Drug Interaction Report

ADJUST DOSE: Coadministration with potent inhibitors of CYP450 3A4 may significantly increase the plasma concentrations of daclatasvir, which is primarily metabolized by the isoenzyme. When a single 10 mg dose of daclatasvir was administered following pretreatment with the potent CYP450 3A4 inhibitor ketoconazole (400 mg once daily), daclatasvir peak plasma concentration (Cmax) and systemic exposure (AUC) increased by 1.6- and 3-fold, respectively.

MANAGEMENT: A reduction in the dosage of daclatasvir to 30 mg once daily is recommended when used with potent CYP450 3A4 inhibitors.

GENERALLY AVOID: Alcohol may potentiate some of the pharmacologic effects of CNS-active agents. Use in combination may result in additive central nervous system depression and/or impairment of judgment, thinking, and psychomotor skills.

MANAGEMENT: Patients receiving CNS-active agents should be warned of this interaction and advised to avoid or limit consumption of alcohol. Ambulatory patients should be counseled to avoid hazardous activities requiring complete mental alertness and motor coordination until they know how these agents affect them, and to notify their physician if they experience excessive or prolonged CNS effects that interfere with their normal activities.