Pregnancy & Lactation : הריון/הנקה

4.6      Fertility, pregnancy and lactation
When administered intramuscularly to rats on days 6-15 of pregnancy at doses of 0.4, 1.6 and 6.4 mcg/kg/day (0.6, 2.5 and 10.0 times the intranasal human dose of 400mcg per day), 4/80 foetuses in the highest dose group had major foetal abnormalities that were not seen in a repeat study in rats. Moreover, studies in mice and rabbits failed to demonstrate an increase in foetal abnormalities. In rats, there was a dose-related increase in foetal mortality, and a decrease in foetal weight with the highest dose. These effects on rat foetal mortality are logical consequences of the alterations in hormonal levels brought about by nafarelin in this species.


               Use of nafarelin in human pregnancy has not been studied.
Synarel® should not therefore be used during pregnancy or suspected pregnancy. Before starting treatment with Synarel®, pregnancy must be excluded. If a patient becomes pregnant during treatment, administration of the drug must be discontinued and the patient must be informed of a potential risk to foetal development. (see Section 4.3).

Controlled ovarian stimulation prior to in vitro fertilisation: Pregnancy should be excluded before starting treatment with Synarel®, and the medication should be stopped on the day of administration of hCG. Barrier methods of contraception should be employed whilst Synarel® is being taken.

It is not known whether or to what extent nafarelin is excreted into human breast milk. The effects, if any on the breast-fed child have not been determined and therefore Synarel® should not be used by breast-feeding women. (see Section 4.3).