Key Considerations for the Use of Bedaquiline [Bdq]

Because of the risk for potential drug-drug interactions, the following medications are not allowed during the 24-week administration of Bedaquiline (Bdq) and up to one month after the last dose of Bdq:

• Systemic use of moderate and strong CYP3A4 inhibitors, e.g., Azole antifungals such as Ketoconazole, Voriconazole, Itraconazole, Fluconazole; Ketolides such as Telithromycin; and Macrolide antibiotics other than Azithromycin, for more than 2 consecutive weeks.
• Systemic use of strong CYP3A4 inducers, e.g., Phenytoin, Carbamazepine, Phenobarbital.
• St. John’s wort and Rifamycins (Rifampin, Rifabutin, Rifapentine).
• Cholesterol-lowering medications of the “statin” class.

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Bdq should be used with caution in People Living with HIV (PLHIV) who are being treated with Antiretrovirals (ARVs) as Bdq exhibits drug-drug interactions with Efavirenz, prolonging the QT interval with Lopinavir/ Ritonavir. 

Bdq should also be used with caution in patients with comorbidities (such as diabetes) or persons with drug or alcohol use, due to limited or no information.

Other second-line drugs that are likely to be administered with Bdq, notably Fluoroquinolone (FQs) and Clofazimine (Cfz), may potentially increase the risk of cardiotoxicity.

Regular monitoring of patients to be done for cardiac dysrhythmias or QT interval prolongation (using ECG), and for electrolyte imbalances (especially, serum potassium) when used along with the other cardiotoxic drugs.

Resources

• Guidelines for Programmatic Management of Tuberculosis in India, 2021.
• WHO Consolidated Guidelines on Tuberculosis: Module 4 - Treatment: Drug-resistant TB Treatment, 2020.

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