Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Women of childbearing potential/Contraception in males and females
Women of childbearing potential have to use effective contraception during treatment and for 6 months after the last dose.
Male patients with female partners of childbearing potential have to use effective contraception during treatment with sacituzumab govitecan and for 3 months after the last dose.

Pregnancy

There are no available data on the use of sacituzumab govitecan in pregnant women. However, based on its mechanism of action, sacituzumab govitecan can cause teratogenicity and/or embryo-foetal lethality when administered during pregnancy. Sacituzumab govitecan contains a genotoxic component, SN-38, and targets rapidly dividing cells.
Sacituzumab govitecan should not be used during pregnancy unless the clinical condition of the woman requires treatment with sacituzumab govitecan.
The pregnancy status of women of childbearing potential should be verified prior to the initiation of sacituzumab govitecan.
Women who become pregnant must immediately contact their doctor.
Breast-feeding

It is unknown whether sacituzumab govitecan or its metabolites are excreted in human milk. A risk to breastfed newborns/infants cannot be excluded. Breast-feeding should be discontinued during treatment with sacituzumab govitecan and for 1 month after the last dose.

Fertility

Based on findings in animals, sacituzumab govitecan may impair fertility in females of reproductive potential (see section 5.3). No human data on the effect of sacituzumab govitecan on fertility are available.