Drug Interaction Report

GENERALLY AVOID: Coadministration of topical chloramphenicol with other agents that can cause bone marrow depression, aplastic anemia, or agranulocytosis may increase the risk and/or severity of hematologic toxicity. Chloramphenicol may be absorbed systemically from the eye, ear, and vagina. Bone marrow hypoplasia, including aplastic anemia and death, has been reported following topical use of chloramphenicol. However, systemic absorption following topical, ophthalmic, otic, and vaginal administration is generally minimal, and data concerning the incidence of blood dyscrasias following the use of topical chloramphenicol are not available.

MANAGEMENT: Concurrent use of topical chloramphenicol formulations with other bone marrow depressing agents should generally be avoided. If concomitant use on a long-term or intermittent basis is considered necessary, patients should be monitored for the development of hematologic adverse effects. Monitoring via full blood counts before and periodically during therapy may also be advisable.

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.