Pronunciation: bed AK wi leen

Brand: Sirturo

What is the most important information I should know about bedaquiline?

Bedaquiline can cause serious and sometimes fatal side effects. This medicine should be used only if you have no other treatment options. Use only the prescribed dose of this medication, and follow all patient instructions for safe use.

Bedaquiline can cause a serious side effect on your heart. Tell your doctor if you have fast or irregular heartbeats and sudden dizziness, like you might pass out.

What is bedaquiline?

Bedaquiline is an antibiotic that is used together with other medications to treat tuberculosis of the lungs that has been resistant to other antibacterial medications.

Bedaquiline is for use in adults and children at least 5 years old and weighing at least 33 pounds (15 kilograms).

Bedaquiline can cause serious and sometimes fatal side effects. This medicine should be used only if you have no other treatment options.

Bedaquiline may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking bedaquiline?

Tell your doctor if you have ever had:

  • heart problems or a heart rhythm disorder;
  • underactive thyroid;
  • long QT syndrome (in you or a family member);
  • human immunodeficiency virus (HIV);
  • liver or kidney disease; or
  • an electrolyte imbalance (such as low blood levels of calcium, potassium, or magnesium in your blood).

Follow your doctor's instructions about using this medicine if you are pregnant. Having tuberculosis during pregnancy could harm both mother and baby.

If you are breastfeeding, tell your doctor if you notice decreased appetite, sleepiness, nausea, stomach pain or swelling, dark urine, clay-colored-stools, or yellowing of the skin or eyes in the nursing baby.

How should I take bedaquiline?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may receive this medicine in a doctor's office or other clinic setting.

Bedaquiline is usually taken every day for 2 weeks, and then only 3 times per week (at least 48 hours between doses) for the next 22 weeks. Follow your doctor's dosing instructions very carefully. You may need to take fewer tablets for each dose after the first 2 weeks of treatment.

Always take bedaquiline with food.

Take the 100-milligram (mg) tablet with water. Swallow the tablet whole and do not crush, chew, or break it.

The 20-mg tablet may be broken along the split line if needed.

If you cannot swallow a 20-mg tablet whole, you may dissolve the tablet in water, and then mix it with a beverage or soft food. Read and carefully follow all instructions about mixing the 20-mg tablet to make it easier to swallow. Ask your doctor or pharmacist if you do not understand these instructions.

Doses are based on weight in children and teenagers. Your child's dose may change if the child gains or loses weight.

Keep using this medicine even if your symptoms quickly improve. Skipping doses could make your infection resistant to medication.

Bedaquiline should not be used without other tuberculosis medication. Use all medications as directed. Do not change your dose or stop using a medicine without your doctor's advice.

You may need medical tests to check your heart function.

Store this medicine in the original container at room temperature away from moisture, heat, and light. Do not use bedaquiline after the expiration date on the label has passed.

What happens if I miss a dose?

If you miss a dose during the first 2 weeks of treatment: Skip the missed dose and use your next dose at the regular time.

If you miss a dose during week 3 or later: Take the dose as soon as you can and keep taking the medicine on the 3 times per week schedule.

Do not use two doses at one time.

Call your doctor for instructions if you are not sure what to do if you miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking bedaquiline?

Drinking alcohol may increase your risk of liver damage.

Avoid taking an herbal supplement.

What are the possible side effects of bedaquiline?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
  • chest pain;
  • coughing up blood or vomit that looks like coffee grounds; or
  • liver problems --loss of appetite, stomach pain (upper right side), tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • coughing up blood;
  • chest pain;
  • nausea, stomach pain;
  • headache;
  • joint pain; or
  • abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect bedaquiline?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Bedaquiline can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Many drugs can affect bedaquiline. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.

Where can I get more information?

Your doctor or pharmacist can provide more information about bedaquiline.

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