Bedaquiline Disease Interactions

Bedaquiline causes QT prolongation. Use with drugs that prolong the QT interval may cause additive QT prolongation. Monitor ECG before initiation of treatment, and at least 2, 12, and 24 weeks after starting treatment and obtain serum potassium, calcium, and magnesium at baseline and correct if abnormal. Discontinue bedaquiline if significant ventricular arrhythmia or if QTcF interval prolongation of greater than 500 ms. develops. If syncope occurs, obtain an ECG to detect QT prolongation.

Bedaquiline can cause QT prolongation, which may lead to an increased risk for ventricular arrhythmias, including Torsade de Pointes. Use of bedaquiline should be avoided in patients with congenital long QT syndrome, known prolongation of the QTc interval, uncompensated heart failure, or severe left ventricular hypertrophy, hypothyroidism, and in patients with electrolytes abnormalities. It is recommended to obtain an ECG before initiation of treatment, and at least 2, 12, and 24 weeks after starting treatment and to discontinue treatment if significant ventricular arrhythmia or if QTcF interval prolongation of greater than 500 ms develops.

The use of bedaquiline might increase hepatic-related adverse events and lead to hepatotoxicity. It is recommended to avoid alcohol and other hepatotoxic drugs while on bedaquiline. Close monitoring is recommended in alcoholic patients as they are at a greater risk of hepatic toxicity. Liver function tests should be done at baseline, monthly while on treatment, and as needed thereafter and discontinuance of therapy if evidence of new or worsening liver dysfunction occurs as indicated by the manufacturer.

Bedaquiline population pharmacokinetic analysis indicated that mild to moderate hepatic impairment had no significant influence on bedaquiline pharmacokinetics. Close monitoring of liver function is recommended in patients with severe hepatic impairment as the pharmacokinetics of bedaquiline is unknown in these patients.

No dose adjustment is required for patients with mild or moderate renal impairment. Care should be exercised when using bedaquiline in patients with severe renal impairment or end-stage renal disease requiring hemodialysis or peritoneal dialysis. It is recommended to monitor patients closely for adverse events.