Sirturo is an antibiotic that is used together with other medications to treat tuberculosis of the lungs that has been resistant to other antibacterial medications.

Sirturo is for use in adults and children at least 5 years old and weighing at least 33 pounds (15 kilograms).

Sirturo can cause serious and sometimes fatal side effects. This medicine should be used only if you have no other treatment options.

Sirturo can cause serious and sometimes fatal side effects. This medicine should be used only if you have no other treatment options. Use only the prescribed dose of this medication, and follow all patient instructions for safe use.

Sirturo can cause a serious side effect on your heart. Tell your doctor if you have fast or irregular heartbeats and sudden dizziness, like you might pass out.

Take Sirturo exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

You may receive Sirturo in a doctor's office or other clinic setting.

Sirturo is usually taken every day for 2 weeks, and then only 3 times per week (at least 48 hours between doses) for the next 22 weeks. Follow your doctor's dosing instructions very carefully. You may need to take fewer tablets for each dose after the first 2 weeks of treatment.

Always take Sirturo with food.

Take the 100-milligram (mg) tablet with water. Swallow the tablet whole and do not crush, chew, or break it.

The 20-mg tablet may be broken along the split line if needed.

If you cannot swallow a 20-mg tablet whole, you may dissolve the tablet in water, and then mix it with a beverage or soft food. Read and carefully follow all instructions about mixing the 20-mg tablet to make it easier to swallow. Ask your doctor or pharmacist if you do not understand these instructions.

Bedaquiline doses are based on weight in children and/or teenagers. Your child's dosage may change if the child gains or loses weight.

Use Sirturo for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication.

Sirturo must be given in combination with other tuberculosis medications and should not be used alone. Use all medications as directed and read all medication guides you receive. Do not change your dose or stop using a medicine without your doctor's advice.

You may need frequent blood tests. Your heart function may also need to be checked with an electrocardiograph or ECG (sometimes called an EKG).

Store Sirturo in the original container at room temperature away from moisture, heat, and light. Do not use Sirturo after the expiration date on the label has passed.

Usual Adult Dose of Sirturo for Tuberculosis -- Resistant:

Weeks 1 and 2: 400 mg orally once a day
Weeks 3 to 24: 200 mg orally 3 times a week, with at least 48 hours between doses
Duration of therapy: 24 weeks

Comments:
-Alcohol should be avoided during treatment.
-Treatment should be given by directly observed therapy (DOT).
-This drug was approved based on sputum culture conversion time in clinical trials; continued approval may be based upon verification and clinical benefit in confirmatory trials.
-Use of this drug should be limited to infections where effective treatment regimens cannot otherwise be provided.
-Treatment should be used with at least 3 other drugs to which the in-vitro multidrug resistant tuberculosis (MDR-TB) isolate has been shown to be susceptible OR with at least 4 other drugs to which the isolate is likely to be susceptible if in-vitro results are unavailable.

Use: Part of combination therapy in the treatment of pulmonary MDR-TB caused by Mycobacterium tuberculosis

Usual Pediatric Dose of Sirturo for Tuberculosis -- Resistant:

12 years and older:
30 kg and over:
-Weeks 1 and 2: 400 mg orally once a day
-Weeks 3 to 24: 200 mg orally 3 times a week, with at least 48 hours between doses
-Duration of therapy: 24 weeks

Comments:
-Alcohol should be avoided during treatment.
-Treatment should be given by DOT, and should be given in combination with other antimycobacterial agents.
-This drug was approved based on sputum culture conversion time in clinical trials; continued approval may be based upon verification and clinical benefit in confirmatory trials.
-Use of this drug should be limited to infections where effective treatment regimens cannot otherwise be provided.
-Treatment should be used with at least 3 other drugs to which the in-vitro MDR-TB isolate has been shown to be susceptible OR with at least 4 other drugs to which the isolate is likely to be susceptible if in-vitro results are unavailable.

Use: Part of combination therapy in the treatment of pulmonary MDR-TB caused by M tuberculosis

To make sure Sirturo is safe for you, tell your doctor if you have ever had:

• heart problems or a heart rhythm disorder;

• underactive thyroid;

• long QT syndrome (in you or a family member);

• human immunodeficiency virus (HIV);

• liver or kidney disease; or

• an electrolyte imbalance (such as low blood levels of calcium, potassium, or magnesium in your blood).

Follow your doctor's instructions about using Sirturo if you are pregnant. Having tuberculosis during pregnancy could harm both mother and baby.

If you are breastfeeding, tell your doctor if you notice decreased appetite, sleepiness, nausea, stomach pain or swelling, dark urine, clay-colored-stools, or yellowing of the skin or eyes in the nursing baby.

If you miss a dose during the first 2 weeks of treatment: Skip the missed dose and use your next dose at the regular time.

If you miss a dose during week 3 or later: Take the dose as soon as you can and keep taking the medicine on the 3 times per week schedule.

Do not use two doses at one time.

Call your doctor for instructions if you are not sure what to do if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid drinking alcohol. It may increase your risk of liver damage.

Avoid taking an herbal supplement.

Get emergency medical help if you have signs of an allergic reaction to Sirturo: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

• chest pain;

• coughing up blood or vomit that looks like coffee grounds; or

• liver problems - loss of appetite, stomach pain (upper right side), tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Sirturo side effects may include:

• coughing up blood;

• chest pain;

• nausea, stomach pain;

• headache;

• joint pain; or

• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Sirturo can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Many drugs can interact with bedaquiline. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.