Drug Interactions between dabigatran and Mavyret

MONITOR CLOSELY: Coadministration of dabigatran etexilate with glecaprevir-pibrentasvir may significantly increase the plasma concentrations of dabigatran. The proposed mechanism is inhibition of the P-glycoprotein (P-gp)-mediated renal tubular secretion of dabigatran by glecaprevir and pibrentasvir, both of which are inhibitors of the transporter. In 11 study subjects, administration of a single 150 mg dose of dabigatran etexilate with glecaprevir-pibrentasvir 300 mg-120 mg once daily increased dabigatran peak plasma concentration (Cmax) and systemic exposure (AUC) by approximately 2.1- and 2.4-fold, respectively, compared to administration of dabigatran etexilate alone.

MANAGEMENT: Caution is advised if dabigatran is used in combination with glecaprevir-pibrentasvir. Pharmacologic response to dabigatran should be monitored more closely whenever glecaprevir-pibrentasvir is added to or withdrawn from therapy, and the dabigatran dosage adjusted as necessary.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 potent P-gp inhibitors can generally 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. Based on the magnitude of interaction reported, concomitant use of dabigatran with glecaprevir-pibrentasvir in patients with severe renal impairment (CrCl 15 to 30 mL/min) should probably be avoided.