This medication may increase the risk of death. It should only be used when other treatments have not worked.
Bedaquiline may cause a condition that affects the heart rhythm (QT prolongation). The risk of QT prolongation may be increased if you are taking other drugs that may cause QT prolongation. (See also Precautions section).
This medication must be used with other medications to treat active multi-drug-resistant tuberculosis (TB) of the lungs in people with limited treatment options. Bedaquiline belongs to a class of drugs known as antibiotics. It works by stopping the growth of the bacteria that causes TB.
This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.
Read the Medication Guide provided by your pharmacist before you start taking bedaquiline and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with food, as directed by your doctor, usually once daily for the first 2 weeks, followed by 3 times a week for 22 weeks.
The manufacturer directs not to split/crush the tablet before taking it. However, many similar drugs (immediate-release tablets) can be split/crushed. Follow your doctor's direction on how to take this medication.
Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. If you are taking this medication daily, take it at the same time each day. If you are taking this medication on a weekly schedule, take it on the same days of the week and at the same time of day. Mark the days on the calendar when you need to take the medication.
Continue to take this medication (and other TB medications) until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early or skipping doses may allow bacteria to continue to grow, which may result in a return of the infection.
Tell your doctor if your condition persists or worsens
See also Warning section.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: symptoms of liver damage (such as dark urine, persistent nausea/vomiting/loss of appetite, stomach/abdominal pain, yellowing eyes/skin).
Bedaquiline can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, tell your doctor immediately if you develop any rash.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking bedaquiline, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease.
Bedaquiline may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using bedaquiline, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).
Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using bedaquiline safely.
Alcohol may increase the risk of liver disease. Avoid alcoholic beverages while using this medication.
Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Do not share this medication with others.
This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor directs you to do so. A different medication may be necessary in that case.
Laboratory and/or medical tests (such as liver function, EKG, potassium/calcium/magnesium levels) should be performed before you start treatment and periodically to monitor your progress or check for side effects. Consult your doctor for more details.
If you miss a dose during the first 2 weeks of treatment, skip the missed dose and resume your usual dosing schedule. If you miss a dose from week 3 onward, take it as soon as you remember and resume your 3-times-a-week dosing schedule.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised December 2013. Copyright(c) 2013 First Databank, Inc.
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