Bedaquiline oral tablet

What is this medication?

BEDAQUILINE (bed AK wi leen) 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.

COMMON BRAND NAME(S): Sirturo

What should I tell my care team before I take this medication?

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
• thyroid disease
• an unusual or allergic reaction to bedaquiline, other medicines, foods, dyes or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Take this medicine with food. 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. While this drug may be prescribed for children as young as 5 years for selected conditions, precautions do apply.

Overdosage: If you think you have 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?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medication?

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

• alcohol
• cisapride
• dronedarone
• pimozide
• thioridazine

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, rifampin, rifapentine, rifabutin
• certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole
• certain medicines for irregular heart beat like amiodarone, disopyramide, dofetilide, 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)
• ziprasidone

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 medication?

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 checkups. You may need blood work done while you are taking this medicine.

Talk to your healthcare provider before you breastfeed. If you do breastfeed, tell your healthcare provider right away if your baby has darker urine or lighter stool than normal or if their eyes turn yellow.

What side effects may I notice from receiving this medication?

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
• coughing up blood
• signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast or irregular heartbeat; palpitations; feeling faint or lightheaded, falls; breathing problems
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• headache
• joint pain
• nausea
• stomach pain

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 medication?

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.