Bedaquiline

Bedaquiline is used along with at least three other medications to treat adults with multi-drug resistant tuberculosis (MDR-TB; a serious infection that affects the lungs and other parts of the body and that cannot be treated with at least two of the medications that are usually used to treat the condition) that has affected the lungs. Bedaquiline should not be used to treat TB that mainly affects other parts of the body. Bedaquiline is in a class of medications called anti-mycobacterials. It works by killing the bacteria that cause MDR-TB.

Bedaquiline comes as a tablet to take by mouth. It is usually taken with food once a day for 2 weeks and then three times a week for 22 weeks. When you are taking bedaquiline three times a week, allow at least 48 hours between doses. Take bedaquiline at the same time of day and on the same days of the week every week. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take bedaquiline exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole with plenty of water.

Continue to take bedaquiline until you finish the prescription and do not miss doses, even if you feel better. If you stop taking bedaquiline too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics. This will make your infection harder to treat in the future. To make it easier for you to take all of your medication as directed, you may participate in a directly observed therapy program. In this program, a healthcare worker will give you each dose of medication and will watch as you swallow the medication.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

You should not use bedaquiline if you are allergic to it.

To make sure bedaquiline is safe for you, tell your doctor if you have:

• heart disease or a heart rhythm disorder;

• a personal or family history of long QT syndrome;

• a history of heart failure, or slow heartbeats caused by underactive thyroid;

• human immunodeficiency virus (HIV);

• liver or kidney disease;

• an electrolyte imbalance (such as low levels of calcium, potassium, or magnesium in your blood); or

• if you have ever had an abnormal electrocardiogram or ECG (sometimes called an EKG).

This medicine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether bedaquiline passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Bedaquiline is not approved for use by anyone younger than 18 years old.

Follow all directions on your prescription label. Use only the prescribed dose of this medication, and do not use it for longer than your doctor recommends. Follow all patient instructions for safe use.

Take with food.

Take this medicine with a full glass of water. Swallow the tablet whole. Do not break.

Bedaquiline is usually taken every day for 2 weeks, and then only 3 times per week for the next 22 weeks.

Follow your doctor's dosing instructions very carefully.

Bedaquiline must be given in combination with other tuberculosis medications and it should not be used alone. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics.

While using bedaquiline, you may need frequent blood tests. Your heart function may also need to be checked with an electrocardiograph or ECG (sometimes called an EKG).

Store this medicine in the original container at room temperature away from moisture and heat.

Avoid drinking alcohol. It may increase your risk of liver damage while you are taking 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:

• headache and severe dizziness, fainting, fast or pounding heartbeats;

• chest pain;

• coughing up blood; or

• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• nausea, loss of appetite;

• headache;

• skin rash; or

• joint pain.

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.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Chest pain or pressure.
• Very bad dizziness.
• Coughing up blood.

Commonly reported side effects of bedaquiline include: headache and nausea. Other side effects include: hepatic insufficiency, increased liver enzymes, increased serum alanine aminotransferase, increased serum aspartate aminotransferase, increased serum transaminases, and anorexia. See below for a comprehensive list of adverse effects.

End-stage renal disease requiring hemodialysis or peritoneal dialysis: Use with caution.