Drug Interaction Report

GENERALLY AVOID: Coadministration with other myelosuppressive agents may potentiate the hematologic toxicities of ropeginterferon alfa-2b. Decreased peripheral blood counts have been reported in patients receiving interferon alfa products, including ropeginterferon alfa-2b. In two open label trials consisting of 178 patients receiving ropeginterferon alfa-2b monotherapy (dosed every 2 to 4 weeks) for the treatment of polycythemia vera, 80% of whom were exposed for 12 months or longer, leukopenia occurred in 20% of patients and thrombocytopenia in 19% of patients. Leukopenia, thrombocytopenia and anemia of grade 3 or higher occurred in 2%, 2% and 1% of patients, respectively. Moreover, infections occurred in 48% of patients, while serious infections occurred in 8% of patients.

MANAGEMENT: Concomitant use of ropeginterferon alfa-2b with other myelosuppressive agents should be avoided when possible. Otherwise, close clinical and laboratory monitoring are advised. Complete blood counts should be performed at baseline, during titration, and every 3 to 6 months or more frequently as clinically indicated during the maintenance phase.

ADJUST DOSING INTERVAL: Food enhances the oral bioavailability of umbralisib. When a single oral dose of umbralisib was administered with a high-fat, high-calorie meal (approximately 917 calories; 171 calories from protein, 232 calories from carbohydrate, 502 calories from fat) in healthy subjects, umbralisib peak plasma concentration (Cmax) and systemic exposure (AUC) increased by 115% and 61%, respectively, compared to administration under fasted conditions.

MANAGEMENT: Umbralisib should be administered with food at approximately the same time each day.