Drug Interaction Report

MONITOR: Neither the leukapheresis procedure nor sipuleucel-T have been studied for use in combination with chemotherapy or immunosuppressive agents (e.g., systemic corticosteroids). Since sipuleucel-T is designed to stimulate the immune system, concurrent use of myelo- or immunosuppressive agents may alter the efficacy and/or safety of sipuleucel-T.

MANAGEMENT: Patients should be carefully evaluated to determine whether it is medically appropriate to reduce or discontinue chemotherapy or immunosuppressive agents prior to treatment with sipuleucel-T.

ADJUST DOSING INTERVAL: Food increases the systemic exposure of givinostat. An open-label, randomized, crossover, single dose food effect study conducted in 12 healthy males used givinostat liquid filled capsules. Subjects received a single oral dose of givinostat (100 mg) in the fasting state or after a high-fat standard meal, with a washout period of at least 1 week in between. The high-fat standard meal resulted in an increase in systemic exposure (AUC) and maximum plasma concentration (Cmax) of about 40% and 23%, respectively, when compared to the fasted state. Additionally, the time to maximum concentration (Tmax) was delayed slightly from 2 to 3 hours.

MANAGEMENT: Givinostat should be administered with food to increase its absorption. In the case of the oral suspension, this can also help mask its bitter taste.