Pexidartinib and Pregnancy

In this article, we will discuss Pexidartinib and Pregnancy. So, let’s get started.

Pexidartinib and Pregnancy

Based on findings from animal studies and its mechanism of action, Pexidartinib may cause embryo-fetal harm when administered to a pregnant woman. The available human data do not establish the presence or absence of major birth defects or miscarriage related to the use of Pexidartinib. Oral administration of pexidartinib to pregnant animals during the period of organogenesis resulted in malformations, post-implantation loss, and abortion at maternal exposures that were
approximately equal to the human exposure at the recommended dose of 800 mg. Advise pregnant women of the potential risk to a fetus.

In the U.S. general population, the estimated background risk of major birth defects and
miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

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