Proper Use

Drug information provided by: IBM Micromedex

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Bedaquiline is given by directly observed therapy (DOT). It must always be taken with at least 3 other medicines for TB. Carefully follow your doctor's instructions.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

It is best to take this medicine with food.

Swallow the 100-mg tablet whole with water. Do not crush, break, or chew it. Take this medicine with food.

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 each) 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 (eg, water, milk products, carbonated beverage, or apple, orange, or cranberry juice) or soft food (eg, 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 (eg, 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 tablet may also be given through a nasogastric tube by your doctor or nurse.

This medicine is taken for a total of 24 weeks. On the first 2 weeks, you will take the medicine every day. On the 3rd to 24th week, you have to take it at the same time on the same 3 days (eg, Monday, Wednesday, and Friday) at least 48 hours apart each week.

Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For treatment of multi-drug resistant tuberculosis:
      • Adults and children 5 years of age and older weighing at least 30 kilograms (kg)—
        • Week 1-2: 400 milligrams (mg) (4 tablets of 100 mg or 20 tablets of 20 mg) once a day.
        • Week 3-24: 200 mg (2 tablets of 100 mg or 10 tablets of 20 mg) 3 times per week (with at least 48 hours between doses), for a total of 600 mg per week.
      • Children 5 years of age and older weighing 15 to less than 30 kg—
        • Week 1-2: 200 mg (2 tablets of 100 mg or 10 tablets of 20 mg) once a day.
        • Week 3-24: 100 mg (1 tablet of 100 mg or 5 tablets of 20 mg) 3 times per week (with at least 48 hours between doses), for a total of 300 mg per week.
      • Children younger than 5 years of age or weighing less than 15 kg—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you missed a dose during the first 2 weeks, skip the missed dose and continue to use your medicine as usual. If you missed a dose during weeks 3 to 24, take the missed dose as soon as possible and then go back to your normal dosing schedule.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the medicine in its original container.