bedaquiline

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Pronunciation: bed AK wi leen

Brand: Sirturo

What is the most important information I should know about bedaquiline?

Bedaquiline 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.

Bedaquiline 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 bedaquiline.

What is bedaquiline?

Bedaquiline is an antibiotic that fights bacteria.

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

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

Bedaquiline may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking bedaquiline?

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

To make sure bedaquiline 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).

This medicine 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.

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

How should I take bedaquiline?

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 with food.

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

Bedaquiline 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.

Bedaquiline 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 this medication 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 bedaquiline, 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.

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 bedaquiline?

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

What are the possible side effects of bedaquiline?

Get emergency medical help if you have signs of an allergic reaction: 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 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.

What other drugs will affect bedaquiline?

Bedaquiline 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 bedaquiline. 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 bedaquiline.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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