bedaquiline fumarate: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
bedaquiline fumarate: clinical details
Prescribing considerations
- Initiate and monitor treatment through a clinician experienced in managing resistant tuberculosis.
- Use only within an appropriate combination regimen containing other agents to which the isolate is susceptible or likely to be susceptible.
- Assess baseline cardiac history, concomitant QT-prolonging medicines, electrolytes and liver function.
- Clinical data are lacking for extrapulmonary tuberculosis, latent infection, non-tuberculous mycobacteria and drug-susceptible tuberculosis.
- Severe hepatic impairment is not studied and use is not recommended; use caution in severe renal impairment or end-stage renal disease.
- Avoid moderate or strong systemic CYP3A4 inducers and minimise other hepatotoxic exposures.
Contraindications and cautions
- Hypersensitivity to bedaquiline or any listed excipient.
- The selected tablet contains lactose and should not be used in rare hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
Monitoring
- Obtain a baseline ECG and continue regular QTc monitoring.
- Check potassium, calcium and magnesium at baseline, correct abnormalities and repeat if QT prolongation occurs.
- Monitor ALT, AST, alkaline phosphatase and bilirubin at baseline, regularly during treatment and when clinically indicated.
- Review urgently following syncope or suspected arrhythmia.
- Review the regimen if clinically important QT prolongation, ventricular arrhythmia or significant hepatotoxicity develops.
Clinical pharmacology
Bedaquiline inhibits mycobacterial ATP synthase. It is highly protein-bound, is mainly metabolised through CYP3A4 to a less active metabolite and has a very long terminal elimination phase reflecting slow release from tissues.
Formulation and product differences
- The selected uncoated tablet should be swallowed whole with water and taken with food.
- The selected tablet contains lactose monohydrate and should be stored in its original container or package to protect it from light.
bedaquiline fumarate preparations and strengths
Tablet
Route: Oral
Strengths: 20 mg, 100 mg
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.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.