- More deaths were seen in people taking this drug compared to people not taking it. The cause of this is not known. This drug is only for use when other drugs cannot be used.
- A type of abnormal heartbeat (prolonged QT interval) can happen with this drug. Call your doctor right away if you have a fast heartbeat, a heartbeat that does not feel normal, or if you pass out.
- Your doctor will watch your heartbeat with a test called an ECG.
- Before taking this drug, tell your doctor if you are taking any drugs that can raise the chance of a heartbeat that is not normal. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
- It is used to treat TB (tuberculosis).
- If you have an allergy to bedaquiline or any other part of this drug.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you are taking any of these drugs: Efavirenz, rifabutin, rifampin, or rifapentine.
- If you are taking any drugs that can raise the chance of liver problems. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
- Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- You will need an ECG before starting this drug and during treatment. Talk with your doctor.
- Avoid drinking alcohol while taking this drug.
- Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
- Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
- 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.
- Joint pain.
- Upset stomach.
- Not hungry.
- This drug is used with other drugs. Talk with your doctor.
- Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
- To gain the most benefit, do not miss doses.
- Take with food.
- Swallow whole with a drink of water.
Weeks 1 and 2:
- Skip the missed dose and go back to your normal time.
Week 3 or more:
- Take a missed dose as soon as you think about it and go back to your normal time.
- Do not take 2 doses at the same time or extra doses.
- Store in the original container at room temperature.
- Protect from light.
- Store in a dry place. Do not store in a bathroom.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else’s drugs.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.