Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Pregnancy
FIRDAPSE should not be used during pregnancy. Women of childbearing potential must use effective contraception during FIRDAPSE treatment. No adequate clinical data on exposed pregnancies are available for amifampridine. Amifampridine has shown no effect on embryo-foetal viability and development in rabbits; however, in rats, an increase in the number of mothers delivering still-born offspring was observed (see section 5.3).

Breast-feeding

It is unknown whether amifampridine is excreted in human breast milk. Available reproductive data in animals have shown presence of amifampridine in milk of breast-feeding mothers. Assessment of breast-feeding neo-natal animals showed no indication of adverse reactions when exposed to amifampridine through breast-milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from FIRDAPSE therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.



Fertility

Non-clinical safety data are available regarding the effects of amifampridine on reproductive function.
No impairment of fertility has been observed in non-clinical studies with amifampridine (see section 5.3).