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Generic Name: bedaquiline (bed AK wi leen)
Brand Names: Sirturo

What is Sirturo?

Sirturo (bedaquiline) is an antibiotic that fights bacteria.

Sirturo is used together with other medications to treat tuberculosis that has been resistant to other antibacterial medications.

Sirturo can cause serious and sometimes fatal side effects. This medicine should be used only if you have no other treatment options.

Important information

Sirturo can cause serious and sometimes fatal side effects. This medicine should be used only if you have no other treatment options. Use only the prescribed dose of this medication, and follow all patient instructions for safe use.

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Sirturo can affect your heart rhythm, especially if you also take certain other medicines. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with this medicine.

Before taking this medicine

You should not use Sirturo if you are allergic to bedaquiline.

To make sure Sirturo is safe for you, tell your doctor if you have:

  • heart disease or a heart rhythm disorder;

  • a personal or family history of long QT syndrome;

  • a history of heart failure, or slow heartbeats caused by underactive thyroid;

  • human immunodeficiency virus (HIV);

  • liver or kidney disease;

  • an electrolyte imbalance (such as low levels of calcium, potassium, or magnesium in your blood); or

  • if you have ever had an abnormal electrocardiogram or ECG (sometimes called an EKG).

Sirturo is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether bedaquiline passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Sirturo is not approved for use by anyone younger than 18 years old.

How should I take Sirturo?

Take Sirturo exactly as prescribed by your doctor. Follow all directions on your prescription label. Use only the prescribed dose of this medication, and do not use it for longer than your doctor recommends. Follow all patient instructions for safe use.

Take Sirturo with food.

Take this medicine with a full glass of water. Swallow the tablet whole. Do not break.

Sirturo is usually taken every day for 2 weeks, and then only 3 times per week for the next 22 weeks.

Follow your doctor's dosing instructions very carefully.

Sirturo must be given in combination with other tuberculosis medications and it should not be used alone. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

Use bedaquiline for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics.

While using Sirturo, you may need frequent blood tests. Your heart function may also need to be checked with an electrocardiograph or ECG (sometimes called an EKG).

Store this medicine in the original container at room temperature away from moisture and heat.

Sirturo dosing information

Usual Adult Dose of Sirturo for Tuberculosis -- Resistant:

-Week 1 and Week 2: 400 mg orally once a day.
-Week 3 to Week 24: 200 mg orally 3 times per week, with at least 48 hours between doses.
-Duration of therapy: 24 weeks

-Required testing prior to treatment: Susceptibility information for the background regimen against Mycobacterium tuberculosis isolate if possible; ECG; serum potassium, calcium, and magnesium concentrations; and liver enzymes.
-Use this drug only in combination with 3 other antimycobacterial drugs to which the patient's multi-drug resistant tuberculosis (MDR-TB) isolate has been shown to be susceptible in vitro. If in vitro testing results are unavailable, treatment may be initiated in combination with at least 4 other drugs to which the patient's MDR-TB isolate is likely to be susceptible.
-Administer by directly observed therapy (DOT).
-This drug should be reserved for use when an effective treatment regimen cannot otherwise be provided.

Use: Part of combination therapy in the treatment of adults 18 years and older with pulmonary multi-drug resistant tuberculosis (MDR-TB).

What happens if I miss a dose?

If you miss a dose during the first 2 weeks of treatment: Skip the missed dose and do not take extra medicine to make up the missed dose.

If you miss a dose during week 3 or later: Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Sirturo?

Avoid drinking alcohol. It may increase your risk of liver damage while you are taking Sirturo.

Sirturo side effects

Get emergency medical help if you have signs of an allergic reaction to Sirturo: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • headache and severe dizziness, fainting, fast or pounding heartbeats;

  • chest pain;

  • coughing up blood; or

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Sirturo side effects may include:

  • nausea, loss of appetite;

  • headache;

  • skin rash; or

  • joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Sirturo?

Sirturo can cause a serious heart problem, especially if you use certain medicines at the same time, including other antibiotics, antidepressants, heart rhythm medicine, antipsychotic medicines, and medicines to treat cancer, malaria, HIV or AIDS.

Many drugs can interact with bedaquiline, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Sirturo. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about Sirturo.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Sirturo only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2015 Cerner Multum, Inc. Version: 2.01. Revision Date: 2015-10-06, 2:29:12 PM.