Bedaquiline Oral Tablet

BEDAQUILINE is used to treat tuberculosis (TB) infections of the lungs.

This drug can cause serious side effects. See which side effects you should report to your doctor right away.

Know how to use your medication, and learn what might happen if you miss a dose.

Talk to your healthcare provider if you have any of these conditions.

Know what to watch for and get tips for reducing your risks while taking this drug.

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
• dark urine
• fast, irregular heartbeat
• feeling faint or lightheaded, falls
• general ill feeling or flu-like symptoms
• light-colored stools
• 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
• headache
• joint pain
• rash

Do not take this medicine with any of the following medications:

• alcohol
• certain antibiotics like rifampin, rifapentine, rifabutin
• certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole
• cisapride
• dofetilide
• dronedarone
• pimozide
• thioridazine
• ziprasidone

This medicine may also interact with the following medications:

• antiviral medicines for HIV or AIDS, such as efavirenz
• arsenic trioxide
• 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
• methadone
• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

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.

They need to know if you have any of these conditions:

• heart disease
• history of irregular heartbeat
• history of low levels of calcium, magnesium, or potassium in the blood
• HIV or AIDS
• if you often drink alcohol
• liver disease
• an unusual or allergic reaction to bedaquiline, other medicines, foods, dyes or preservatives
• pregnant or trying to get pregnant
• breast-feeding

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.

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.

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.