Bedaquiline (bed-AK-wi-leen)

Treats tuberculosis (TB).

Brand Name(s):

Sirturo

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed. This medicine must always be taken with at least 3 other medicines for TB. Carefully follow your doctor's instructions.
• 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.
• 100-mg tablet: Swallow the tablet whole with water. Do not crush, break, or chew it.
• If you can swallow the 20-mg tablet whole:
  • Swallow the tablet whole with water.
  • You may also split it in half at the score line (middle of the tablet) and swallow each half-tablets (10 mg) with water.
• If you cannot swallow the 20-mg tablet whole:
  • Mix a maximum of 5 tablets into 1 teaspoon (5 milliliters) of water in a drinking cup.
    • Swallow the mixture right away.
    • To help with taking the mixture, you may add at least 1 more teaspoon (5 mL) of beverage (including water, milk products, carbonated beverage, or apple, orange, or cranberry juice) or soft food (including yogurt, applesauce, mashed banana, or porridge) and mix, then swallow it right away.
    • Make sure no medicine is left in the drinking cup, rinse with beverage or soft food and swallow it right away.
    • If you need more than 5 tablets to get your total dose, repeat these steps until you reach the desired dose.
  • Crush the tablets and mix with soft food (including yogurt, applesauce, mashed banana, or porridge), then swallow the mixture right away. Make sure no medicine is left in the container, add more soft food and swallow it right away.
• The 20-mg tabletmay also be given through a feeding tube by your doctor or nurse.
• 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:
  • Clarithromycin, clofazimine, itraconazole, ketoconazole
  • Medicine that may cause heart rhythm problems
  • Medicine to treat HIV/AIDS (including efavirenz, lopinavir/ritonavir)
  • Medicine to treat an infection (including fluoroquinolone or macrolide antibiotics)
  • Other medicine to treat tuberculosis (including 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 if you have kidney disease, liver disease, HIV infection, any type of infection (including other types of TB), or a history of heart failure, heart rhythm problems (including slow heartbeat, QT prolongation), or underactive thyroid.
• Do not breastfeed during treatment and for 27.5 months (2 years 3 months and 2 weeks) after the last dose.
• This medicine may cause the following problems:
  • Heart rhythm changes, including QT prolongation
  • Liver problem
• 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