Drug Interaction Report

ADJUST DOSING INTERVAL: The safety and efficacy of hematopoietic growth factors such as colony-stimulating factors (G-CSF and GM-CSF) and stem cell factors (SCF) given simultaneously with cancer chemotherapy have not been established. Theoretical concerns exist regarding their concomitant administration because hematopoietic growth factors stimulate myeloid cell proliferation while antineoplastic agents primarily target rapidly dividing cells.

MANAGEMENT: Because of the potential sensitivity of rapidly dividing myeloid cells to cancer chemotherapy, hematopoietic growth factors should not be used within 24 hours before or 24 hours after administration of antineoplastic agents.

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.