Nicotine Usage in Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants - Ondansetron

Nicotine Usage Information
Study Description
This master protocol included multiple drugs of interest (DOIs) being studied. The primary objective of this study was to evaluate the pharmacokinetics of commonly used drugs in the blood and breastmilk of lactating women and in the blood of breastfed infants. The secondary objective was to describe the safety profile of commonly used drugs in infants exposed to drugs in breastmilk. This clinical study report presents data for the DOI ondansetron. Ondansetron plasma and breastmilk samples were collected from lactating women and their infants (≤180 days of age) enrolled in this study. The concentrations of ondansetron in maternal plasma and breastmilk were summarized by 3-hour time windows over 24 hours. The milk/plasma ratio, estimated daily infant dose, relative infant dose, and infant/maternal exposure ratio were calculated according to FDA guidance. Based on the concentration and safety data, ondansetron administered to breastfeeding mothers at doses of 4 mg/day is unlikely to result in clinically relevant exposures or adverse outcomes in breastmilk fed infants. The safety population included enrolled mothers (N=87) and infants (N=84).