Bedaquiline

Type of Medication: Antibiotic

Indications: Treatment of Mycobacterium abscessus infections

Side Effects: arthralgia,  chest pain, nausea, headache, haemoptysis,  QTc prolongation, increases in LFTs. Not licensed for the treatment of NTM in the UK.  Clinicians are advised to monitor patients closely and detailed information provided to patient relating to potential side effects and serious complications including death, heart rhythm abnormalities and/or hepatitis.

Route of administration: Adult (Oral)

Dose: Adults (aged 18–64 years): 400 mg daily for the first 2 weeks, followed by 200 mg three times per week for the remaining 22 weeks (maximum duration=6 months).

Administration: Bedaquiline should be taken with food and avoid alcohol.

Monitoring: ECG: baseline, 2 weeks, then every month. U&Es, calcium magnesium and LFT at baseline, and repeated monthly.

BTS guidelines

Cystic Fibrosis Foundation and European Cystic Fibrosis Society consensus recommendations

Examples of some Drug Interactions

Interacting drug: antiarrhythmics: risk of prolonged QT interval (eg, amiodarone, sotalol, procainamide, disopyramide and quinidine)

Interacting drug: antiemetics: increased risk of QT prolongation (eg, domperidone, metoclopramide, 5HT3 antagonists)

Interacting drug: antiretrovirals: limited data

Interacting drug: antidepressants, tricyclic: risk of prolonged QT interval

Interacting drug: antipsychotics (thioridazine, haloperidol, chlorpromazine, trifluoperazine, percycline, prochlorperazine, fluphenazine, sertindole and pimozide): risk of prolonged QT interval

Interacting drug: azole antifungals (eg, ketoconazole, voriconazole, itraconazole, fluconazole): increased exposure to bedaquiline; avoid coadministration for more than 14 days

Interacting drug: carbamazepine: accelerated metabolism of bedaquiline resulting in reduced effect; avoid coadministration

Interacting drug: chloroquine and hydroxychloroquine: risk of prolonged QT interval

Interacting drug: clofazimine: risk of prolonged QT interval

Interacting drug: CYP3A4 inducers: accelerated metabolism of bedaquiline resulting in reduced effect; avoid coadministration

Interacting drug: CYP3A4 inhibitors: reduced metabolism resulting in increased serum concentrations of bedaquiline; avoid prolonged coadministration for more than 14 days

Interacting drug: fluoroquinolones: risk of prolonged QT interval.

Interacting drug: ivacaftor: possible increased serum levels of bedaquiline – monitor for increased adverse effects.

Interacting drug: macrolides: risk of prolonged QT interval. Avoid co-administration for more than 14 days.

Interacting drug:  Orkambi (lumacaftor/ivacaftor): accelerated metabolism of bedaquiline, avoid co-administration.

Interacting drug: phenytoin: accelerated metabolism of bedaquiline resulting in reduced effect. Avoid co-administration.

Interacting drug: rifampicin, rifabutin and rifapentine: accelerated metabolism of bedaquiline resulting in reduced effect; avoid coadministration

Interacting drug: statins: avoid co administration.