Bedaquiline

IMPORTANT WARNING:

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 (https://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 medicine 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.

Are there OTHER USES for this medicine?

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

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.

What SPECIAL PRECAUTIONS should I follow?

Before taking bedaquiline,

• tell your doctor and pharmacist if you are allergic to bedaquiline, any other medications, or any of the ingredients in bedaquiline tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• some medications should not be taken with bedaquiline. Other medications may cause dosing changes or extra monitoring when taken with bedaquiline. Make sure you have discussed any medications you are currently taking or plan to take before starting bedaquiline with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking bedaquiline, please get the advice of your doctor or pharmacist.

• the following nonprescription or herbal products may interact with bedaquiline: St John's wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking bedaquiline. Do not start any of these medications while taking bedaquiline without discussing with your healthcare provider.

• tell your doctor if you have or have ever had HIV, or liver or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while you are taking bedaquiline, call your doctor. If you are breastfeeding, tell your doctor if your infant has yellow eyes or skin or changes in the color of their urine or stool.

• avoid drinking alcoholic beverages while you are taking bedaquiline. Drinking alcohol increases the risk that you will experience serious side effects from bedaquiline.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

If you miss a dose during the first 2 weeks of your treatment, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

If you miss a dose from week 3 throughout the remaining weeks of your treatment, take the missed dose with food as soon as you remember it and continue your 3 times a week dosing schedule. Make sure that there is at least 24 hours between taking the missed dose and the next scheduled dose. Do not take a double dose to make up for a missed one or take more than your weekly dose in a 7-day period.

What SIDE EFFECTS can this medicine cause?

Bedaquiline may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• joint pain
• headache
• rash

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• excessive tiredness
• loss of appetite
• nausea
• yellowing of the skin or eyes
• dark colored urine
• light colored bowel movements
• pain in the upper right area of the stomach
• fever
• coughing up blood
• chest pain

Bedaquiline may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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. https://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 (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

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.