Pregnancy

It is not known if Sirturo will harm your unborn baby.

Breastfeeding

Do not breastfeed while taking Sirturo, and for 27.5 months (2 years 3 months, and 2 weeks) after your last dose, unless formula is not available.

Sirturo passes into breast milk. Talk to your healthcare provider about the best way to feed your baby while taking Sirturo.

If you have to breastfeed because formula is not available, tell your healthcare provider right away if your baby has:

yellowing of their eyes
lighter than usual stool color or stool that is pale or light brown
darker than usual urine color.

How should I take Sirturo?

Take Sirturo exactly as your healthcare provider tells you to take it. The dosage of Sirturo is based on weight.

15kg to 30 kg (33 to 66 pounds): 200mg once daily for 2 weeks then 100 mg three times per week for 22 weeks (total treatment time 24 weeks).
Greater than or equal to 30 kg (66 pounds): 400mg once daily for 2 weeks then 200 mg three times per week for 22 weeks (total treatment time 24 weeks).

You will take Sirturo for a total of 24 weeks.

Always take Sirturo tablets with food.

Swallow them whole with water or split the tablets in half at the score line in the middle of the tablet into 2 equal parts, then swallow both half parts with water.

Sirturo must always be taken with other medicines to treat TB. Your healthcare provider will decide which other medicines you should take with it. You may need to take your other TB medicines for longer than 24 weeks.

Complete the full course of treatment with Sirturo and do not skip doses.

Skipping doses may decrease the effectiveness of the treatment and increase the chances that your TB will not be treatable by Sirturo or other medicines.
Week 1 and Week 2: Take your prescribed dose 1 time each day.
Week 3 to Week 24: Take your prescribed dose 3 times a week. Take Sirturo doses at least 48 hours apart. For example, you may take Sirturo on Monday, Wednesday, and Friday every week from week 3 to week 24.

What happens if I cannot swallow Sirturo tablets?

If you or the person you are caring for cannot swallow Sirturo tablets then you can mix the tablets with water or crush them and take them with soft food.

Mixing Sirturo with water

Use 1 teaspoon (5 mL) of water for a maximum of 5 Sirturo tablets. Mix well in a drinking cup.

Swallow the mixture immediately, or add at least 1 more teaspoon (5 mL) of beverage or soft food and mix.
Beverages such as water, milk products, apple juice, orange juice, cranberry juice, or carbonated beverages may be used. Soft foods such as yogurt, apple sauce, mashed banana, or porridge may be used. Swallow the mixture immediately.
Make sure no remaining medicine is left in the drinking cup, rinse with a beverage or soft food, and swallow the mixture immediately.

If you need more than 5 tablets of Sirturo to get your total dose, repeat the steps above until you reach your prescribed dose.

Crushing Sirturo tablets

Crush tablets and mix them with soft food. Soft food such as yogurt, apple sauce, mashed bananas, or porridge may be used. Swallow the mixture immediately.

Make sure no remaining medicine is left in the container, add more soft food, and swallow the mixture immediately.

Sirturo 20 mg tablets may also be given through certain feeding tubes by your healthcare provider.

Sirturo 100mg tablets should be swallowed whole with water and taken with food.

What should I avoid while taking Sirturo?

Avoid alcohol, hepatotoxic medications, or herbal products.

What happens if I miss a dose?

Do not skip Sirturo doses. If you skip doses or do not complete the total 24 weeks of treatment it may not work as well, and your TB may be harder to treat.

If you miss your Sirturo dose during Week 1 or Week 2:

Do not take a double dose to make up for the missed dose. Take the next dose as usual.

If you miss your Sirturo dose during Week 3 to Week 24:

Take the missed dose as soon as possible and continue taking Sirturo on the 3 times a week schedule.
Make sure that there are at least 24 hours between taking the missed dose and the next scheduled dose.

Do not take more than the prescribed weekly dose in 7 days.

If you miss a dose and you are not sure what to do, talk to your healthcare provider.

Do not stop taking Sirturo without first talking to your healthcare provider.

What happens if I overdose?

If you take more Sirturo than you should, talk to a healthcare provider right away.

What other drugs will affect Sirturo?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

You should not take certain liver medicines or herbal supplements while taking Sirturo. Avoid the use of strong and moderate CYP3A4 inducers such as rifampin and efavirenz.

Your healthcare provider will closely monitor your safety (such as liver function) if you take Sirturo with CYP3A4 inhibitors (such as clarithromycin, erythromycin, or diltiazem).

Storage

Store Sirturo at room temperature between 68°F to 77°F (20°C to 25°C). Keep in its original container to protect it from light.

The Sirturo 20 mg container contains a desiccant packet to keep your medicine dry (protect it from moisture). Do not throw away (discard) the desiccant or eat it.

Keep out of reach of children.

Sirturo ingredients

Active ingredient: bedaquiline fumarate

Sirturo 20 mg tablets, inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose 2910 5 mPa.s, polysorbate 20, purified water (removed during processing), silicified microcrystalline cellulose, and sodium stearyl fumarate.

Sirturo 100 mg tablets, inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose 2910 15 mPa.s, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 20, purified water (removed during processing)