Drug Interaction Report

MONITOR: Coadministration with daclatasvir may increase the plasma concentrations of drugs that are substrates of the P-glycoprotein (P-gp) transporter. The proposed mechanism is decreased clearance in the intestine, liver, and/or kidney due to inhibition of P-glycoprotein-mediated drug efflux by daclatasvir. When 0.125 mg once daily of digoxin, a P-gp probe substrate, was administered with 60 mg once daily daclatasvir, digoxin peak plasma concentration (Cmax) and systemic exposure (AUC) increased by 65% and 27%, respectively.

MANAGEMENT: Caution is advised when daclatasvir is used concurrently with drugs that are known P-gp substrates, particularly those with a narrow therapeutic range. Dosage adjustments as well as clinical and laboratory monitoring may be appropriate for some drugs whenever daclatasvir is added to or withdrawn from therapy.