Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Contraception
Due to the potential for genotoxicity, advise female patients of reproductive potential to use highly effective contraception during treatment and for 6 months after the last dose of irinotecan (see section 4.4).
Due to the potential for genotoxicity, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of irinotecan (see section 4.4).

Pregnancy
There are limited data from the use of irinotecan in pregnant women. Irinotecan has been shown to be embryotoxic and teratogenic in animals (see section 5.3). Therefore, based on results from animal studies and the mechanism of action of irinotecan, irinotecan should not be used during pregnancy unless clearly necessary.
Women of childbearing potential should not be started on irinotecan until pregnancy is excluded. Pregnancy should be avoided if either partner is receiving irinotecan 
Breast-feeding
The available data are limited but suggested that irinotecan and its metabolite are excreted in human milk. Consequently, because of the potential for adverse reactions in nursing infants, breast-feeding should be discontinued for the duration of irinotecan therapy (see sections 4.3 and 4.4).

Fertility
There are no human data on the effect of irinotecan on fertility. In animals adverse effects of irinotecan on the fertility of offspring have been documented (see section 5.3). Prior to starting to take irinotecan consider advising patients on the preservation of gametes.