Drug Interaction Report

GENERALLY AVOID: Coadministration with vimseltinib may increase the plasma concentrations of drugs that are substrates of the P-glycoprotein (P-gp) efflux transporter. The proposed mechanism, based on in vitro data, involves decreased clearance due to inhibition of P-gp by vimseltinib. Based on model-informed drug interaction studies, coadministration of the P-gp substrate dabigatran with vimseltinib (30 mg twice weekly) is predicted to increase the systemic exposure (AUC) and peak plasma concentration (Cmax) of dabigatran by 2 to 3-fold. However, if dabigatran is administered 4 hours after vimseltinib (30 mg twice weekly), the AUC and Cmax are predicted to increase by only up to 1.3-fold. Clinical data are not available.

MANAGEMENT: Concomitant use of vimseltinib with P-gp substrates should generally be avoided. If coadministration is considered necessary, vimseltinib should be taken at least 4 hours prior to the P-gp substrate. The individual product labeling of the P-gp substrate should be consulted for further guidance.

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.