Drug Interaction Report

ADJUST DOSE: Coadministration with oteseconazole may increase the plasma concentrations of drugs that are substrates of the breast cancer resistance protein (BCRP), which may increase the risk of adverse effects associated with these drugs. The proposed mechanism is decreased clearance due to inhibition of BCRP-mediated intestinal and/or hepatic transport by oteseconazole. When administered with rosuvastatin, a BCRP substrate, oteseconazole increased rosuvastatin peak plasma concentration (Cmax) and systemic exposure (AUC 0-24h) by 118% and 114%, respectively.

MANAGEMENT: When concomitant use of oteseconazole is required, the lowest possible starting dosage or a reduction of the existing dosage of BCRP substrates should be considered. The prescribing information for concomitant medications should be consulted to assess the benefits versus risks of coadministration of a BCRP inhibitor like oteseconazole and for any dosage adjustments that may be required. Patients should be closely monitored for clinical response and adverse effects, and the dosage(s) of concomitant medication(s) further adjusted as necessary.

ADJUST DOSING INTERVAL: Food enhances the oral bioavailability of oteseconazole. When administered with a high-fat, high-calorie meal (800 to 1000 calories; 50% fat), oteseconazole peak plasma concentration (Cmax) and systemic exposure (AUC 0-72h) increased by 45% and 36%, respectively. However, no significant differences were observed with a low-fat, low-calorie meal.

MANAGEMENT: Oteseconazole should be administered with food.