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Bedaquiline

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

Bedaquiline may cause serious and sometimes fatal irregular heartbeat (eg, QT prolongation). Tell your doctor right away if you have a fast or irregular heartbeat or if you faint. An increased risk of death has also been reported in patients taking bedaquiline. Talk with your doctor about the risks and benefits of using bedaquiline.


Bedaquiline is used for:

Treating tuberculosis (TB) of the lungs when other treatment has not been effective. Bedaquiline should be used in combination with other medicines.

Bedaquiline is an antibiotic. It works by killing sensitive TB bacteria.

Do NOT use bedaquiline if:

  • you are allergic to any ingredient in bedaquiline
  • you have a certain type of irregular heartbeat (QT prolongation, long QT syndrome)
  • you have low blood potassium, calcium, or magnesium levels
  • you are taking arsenic, asenapine, carbamazepine, citalopram, clozapine, dronedarone, enzalutamide, halofantrine, a hydantoin (eg, phenytoin), nilotinib, ondansetron, phenobarbital, primidone, quetiapine, quinine, a rifamycin (eg, rifampin), saquinavir, St. John's wort, toremifene, trazodone, or vandetanib
  • you are taking medicines that may harm the liver (eg, acetaminophen, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection). Ask your doctor if you are unsure if any of your medicines might harm the liver

Contact your doctor or health care provider right away if any of these apply to you.

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Before using bedaquiline:

Some medical conditions may interact with bedaquiline. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have liver or kidney problems or HIV infection, or if you are on dialysis
  • if you have a history of heart problems (eg, congestive heart failure, slow or irregular heartbeat), thyroid problems, or electrolyte problems (eg, low calcium, potassium, or magnesium levels)
  • if a member of your family has a history of congenital long QT syndrome
  • if you have had a recent heart attack
  • if you are taking any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

Some MEDICINES MAY INTERACT with bedaquiline. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many prescription or nonprescription medicines (eg, used for abortion, anxiety, cancer, Cushing syndrome, depression or other mental or mood problems, hepatitis C infection, HIV, infection, irregular heartbeat or other heart problems, malaria, nausea and vomiting, seizures, trouble sleeping), multivitamin products, or herbal or dietary supplements (eg, St. John's wort) because they may interact with bedaquiline. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with bedaquiline

This may not be a complete list of all interactions that may occur. Ask your health care provider if bedaquiline may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use bedaquiline:

Use bedaquiline as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Bedaquiline comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get bedaquiline refilled.
  • Take bedaquiline by mouth with food.
  • Swallow bedaquiline whole with water. Do not break, crush, or chew before swallowing.
  • To clear up your infection completely, use bedaquiline for the full course of treatment. Keep using it even if you feel better in a few days.
  • Continue to take bedaquiline even if you feel well. Do not miss any doses.
  • If you miss a dose of bedaquiline during week 1 or week 2, skip the missed dose and go back to your regular dosing schedule. If you miss a dose of bedaquiline during week 3 to week 24, take the missed dose as soon as possible and go back to your regular schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use bedaquiline.

Important safety information:

  • Bedaquiline only works against TB bacteria; it does not treat viral infections (eg, the common cold).
  • Do NOT take more than the recommended dose, change your dose, or stop taking bedaquiline without checking with your doctor.
  • Do not drink alcohol while you are using bedaquiline.
  • Be sure to take bedaquiline for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
  • Tell your doctor or dentist that you take bedaquiline before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including electrocardiogram (ECG), blood electrolyte levels, and liver function, may be performed while you use bedaquiline. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Bedaquiline should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using bedaquiline while you are pregnant. It is not known if bedaquiline is found in breast milk. Do not breast-feed while taking bedaquiline.

Possible side effects of bedaquiline:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Headache; joint pain; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; coughing up blood; fainting; fast or irregular heartbeat; symptoms of liver problems (eg, dark urine; pale stools; severe or persistent nausea, vomiting, loss of appetite, or stomach pain; unusual tiredness; yellowing of the skin or eyes).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of bedaquiline:

Store bedaquiline at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in the original container away from heat, moisture, and light. Do not store in the bathroom. Keep bedaquiline out of the reach of children and away from pets.

General information:

  • If you have any questions about bedaquiline, please talk with your doctor, pharmacist, or other health care provider.
  • Bedaquiline is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take bedaquiline or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. 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 bedaquiline. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to bedaquiline. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using bedaquiline.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. 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 this medicine. 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 your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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