Bedaquiline Oral tablet
What is this medicine?
BEDAQUILINE is used to treat tuberculosis (TB) infections of the lungs.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
history of irregular heartbeat
history of low levels of calcium, magnesium, or potassium in the blood
HIV or AIDS
if you often drink alcohol
an unusual or allergic reaction to bedaquiline, other medicines, foods, dyes or preservatives
pregnant or trying to get pregnant
How should I use this medicine?
Take this medicine by mouth with a glass of water. Take this medicine with food. Do not cut, crush or chew this medicine. It will be given to you by a health care professional. Take your medicine at regular intervals. Do not take your medicine more often than directed. Take all of your medicine as directed even if you think you are better. Do not skip doses or stop your medicine early.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
It is important not to miss your dose. If you miss a dose during the first 2 weeks, do not make up the missed dose. If you miss a dose after the first 2 weeks, take the missed dose as soon as you can.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
certain antibiotics like rifampin, rifapentine, rifabutin
certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole
This medicine may also interact with the following medications:
antiviral medicines for HIV or AIDS, such as efavirenz
certain antibiotics like azithromycin, chloroquine, ciprofloxacin, clarithromycin, erythromycin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin, pentamidine
certain medicines for irregular heart beat like amiodarone, disopyramide, ibutilide, procainamide, propafenone, quinidine, sotalol
certain medicines for nausea like chlorpromazine, droperidol
certain medicines for psychotic disturbances like haloperidol
other medicines that prolong the QT interval (cause an abnormal heart rhythm)
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.
Visit your doctor or health care professional for regular check ups. You may need blood work done while you are taking this medicine.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
fast, irregular heartbeat
feeling faint or lightheaded, falls
general ill feeling or flu-like symptoms
loss of appetite, nausea
right upper belly pain
unusually weak or tired
yellowing of the eyes or skin
Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):
chest pain or chest tightness
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep this medicine in the original container. Throw away any unused medicine after the expiration date.
NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
March 21, 2017
U.S. FDA-approved Package Insert