Sirturo

Bedaquiline 20 mg Tablets

(bed AK wi leen)

Sirturo

In one study, 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. Talk with your doctor if you are taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). 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). This drug is taken with other drugs. Be sure you know about the warnings, benefits, and risks of these other drugs. Talk with the doctor if you have questions or concerns about any of the drugs.

If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had. 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 take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this drug, like certain drugs that are used for HIV, infections, or seizures. There are many drugs that must not be taken with this drug. This is not a list of all drugs or health problems that interact with this drug. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

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. Avoid drinking alcohol while taking this drug. Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: 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, swallowing, 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. Very bad dizziness. Coughing up blood.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: Headache. Joint pain. Upset stomach. Stomach pain. Not hungry. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely. Take with food. Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well. It is important that you do not miss or skip a dose of this drug during treatment. The tablets may be split based on the dose that is needed. If splitting the tablets, only split on the score line. If you cannot swallow tablets, the tablet may be crushed and added to a small amount of soft food. Take the mixture right away. Do not store for future use. You may also mix the tablets in water in a cup. Use 1 teaspoon (5 mL) of water for up to 5 tablets. If needed, you can add at least 1 more teaspoon of drink or soft food. Mix well and take right away. If your dose is more than 5 tablets, do these steps again. Add more drink or soft food to rinse the cup and take right away. Those who have feeding tubes may use this drug. Use as you have been told. Flush the feeding tube after this drug is given.

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. All weeks: If it is less than 24 hours until your next dose, skip the missed dose and go back to your normal time. Do not take more than 1 dose of this drug in 24 hours unless told to do so by your doctor. If you are not sure what to do if you miss a dose, call your doctor.

Store at room temperature protected from light. Store in a dry place. Do not store in a bathroom. Keep lid tightly closed. Store in the original container. Do not take out the antimoisture cube or packet. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

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. 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 have any questions about this drug, please talk with the doctor, 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.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.