Pregnancy & Lactation : הריון/הנקה

4.6     Fertility, pregnancy and lactation

Women of childbearing potential/Contraception in males and females
Women of childbearing potential and men receiving docetaxel should be advised to avoid becoming pregnant, and not to father a child and to inform the treating physician immediately should this occur.

Due to the genotoxic risk of docetaxel (see section 5.3), women of childbearing potential must use effective method of contraception during treatment and for 2 months after cessation of treatment with docetaxel. Men must use effective contraception during treatment and for 4 months after cessation of treatment with docetaxel.

Pregnancy

There is no information on the use of docetaxel in pregnant women. Docetaxel has been shown to be both embryotoxic and foetotoxic in rabbits and rats. As with other cytotoxic medicinal products, docetaxel may cause foetal harm when administered to pregnant women. Therefore, docetaxel must not be used during pregnancy unless clearly indicated.


Breast-feeding

Docetaxel is a lipophilic substance but it is not known whether it is excreted in human milk.
Consequently, because of the potential for adverse reactions in nursing infants, breast feeding must be discontinued for the duration of docetaxel therapy.

Fertility

Studies in animals have shown that docetaxel may alter male fertility (see section 5.3). Therefore, males being treated with docetaxel must seek advice on conservation of sperm prior to treatment.