Bedaquiline Tablets

What is this medication?

BEDAQUILINE (bed AK wi leen) treats tuberculosis (TB), an infection caused by bacteria. It belongs to a group of medications called antibiotics. It will not treat colds, the flu, or infections caused by viruses.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Sirturo

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Alcohol use
• Heart disease
• Heart failure
• High or low levels of electrolytes, such as magnesium or potassium, in your blood
• Irregular heartbeat or rhythm
• HIV or AIDS
• Liver disease
• Slow heart beat
• Thyroid disease
• An unusual or allergic reaction to bedaquiline, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it with food. Take each dose exactly as prescribed on the prescription label. Do not skip doses. Skipping doses can make the infection resistant to this and other medications. You may also spread the infection to others. Keep taking this medication unless your care team tells you to stop. Your care team may have someone watch you take each dose. This can help you manage your treatment.

A special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 5 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

What may interact with this medication?

Do not take this medication with any of the following:

• Cisapride
• Dronedarone
• Ketoconazole
• Levoketoconazole
• Pimozide
• Posaconazole
• Thioridazine
• Ziprasidone

This medication may also interact with the following:

• Alcohol
• Antiviral medications for HIV or AIDS, such as efavirenz
• Other antibiotics, such as rifampin, rifapentine, rifabutin
• Other medications that cause heart rhythm changes

Other medications may affect the way this medication works. Talk with your care team about all the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work done before or while taking this medication. Your care team may also give your a test called an electrocardiogram (ECG) to check your heart before and during treatment.

Talk to your care team before breastfeeding. Changes to your treatment plan may be needed.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Headache
• Joint pain
• Muscle pain
• Nausea
• Stomach pain
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep it in the original container. Protect from light and moisture. Keep the container tightly closed. Do not throw out the packet in the container. It keeps the medication dry. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix it with cat litter, dirt, coffee grounds, or another unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.