Drug Interaction Report

MONITOR: There are no data regarding the use of live, unattenuated Adenovirus Type 4 and Type 7 vaccine during treatment with immunosuppressive therapies, including alkylating agents, antimetabolites, radiation, some antirheumatic agents, high dosages of corticosteroids or adrenocorticotropic agents, and long-term topical or inhaled corticosteroids. It is not known whether immunosuppressed patients may have an increased risk of adverse reactions or a decreased or suboptimal immunologic response to the vaccine.

MANAGEMENT: The safety and efficacy of live, unattenuated Adenovirus Type 4 and Type 7 vaccine have not been established in patients receiving immunosuppressive therapies. Caution is advised.

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.