Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Women of childbearing potential/contraception in males and females
Both sexually active men and women of childbearing potential should use effective methods of contraception during treatment.

Pregnancy
Based on human experience, dasatinib is suspected to cause congenital malformations including neural tube defects, and harmful pharmacological effects on the foetus when administered during pregnancy.
Studies in animals have shown reproductive toxicity (see section 5.3).
SPRYCEL should not be used during pregnancy unless the clinical condition of the woman requires treatment with dasatinib. If SPRYCEL is used during pregnancy, the patient must be informed of the potential risk to the foetus.

Breast-feeding
There is insufficient/limited information on the excretion of dasatinib in human or animal breast milk.
Physico-chemical and available pharmacodynamic/toxicological data on dasatinib point to excretion in breast milk and a risk to the suckling child cannot be excluded.
Breast-feeding should be stopped during treatment with SPRYCEL.

Fertility
In animal studies, the fertility of male and female rats was not affected by treatment with dasatinib (see section 5.3). Physicians and other healthcare providers should counsel male patients of appropriate age about possible effects of SPRYCEL on fertility, and this counseling may include consideration of semen deposition.