Drug Interactions between mibefradil and nintedanib

MONITOR: Coadministration with inhibitors of P-glycoprotein (P-gp) and CYP450 3A4 may increase the plasma concentrations of nintedanib, which is a substrate of the efflux transporter and a minor substrate of the isoenzyme. In a dedicated drug interaction study, administration of nintedanib with the potent P-gp and CYP450 3A4 inhibitor, ketoconazole, increased nintedanib peak plasma concentration (Cmax) by 83% and systemic exposure (AUC) by 61%. No data are available for use with other, less potent inhibitors.

MANAGEMENT: Caution is advised if nintedanib is prescribed in combination with P-gp and CYP450 3A4 inhibitors. Pharmacologic response to nintedanib should be monitored more closely whenever a CYP450 3A4/P-gp inhibitor is added to or withdrawn from therapy, and the nintedanib dosing adjusted or interrupted as necessary in accordance with the product labeling. Patients should be closely monitored for increased adverse effects such as liver enzyme and bilirubin elevations, diarrhea, nausea, vomiting, gastrointestinal perforation, bleeding, and arterial thromboembolic events (e.g., myocardial infarction).

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