When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to bedaquiline.

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than 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. Wait 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. Ask your pharmacist or doctor if you are not sure about what dose to take. It is important that you keep taking this medicine for the full 24 weeks.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose, weeks 1 and 2: Skip the missed dose and take your next dose at the regular time. Do not take extra medicine to make up for the missed dose.
• Missed dose, weeks 3 to 24: Take the missed dose as soon as you can. Then go back to your regular schedule. Do not take extra medicine to make up for the missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the medicine in its original container.

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

• Some medicines can affect how bedaquiline works. Tell your doctor if you are taking any of the following:
  
  • An antibiotic, such as azithromycin, ciprofloxacin, clarithromycin, erythromycin
  • Clofazimine
  • HIV/AIDS medicine, such as efavirenz, lamivudine, lopinavir, ritonavir, tenofovir
  • Ketoconazole
  • Other medicine to treat tuberculosis, such as rifabutin, rifampin, rifapentine
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney or liver disease, HIV, or a low calcium, magnesium, or potassium level. Tell your doctor if you have a history of underactive thyroid, or if you or anyone in your family has a history of a heart problem (such as slow heartbeat, QT prolongation, heart attack, or heart failure).
• This medicine may cause the following problems:
  
  • A serious liver problem
  • Heart rhythm changes
• 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.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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 urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, 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

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