Xospata Use In Pregnancy & Lactation

Pregnancy: Gilteritinib can cause fetal harm based upon findings from animal studies. Xospata showed suppressed fetal growth, embryo-fetal deaths and teratogenicity in the embryo-fetal development studies in rats. Advise pregnant women of the potential risk to a fetus (see PHARMACOLOGY: Toxicology: Preclinical safety data under Actions).
Breast-feeding: There is no information regarding the presence of Xospata in human milk, the effects on the breastfed infant, or the effects on milk production. In animal studies, gilteritinib and/or its metabolite(s) were distributed to the tissues in infant rats via the milk. Breastfeeding is not recommended during Xospata treatment and for at least 2 months after the last dose (see PHARMACOLOGY: Toxicology: Preclinical safety data under Actions).
Fertility: Pregnancy testing: Pregnancy testing is recommended for females of reproductive potential within seven days prior to initiating Xospata treatment (see PHARMACOLOGY: Toxicology: Preclinical safety data under Actions).
Contraception: Advise females of reproductive potential to use effective contraception during treatment and for at least 6 months after the last dose of Xospata (see PHARMACOLOGY: Toxicology: Preclinical safety data under Actions).
Advise males of reproductive potential to use effective contraception during treatment and for at least 4 months after the last dose of Xospata.