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Sirturo

Generic Name: Bedaquiline (bed AK wi leen)
Brand Name: Sirturo

  • More deaths were seen in people taking Sirturo (bedaquiline) compared to people not taking it. The cause of this is not known. This medicine is only for use when other drugs cannot be used.
  • A type of abnormal heartbeat (prolonged QT interval) can happen with this medicine. Call your doctor right away if you have a fast heartbeat, a heartbeat that does not feel normal, or if you pass out.
  • Your doctor will watch your heartbeat with a test called an ECG.
  • Before taking Sirturo, tell your doctor if you are taking any drugs that can raise the chance of a heartbeat that is not normal. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.

Uses of Sirturo:

  • It is used to treat TB (tuberculosis).

What do I need to tell my doctor BEFORE I take Sirturo?

  • If you have an allergy to bedaquiline or any other part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are taking any of these drugs: Efavirenz, rifabutin, rifampin, or rifapentine.
  • If you are taking any drugs that can raise the chance of liver problems. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
  • If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with Sirturo.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Sirturo?

  • Tell all of your health care providers that you take Sirturo. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • You will need an ECG before starting this medicine and during treatment. Talk with your doctor.
  • Avoid drinking alcohol while taking Sirturo.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.

How is this medicine (Sirturo) best taken?

Use Sirturo as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Be sure you know how to take this medicine. Talk with your doctor if you have questions.
  • Take with food.
  • Swallow whole with a drink of water.
  • To gain the most benefit, do not miss doses.
  • Keep taking Sirturo as you have been told by your doctor or other health care provider, even if you feel well.
  • This medicine is taken with other drugs. Be sure you know about the warnings, benefits, and risks of these other drugs. Talk with the doctor if you have questions or concerns about any of the drugs.

What do I do if I miss a dose?

Weeks 1 and 2:

  • Skip the missed dose and go back to your normal time.

Week 3 or more:

  • Take a missed dose as soon as you think about it and go back to your normal time.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.

All weeks:

  • Do not take 2 doses at the same time or extra doses.
  • If you are not sure what to do if you miss a dose, call your doctor.

See also: Dosage Information (in more detail)

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Chest pain or pressure.
  • Very bad dizziness.
  • Coughing up blood.

What are some other side effects of Sirturo?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Joint pain.
  • Upset stomach.
  • Not hungry.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

See also: Side effects (in more detail)

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Sirturo?

  • Store in the original container at room temperature.
  • Protect from light.
  • If stored outside of the original container, throw away any part not used after 3 months.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about Sirturo (bedaquiline), please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Sirturo. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Sirturo.

Review Date: October 4, 2017

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