Pregnancy & Lactation : הריון/הנקה

4.6    Fertility, pregnancy and lactation
Contraception in males and females

Due to the genotoxic potential of hydroxycarbamide (see section 5.3), women of childbearing potential should use effective contraceptive measures while being treated with hydroxycarbamide and for 6 months following completion of treatment.
Men are recommended to use effective contraceptive measures and to not father a child while receiving hydroxycarbamide and for 3 months following completion of treatment.

Pregnancy
Hydroxycarbamide may be a potent mutagenic agent. Animal studies with hydroxycarbamide indicated an increased incidence of congenital defects (see section 5.3). Hydroxyurea medac should not be used during pregnancy unless the clinical condition of the woman requires treatment with hydroxycarbamide.
If pregnancy still occurs during treatment the possibility of genetic consultation should be offered.
Hydroxycarbamide crosses the placenta.

Breast-feeding

Hydroxyurea medac is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from hydroxycarbamide, a decision should be made whether to discontinue nursing or to discontinue Hydroxyurea medac, taking into account the importance of the drug to the mother.

Fertility

Hydroxycarbamide may be genotoxic, therefore, genetic consultation is recommended if a patient intends to have children after therapy with hydroxycarbamide.
Men should be informed about the possibility of sperm conservation before the start of therapy.
Fertility in males might be affected by treatment. Reversible oligo- and azoospermia are very commonly observed.