bedaquiline fumarate at a glance
Medicine class
Antimycobacterial diarylquinoline antibiotic
Licensed role
Pulmonary tuberculosis resistant to at least rifampicin and isoniazid
Combination treatment
Must be used with other appropriate tuberculosis medicines
Administration
Take with food and swallow the selected tablets whole with water
Key monitoring
ECGs, electrolytes and liver tests are required
What is bedaquiline fumarate used for?
UK-licensed use represented by the selected product:
As part of an appropriate combination regimen for adults and eligible children with pulmonary tuberculosis caused by Mycobacterium tuberculosis resistant to at least rifampicin and isoniazid.
How does bedaquiline fumarate work?
Bedaquiline blocks mycobacterial ATP synthase, an enzyme tuberculosis bacteria need to generate energy. This disrupts energy production and has bactericidal activity against both replicating and non-replicating tubercle bacilli.
bedaquiline fumarate preparations and strengths
Tablet
Route: Oral
Strengths: 20 mg, 100 mg
How to take bedaquiline fumarate
Take bedaquiline exactly as directed by the specialist tuberculosis team and with the other prescribed tuberculosis medicines.
Take with food because this substantially increases absorption.
Swallow the selected tablets whole with water.
Do not stop treatment or omit doses without discussing this with the tuberculosis team.
bedaquiline fumarate side effects
Common or expected effects
- Nausea or vomiting
- Headache or dizziness
- Joint pain
- Raised liver enzymes on blood tests
- QT prolongation on an ECG
- Diarrhoea
- Muscle aching or tenderness
Get urgent medical advice
- Fainting, which may indicate a significant heart-rhythm disturbance
- Clinically significant ventricular arrhythmia
- Marked liver-test abnormalities requiring prompt clinical review
bedaquiline fumarate in pregnancy
Experience during pregnancy is limited. As a precaution, bedaquiline should generally be avoided unless the specialist considers that the expected benefit outweighs the potential risks. Discuss pregnancy or plans for pregnancy promptly with the tuberculosis team.
bedaquiline fumarate while breastfeeding
Bedaquiline passes into human milk and infant exposure may approach maternal levels. The product information advises that people receiving bedaquiline should not breastfeed, so feeding options require specialist discussion.
bedaquiline fumarate interactions
The tuberculosis team should review all prescribed, non-prescribed and herbal products before and during treatment.
Rifampicin, rifapentine or rifabutin
These CYP3A4 inducers can reduce bedaquiline exposure and potentially reduce its therapeutic effect, so co-administration should be avoided.
Carbamazepine, phenytoin, efavirenz or etravirine
These moderate or strong CYP3A4 inducers may lower bedaquiline exposure and should generally be avoided.
St John's wort
This herbal CYP3A4 inducer may reduce bedaquiline exposure and should be avoided.
Common questions about bedaquiline fumarate
Answers are fully visible for fast scanning and source review.
Why is bedaquiline used for resistant tuberculosis?
It targets mycobacterial energy production through ATP synthase and is licensed within combination treatment for pulmonary tuberculosis resistant to at least rifampicin and isoniazid.
Can bedaquiline be used on its own?
No. It must be used with other appropriate tuberculosis medicines.
Why must bedaquiline be taken with food?
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.