Drug Interaction Report

MONITOR: Coadministration with vibegron may increase the plasma concentrations and effects of drugs that are substrates of the P-glycoprotein (P-gp) efflux transporter. The exact mechanism for this interaction has not been established. When a single dose of vibegron (100 mg) was administered to healthy volunteers, the peak plasma concentration (Cmax) and systemic exposure (AUC) of the P-gp substrate digoxin increased by 21% and 11%, respectively. The risk of adverse reactions related to these substrates may be increased.

MANAGEMENT: Caution is advised if vibegron is coadministered with substrates of P-gp, particularly sensitive substrates or those with a narrow therapeutic range. The prescribing information for concomitant medications should be consulted to assess the benefits versus risks of coadministration and for any dosage adjustments that may be required.

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.