Xospata Use In Pregnancy & Lactation

Women of childbearing potential / Contraception in males and females: Pregnancy testing is recommended for females of reproductive potential seven days prior to initiating Xospata treatment. Women of childbearing potential are recommended to use effective contraception (methods that result in less than 1% pregnancy rates) during and up to 6 months after treatment. It is unknown whether gilteritinib may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method of contraception. Males of reproductive potential should be advised to use effective contraception during treatment and for at least 4 months after the last dose of Xospata (see Precautions).
Pregnancy: Gilteritinib can cause foetal harm when administered to pregnant women. There are no or limited amount of data from the use of gilteritinib in pregnant women. Reproductive studies in rats have shown that gilteritinib caused suppressed foetal growth, embryo-foetal deaths and teratogenicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Xospata is not recommended during pregnancy and in women of childbearing potential not using effective contraception.
Breast-feeding: It is unknown whether gilteritinib or its metabolites are excreted in human milk. Available animal data have shown excretion of gilteritinib and its metabolites in the animal milk of lactating rats and distribution to the tissues in infant rats via the milk (see Pharmacology: Toxicology: Preclinical safety data under Actions).
A risk to breast-fed children cannot be excluded. Breast-feeding should be discontinued during treatment with Xospata and for at least two months after the last dose.
Fertility: There are no data on the effect of gilteritinib on human fertility.