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 should use effective methods of contraception during treatment. For women and men the contraception should be continued for at least 6 months after cessation of treatment with Cardioxane (see section 4.4).


Pregnancy
There are no adequate data from the use of dexrazoxane in pregnant women. Animal studies showed embryotoxic and teratogenic effects (see section 5.3). The potential risk for humans is unknown. Cardioxane is used with anthracyclines known to have cytotoxic, mutagenic and embryotoxic properties. Cardioxane should not be used during pregnancy unless clearly necessary.

Breast-feeding
There are no animal studies on the transfer of the active substance and/or its metabolites into milk. It is unknown whether dexrazoxane and/or its metabolites are excreted in human milk. Because of the potential for serious adverse reactions in infants exposed to Cardioxane, breast-feeding is contraindicated during Cardioxane treatment (see section 4.3).

Fertility
The effect of Cardioxane on the fertility of humans has not been studied.
There are limited fertility data from animal studies available, but testicular changes were observed in rats and dogs following repeat dosing (see Section 5.3).