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The U.S. Food and Drug Administration (FDA) initiated this study in the Sentinel System to examine the potential exposure of pregnant women to ibrexafungerp. Ibrexafungerp, a first-in-class agent of a new antifungal class (triterpenoid), is approved for treatment of vulvovaginal candidiasis and for reduction in the incidence of recurrent vulvovaginal candidiasis in adult and post-menarchal pediatric females. Ibrexafungerp is contraindicated during pregnancy due to potential fetal harm, based on findings from animal reproductive studies. However, most ibrexafungerp users are expected to be women of reproductive age. This Sentinel study aimed to actively monitor postmarket exposure to ibrexafungerp during pregnancy.
Between June 1, 2021, and August 31, 2023, results indicated that out of 385,507 eligible pregnancy episodes, three pregnancies were potentially exposed to ibrexafungerp during the first trimester when assuming a 7-day supply. When a 30-day supply was assumed, seven pregnancies were potentially exposed during the first trimester. However, these exposures cannot be definitively confirmed due to known limitations of the rapid Sentinel database. Some database limitations include not having confirmation of whether the patient consumed the drug and the algorithms used may have misclassified pregnancy start and duration. This study supported the enhanced monitoring of ibrexafungerp utilization to identify any potential exposure to ibrexafungerp during pregnancy.