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bedaquiline

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 is used together with other medications to treat tuberculosis of the lungs that has been resistant to other antibacterial medications.

Bedaquiline is for use in adults and children at least 12 years old and weighing at least 66 pounds (30 kilograms).

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?

Tell your doctor if you have ever had:

  • heart problems or a heart rhythm disorder;
  • underactive thyroid;
  • long QT syndrome (in you or a family member);
  • human immunodeficiency virus (HIV);
  • liver or kidney disease;
  • an electrolyte imbalance (such as low levels of calcium, potassium, or magnesium in your blood); or
  • an abnormal electrocardiogram or ECG (sometimes called an EKG).

Follow your doctor's instructions about using this medicine if you are pregnant. Having tuberculosis during pregnancy could harm both mother and baby.

If you are breastfeeding, tell your doctor if you notice decreased appetite, sleepiness, nausea, stomach pain or swelling, dark urine, clay-colored-stools, or yellowing of the skin or eyes in the nursing baby.

How should I take bedaquiline?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take with food and a full glass of water.

Bedaquiline is usually taken every day for 2 weeks, and then only 3 times per week (at least 48 hours between doses) for the next 22 weeks. Follow your doctor's dosing instructions very carefully. You may need to take fewer tablets for each dose after the first 2 weeks of treatment.

You may receive this medicine in a doctor's office or other clinic setting.

Swallow the tablet whole and do not crush, chew, or break it.

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 medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication.

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, heat, and light. Do not use bedaquiline after the expiration date on the label has passed.

What happens if I miss a dose?

If you miss a dose during the first 2 weeks of treatment: Skip the missed dose and use your next dose at the regular time.

If you miss a dose during week 3 or later: Take the dose as soon as you can and keep taking the medicine on the 3 times per week schedule.

Do not use two doses at one time.

Call your doctor for instructions if you are not sure what to do if you miss a 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.

Avoid taking an herbal supplement.

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:

  • fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
  • chest pain;
  • coughing up blood or vomit that looks like coffee grounds; or
  • liver problems --loss of appetite, stomach pain (upper right side), tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • nausea, stomach pain, coughing up blood;
  • 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?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Bedaquiline can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, or malaria.

Many drugs can affect bedaquiline. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your doctor or 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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. 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 absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. 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 1996-2019 Cerner Multum, Inc. Version: 3.01. Revision date: 9/3/2019.

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