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Bedaquiline (By mouth)

Bedaquiline (bed-AK-wi-leen)

Treats tuberculosis (TB). This medicine is used only in combination with other medicines for TB.

Brand Name(s):

Sirturo

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

Do not use this medicine if you have had an allergic reaction to bedaquiline.

How to Use This Medicine:

Tablet

  • Take your medicine as directed.
  • Weeks 1 and 2: Take this medicine every day for the first 2 weeks.
  • Weeks 3 to 24: Take this medicine 3 days a week, at the same time on the same days each week. Allow at least 48 hours between each dose.
  • It is best to take this medicine with food or milk.
  • Swallow the tablet whole with a glass of water. Do not crush, break, or chew it.
  • Take all of the medicine in your prescription to clear up your infection, even if you feel better after the first few doses.
  • This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

If a dose is missed:

  • Weeks 1 and 2: If you miss a dose or forget to take your medicine, skip the missed dose and take your next dose at the regular time. Do no take extra medicine to make up for the missed dose.
  • Weeks 3 to 24: Take the missed as soon as you can, then go back to your regular schedule. Do not take extra medicine to make up for the missed dose.
  • Ask your pharmacist or doctor if you are not sure about what dose to take. It is important that you keep taking this medicine.

How to Store and Dispose of This Medicine:

  • Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the medicine in its original container.
  • Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • Make sure your doctor knows if you are also using ketoconazole (Nizoral®), clofazimine (Lamprene®), medicine to treat HIV/AIDS (such as efavirenz, lamivudine, lopinavir, ritonavir, tenofovir, Atripla®, Emtriva®, Epzicom®, Isentress®, Kaletra®, Norvir®, Truvada®), an antibiotic (such as azithromycin, ciprofloxacin, clarithromycin, erythromycin, Avelox®, Levaquin®, Vigamox®, Zithromax®), or other medicine to treat tuberculosis (such as rifabutin, rifampin, rifapentine, Mycobutin®, Priftin®, Rifadin®, Rimactane®).
  • Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

  • Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, a heart problem (such as slow heartbeat, QT prolongation, or heart failure), HIV infection, a recent heart attack, or a history of underactive thyroid. Tell your doctor if you know that you have low levels of calcium, magnesium, or potassium in your blood.
  • Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation or torsade de pointes.
  • Tell your doctor right away if you have dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, yellow skin or eyes. These could be symptoms of a serious liver problem.
  • Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments. Your doctor may also need to check your heart.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Chest pain
  • Coughing or spitting up blood
  • Dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, yellow skin or eyes
  • Fainting, dizziness, lightheadedness
  • Fast, pounding, or uneven heartbeat

If you notice these less serious side effects, talk with your doctor:

  • Headache
  • Muscle or joint pain
  • Nausea

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088


Last Updated: 4/4/2014
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