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. bedaquiline should be used only if you have no other treatment options.

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

Bedaquiline can cause serious and sometimes fatal side effects. bedaquiline 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.

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 bedaquiline 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.

Usual Adult Dose for Tuberculosis -- Resistant:

Weeks 1 and 2: 400 mg orally once a day
Weeks 3 to 24: 200 mg orally 3 times a week, with at least 48 hours between doses
Duration of therapy: 24 weeks

Comments:
-Alcohol should be avoided during treatment.
-Treatment should be given by directly observed therapy (DOT).
-This drug was approved based on sputum culture conversion time in clinical trials; continued approval may be based upon verification and clinical benefit in confirmatory trials.
-Use of this drug should be limited to infections where effective treatment regimens cannot otherwise be provided.
-Treatment should be used with at least 3 other drugs to which the in-vitro multidrug resistant tuberculosis (MDR-TB) isolate has been shown to be susceptible OR with at least 4 other drugs to which the isolate is likely to be susceptible if in-vitro results are unavailable.

Use: Part of combination therapy in the treatment of pulmonary MDR-TB caused by Mycobacterium tuberculosis

Usual Pediatric Dose for Tuberculosis -- Resistant:

12 years and older:
30 kg and over:
-Weeks 1 and 2: 400 mg orally once a day
-Weeks 3 to 24: 200 mg orally 3 times a week, with at least 48 hours between doses
-Duration of therapy: 24 weeks

Comments:
-Alcohol should be avoided during treatment.
-Treatment should be given by DOT, and should be given in combination with other antimycobacterial agents.
-This drug was approved based on sputum culture conversion time in clinical trials; continued approval may be based upon verification and clinical benefit in confirmatory trials.
-Use of this drug should be limited to infections where effective treatment regimens cannot otherwise be provided.
-Treatment should be used with at least 3 other drugs to which the in-vitro MDR-TB isolate has been shown to be susceptible OR with at least 4 other drugs to which the isolate is likely to be susceptible if in-vitro results are unavailable.

Use: Part of combination therapy in the treatment of pulmonary MDR-TB caused by M tuberculosis

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.

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.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom). Keep the desiccant (drying agent) packet in the bottle of medication to keep the tablets dry.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while you are taking this medication.

Drinking alcohol may increase your risk of liver damage.

Avoid taking an herbal supplement.

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

Bedaquiline may cause serious side effects. 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 of bedaquiline 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.

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.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to bedaquiline.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.