Generic Name: bedaquiline (bed AK wi leen)
Brand Name: Sirturo
What is bedaquiline?
Bedaquiline is for use in adults and children at least 12 years old and weighing at least 66 pounds (30 kilograms).
Bedaquiline can cause serious and sometimes fatal side effects. bedaquiline should be used only if you have no other treatment options.
Bedaquiline may also be used for purposes not listed in this medication guide.
Bedaquiline 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.
Bedaquiline can affect your heart rhythm, especially if you also take certain other medicines. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with bedaquiline.
Before taking this medicine
Tell your doctor if you have ever had:
heart problems or a heart rhythm disorder;
long QT syndrome (in you or a family member);
human immunodeficiency virus (HIV);
liver or kidney disease;
an electrolyte imbalance (such as low levels of calcium, potassium, or magnesium in your blood); or
an abnormal electrocardiogram or ECG (sometimes called an EKG).
Follow your doctor's instructions about using bedaquiline 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.
How should I take bedaquiline?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
Take with food and a full glass of water.
Bedaquiline 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.
You may receive this medicine in a doctor's office or other clinic setting.
Swallow the tablet whole and do not crush, chew, or break it.
Bedaquiline must be given in combination with other tuberculosis medications and it should not be used alone. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.
Use this medicine 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.
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 this medicine in the original container at room temperature away from moisture, heat, and light. Do not use bedaquiline after the expiration date on the label has passed.
What happens if I miss a dose?
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.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking bedaquiline?
Avoid drinking alcohol. It may increase your risk of liver damage.
Avoid taking an herbal supplement.
Bedaquiline side effects
Get emergency medical help if you have signs of an allergic reaction: 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);
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 side effects may include:
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.
Bedaquiline dosing information
Usual Adult Dose for Tuberculosis -- Resistant:
-Week 1 and Week 2: 400 mg orally once a day.
-Week 3 to Week 24: 200 mg orally 3 times per week, with at least 48 hours between doses.
-Duration of therapy: 24 weeks
-Required testing prior to treatment: Susceptibility information for the background regimen against Mycobacterium tuberculosis isolate if possible; ECG; serum potassium, calcium, and magnesium concentrations; and liver enzymes.
-Use this drug only in combination with 3 other antimycobacterial drugs to which the patient's multi-drug resistant tuberculosis (MDR-TB) isolate has been shown to be susceptible in vitro. If in vitro testing results are unavailable, treatment may be initiated in combination with at least 4 other drugs to which the patient's MDR-TB isolate is likely to be susceptible.
-Administer by directly observed therapy (DOT).
-This drug should be reserved for use when an effective treatment regimen cannot otherwise be provided.
Use: Part of combination therapy in the treatment of adults 18 years and older with pulmonary multi-drug resistant tuberculosis (MDR-TB).
What other drugs will affect bedaquiline?
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.
Bedaquiline 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, or malaria.
Many drugs can affect 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.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Copyright 1996-2018 Cerner Multum, Inc. Version: 3.01.
More about bedaquiline
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
- En Español
- Drug class: diarylquinolines
Other brands: Sirturo