Gilteritinib Fumarate

Pregnancy

Gilteritinib can cause fetal harm when it is given to a pregnant woman. This comes from animal studies and from how the medicine works. There are no data on Gilteritinib use in pregnant women, so a drug-associated risk of adverse developmental outcomes can't be worked out. In animal reproduction studies, pregnant rats given the medicine during organogenesis had embryo-fetal lethality, suppressed fetal growth and teratogenicity. This happened at maternal exposures (AUC24) of about 0.4 times the AUC24 in patients receiving the recommended dose. Pregnant women should be told about the potential risk to the fetus. Adverse outcomes in pregnancy occur regardless of the mother's health or whether she uses medicines. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk in clinically recognised pregnancies is 2%-4% for major birth defects and 15%-20% for miscarriage.

Lactation

There are no data on whether Gilteritinib and/or its metabolites pass into human milk, what effect they have on a breastfed child, or what effect they have on milk production. When radiolabeled Gilteritinib was given to lactating rats, the radioactivity in the milk was higher than in the mother's plasma at 4 and 24 hours after the dose. In animal studies, Gilteritinib and/or its metabolite(s) reached the tissues of infant rats through the milk. Because a breastfed child could have serious adverse reactions, a lactating woman should be advised not to breastfeed during treatment and for at least 2 months after the last dose.