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.
Side Effects Of Bedaquiline
Bedaquiline may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- joint pain
Some side effects can be serious. If you experience any of these symptoms or those listed in the WARNING section, call your doctor immediately or get emergency medical treatment:
- excessive tiredness
- 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
- chest pain
Bedaquiline may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
Warnings & Precautions
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 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 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.
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.
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.
All information has been provided courtesy of MedLinePlus from the National Library of Medicine and from the FDA.