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Overview: Sirturo is used with other medicines for tuberculosis. Common side effects include nausea, vomiting, joint pain, and headache. It is important to complete your prescribed course of Sirturo, even if your symptoms get better or go away. This will reduce the risk that future infections are resistant to Sirturo or other similar medicines.

Uses

What is Sirturo used for?

Sirturo (bedaquiline) is commonly used to treat tuberculosis (in combination with other medicine).

Sirturo may not be appropriate for some of the infections listed above, depending on which germs are causing the infection. Bacteria in some locations may have developed resistance to bedaquiline, which will make it not work as well.

Sirturo may also be used for other conditions as determined by your health care provider.

How does Sirturo work (mechanism of action)?

Sirturo helps stop the tuberculosis bacteria from multiplying in your body. This makes it easier for your body to fight off the infection and get rid of the bacteria.

How is Sirturo supplied (dosage forms)?

Brands and other names

  • Sirturo

Dosage forms and strengths

  • 20 mg oral tablets
  • 100 mg oral tablets

How should I store Sirturo?

Sirturo 20 mg should be stored in the original container at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place, protected from light. If the bottle has a desiccant in it, do not throw it away. This is to help protect the tablets from moisture.

Side Effects

What are the most common side effects of Sirturo?

The most common side effects of Sirturo are listed below. Side effects may vary based on the age of the person being treated. Tell your health care provider if you have any of these side effects that bother you.

  • Nausea and vomiting
  • Joint pain
  • Headache
  • Chest pain
  • Coughing up blood
  • Stomach pain
  • Dizziness
  • Itching, dry skin, and rash
  • Trouble sleeping
  • Heart rhythm changes (see below)
  • Feeling of skipped heartbeats
  • Changes in liver function tests

There may be other side effects of Sirturo that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Sirturo?

While less common, the most serious side effects of Sirturo are described below, along with what to do if they happen.

Heart Rhythm Changes. Sirturo may cause a rare, dangerous heart rhythm problem called QT prolongation and torsade de pointes. Some people have a higher risk of this, including people who are older, have other people in their family who have had these conditions, have low potassium or magnesium levels, or who take medicines that can prolong the QT interval. Tell your health care provider right away if you faint or have changes in your heart rate or rhythm, such as a fast or skipping heartbeat.

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Sirturo. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Severe Allergic Reactions. Sirturo may cause allergic reactions, which can be serious. Stop taking Sirturo and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Warnings & Precautions

Warnings & Precautions

Who should not use Sirturo?

Allergies to Ingredients. People who are allergic to any of the following should not take Sirturo.

  • Bedaquiline
  • Sirturo
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Sirturo.

What should I know about Sirturo before using it?

Do not take Sirturo unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Sirturo with other people, even if they have the same condition as you. It may harm them.

Keep Sirturo out of the reach of children.

Your health care provider will likely check your heart rhythm and order blood tests before prescribing this medicine and while you are taking it to monitor the health of your heart and liver and monitor for electrolyte imbalances. It is important to keep all appointments, including those for blood work. 

It is important to complete your prescribed course of Sirturo, even if your symptoms get better or go away. This will reduce the risk that future infections are resistant to Sirturo or other similar medicines.

What should I tell my health care provider before using Sirturo?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Sirturo is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • History of taking medicine to treat tuberculosis
  • Irregular heart rate or rhythm 
  • Electrolyte imbalance
  • Thyroid problems
  • Heart disease, including heart failure
  • Liver problems
  • Kidney problems
  • HIV or AIDS

Other Medicines and Supplements. Sirturo may interact with other medicines and supplements. Before taking Sirturo, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how Sirturo could affect pregnancy or harm an unborn baby. Tell your health care provider if you are or plan to become pregnant.

Breastfeeding. Sirturo passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will advise you if you should take Sirturo while breastfeeding. If you breastfeed while taking Sirturo, monitor your baby for side effects, including yellowing of the whites of your baby’s eyes, dark urine (pee), or light colored poop. Tell your health care provider right away if you notice any of these things.

How can I get more information about Sirturo?

For more information about Sirturo, you can visit the manufacturer’s website at www.janssenscience.com/products/sirturo or call them at 800-526-7736.

Interactions

Does Sirturo interact with foods or drinks?

Sirturo should be taken with food. Food helps your body absorb the medicine so it can work well.

It is unknown if drinking alcohol will affect Sirturo. The risk of liver damage may be increased if you drink alcohol while taking Sirturo. It is best to avoid drinking alcohol while taking Sirturo.

Does Sirturo interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before using Sirturo.

  • Any other medicine used to treat tuberculosis, including rifampin (Rifadin) or rifapentine (Priftin)
  • Efavirenz, which is a medicine for HIV or AIDS
  • Ketoconazole, which is a medicine used for fungal infections
  • Medicines within the past two weeks that can cause QT prolongation, which is a potentially dangerous heart rhythm problem

Many other medicines may alter the blood levels of Sirturo. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Sirturo. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Sirturo?

If you or someone else has used too much Sirturo, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Sirturo?

If you miss a dose during the first two weeks of taking Sirturo, skip the missed dose and only take the next dose. If you miss a dose from week three and on, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.

It is important to complete your prescribed course of Sirturo, even if your symptoms get better or go away. This will reduce the risk that future infections are resistant to Sirturo or other similar medicines.