Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Fertility
Women of childbearing potential must be apprised of the potential hazard to the foetus.
Both sexually active men and women of childbearing potential must take effective contraceptive measures during and at least for 6 months after cessation of therapy (see section 4.4).

Pregnancy
Preclinical data in rats demonstrated a transfer of fludarabine and/or metabolites through the placenta. The results from intravenous embryotoxicity studies in rats and rabbits indicated an embyrolethal and teratogenic potential at the therapeutic doses (see section 5.3).
There are very limited data of fludarabine use in pregnant women in the first trimester.
Fludarabine should not be used during pregnancy unless clearly necessary (e.g. life- threatening situation, no alternative safer treatment available without compromising the therapeutic benefit, treatment cannot be avoided). Fludarabine has the potential to cause fetal harm. Prescribers may only consider the use of fludarabine, if the potential benefits justify the potential risks to the foetus.

Breast-feeding
It is not known whether this drug or its metabolites are excreted in human milk.
However, there is evidence from preclinical data that fludarabine phosphate and/or metabolites transfer from maternal blood to milk.
Because of the potential for serious adverse reactions to fludarabine in breast-fed infants, fludarabine is contraindicated in nursing mothers (see section 4.3).