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 ( Web Site) 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 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.
HOW should this medicine be used?
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; do not crush them.
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.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
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.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: carbamazepine (Equetro, Tegretol, Teril, others); certain medications for human immunodeficiency virus (HIV) infection including efavirenz (Sustiva, in Atripla), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra, in Viekira Pak); itraconazole (Onmel, Sporanox); ketoconazole (Nizoral); nefazodone; phenobarbital; phenytoin (Dilantin); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); and rifapentine (Priftin). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with bedaquiline, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
tell your doctor what herbal products you are taking, especially St. John's wort.
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 breast-feeding. If you become pregnant while you are taking bedaquiline, call your doctor.
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. If you miss a dose during the remaining weeks of your treatment, take the missed dose as soon as you remember it. Do not take a double dose to make up for a missed one.
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:
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:
loss of appetite
yellowing of the skin or eyes
dark colored urine
light colored bowel movements
pain in the upper right area of the stomach
coughing up blood
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 ( Web Site ) 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).
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. Web Site
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 ( Web Site) 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 Web Site. 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.
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