Drug Interaction Report

GENERALLY AVOID: Coadministration with darolutamide may increase the plasma concentrations of drugs that are substrates of the breast cancer resistance protein (BCRP) transporter. The proposed mechanism is decreased clearance due to inhibition of BCRP-mediated intestinal and hepatobiliary efflux by darolutamide. When rosuvastatin, a known BCRP substrate, was administered concomitantly with darolutamide, mean rosuvastatin peak plasma concentration (Cmax) and systemic exposure (AUC) increased by approximately 5-fold.

MANAGEMENT: Concomitant use of darolutamide with drugs that are BCRP substrates should be avoided when possible. If coadministration is required, patients should be monitored carefully for increased adverse reactions of these drugs and dosing adjusted as necessary.

ADJUST DOSING INTERVAL: Oral cladribine may increase the bioavailability of other drugs, which may increase the risk or severity of adverse reactions. Cladribine tablets may contain hydroxypropyl betadex, which could form a complex with the active ingredients of other drugs, especially agents with low solubility. The clinical relevance of this interaction remains unknown.

MANAGEMENT: Administration of oral cladribine should be separated from any other oral drug by at least 3 hours.

ADJUST DOSING INTERVAL: Food enhances the oral absorption of darolutamide. According to the prescribing information, bioavailability of darolutamide increased by 2.0 to 2.5-fold when administered with food. A similar increase in exposure was observed for the active metabolite keto-darolutamide.

MANAGEMENT: Darolutamide should be administered with food.