Drug Interactions between dabigatran and dronedarone

MONITOR CLOSELY: Coadministration with potent inhibitors of P-glycoprotein such as dronedarone may significantly increase the bioavailability of dabigatran following oral administration of dabigatran etexilate, which is a substrate of the efflux transporter. In pharmacokinetic studies, dabigatran systemic exposure (AUC) increased by 1.7- to 2-fold during coadministration with dronedarone compared to administration alone.

MANAGEMENT: Caution is advised if dabigatran is used in combination with dronedarone. Pharmacologic response to dabigatran should be monitored more closely whenever dronedarone is added to or withdrawn from therapy, and the dabigatran dosage adjusted as necessary. Patients should be monitored for the development of anemia and bleeding complications during coadministration. In patients with moderate renal impairment (CrCl 30 to 50 mL/min), concomitant use with dronedarone can be expected to produce dabigatran exposure similar to that observed in severe renal impairment. Therefore, a reduction in the dabigatran dosage to 75 mg twice daily should be considered. The use of dabigatran in combination with dronedarone in patients with severe renal impairment (CrCl 15 to 30 mL/min) should be avoided.