- 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.
- This drug may cause a long QT on ECG. Talk with the doctor.
- 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 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.
- If you are taking rifampin, rifapentine, or rifabutin, talk with doctor. These drugs may make this drug less effective.
- Tell dentists, surgeons, and other doctors that you use this drug.
- 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.
- 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.
- A fast heartbeat.
- A heartbeat that does not feel normal.
- Very bad dizziness or passing out.
- Coughing up blood.
- Joint pain.
- Upset stomach.
- Not hungry.
- This drug is used with other drugs. Talk with your doctor.
- Take as you have been told, even if you feel well.
- To gain the most benefit, do not miss doses.
- Take with food.
- Swallow whole. Do not chew, break, or crush.
- Take with a full glass 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 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, pharmacist, or other health care provider.
- This drug comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this drug is refilled.
- 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.
If you have any questions or concerns, talk with a member of your healthcare team. You can reach them Monday through Friday from 9:00 am to 5:00 pm at ____________________. After 5:00 pm, during the weekend, and on holidays, please call____________________. If there’s no number listed, or you’re not sure, call 212-639-2000.