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.

Food enhances the oral absorption and bioavailability of tenofovir, the active entity of tenofovir disoproxil fumarate. According to the product labeling, administration of the drug following a high-fat meal increased the mean peak plasma concentration (Cmax) and area under the concentration-time curve (AUC) of tenofovir by approximately 14% and 40%, respectively, compared to administration in the fasting state. However, administration with a light meal did not significantly affect the pharmacokinetics of tenofovir compared to administration in the fasting state. Food delays the time to reach tenofovir Cmax by approximately 1 hour. Tenofovir disoproxil fumarate may be administered without regard to meals.