Bedaquiline

Bedaquiline should only be used to treat people who have 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) when other treatments cannot be used. In a clinical study, there were more deaths among people who took bedaquiline than among people who did not take the medication. However, MDR-TB is a life-threatening disease, so you and your doctor may decide that you should be treated with bedaquiline if other treatments cannot be used.

Bedaquiline may cause serious or life-threatening changes in your heart rhythm. You will need to have an electrocardiogram (ECG; a test that measures the electrical activity of the heart) before your treatment and several times during your treatment to see how this medication affects your heart rhythm. Tell your doctor if you or anyone in your family has prolonged QT syndrome (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death) and if you have or have ever had a slow or irregular heartbeat, an underactive thyroid gland, low levels of calcium, magnesium, or potassium in your blood, heart failure, or a recent heart attack. Tell your doctor and pharmacist if you are taking any of the following medications: azithromycin (Zithromax), ciprofloxacin (Cipro), clarithromycin (Biaxin), clofazimine (Lamprene), erythromycin (E.E.S, E-Mycin, Erythrocin), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), and telithromycin (Ketek). If you develop a fast or irregular heartbeat or if you faint, call your doctor immediately.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with bedaquiline and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.

Talk to your doctor about the risks of taking bedaquiline.

🔔 Why is this medication prescribed?

Bedaquiline is used along with at least three other medications to treat 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 other medications that are usually used to treat the condition) in adults and children 5 years and older who weigh at least 33 lbs (15 kg) 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.

🔔 How should this medicine be used?

Bedaquiline comes as a tablet to take by mouth with water. 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.

If you or your child are unable to swallow the 20 mg tablet whole, you may break them in half on the score mark.

If you or your child are unable to swallow the 20 mg tablets whole or in half, the tablets can be dissolved in 1 teaspoon (5 mL) of water in a drinking cup (no more than 5 tablets). You can drink this mixture immediately or to make taking it easier, add at least 1 teaspoon (5 mL) of additional water, milk product, apple juice, orange juice, cranberry juice, or a carbonated beverage, or alternatively, a soft food may be added. Then, swallow the entire mixture immediately. After taking the dose, rinse the cup with a small amount of additional liquid or soft food and take it immediately to be sure that you receive the entire dose. If you need more than five 20 mg-tablets of bedaquiline, repeat the steps above until you reach your prescribed dose.

Alternatively, to make it easier to swallow, you can also crush the 20 mg tablets and add to a soft food such as yogurt, applesauce, mashed banana, or oatmeal and swallow the entire mixture immediately. After taking the dose, add a small amount of additional soft food and take it immediately to be sure that you receive the entire dose.

If you have a nasogastric (NG) tube, your doctor or pharmacist will explain how to prepare bedaquiline to give through an NG tube.

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.