Pregnancy & Lactation : הריון/הנקה

4.6         Fertility, pregnancy and lactation

Pregnancy
Veoza is contraindicated during pregnancy (see section 4.3). If pregnancy occurs during use with Veoza, treatment should be withdrawn immediately.

There are no or limited data from the use of fezolinetant in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Perimenopausal women of childbearing potential should use effective contraception. Non-hormonal contraceptives are recommended for this population.

Breast-feeding

Veoza is not indicated during lactation.
It is unknown whether fezolinetant and its metabolites are excreted in human milk. Available pharmacokinetic data in animals showed excretion of fezolinetant and/or its metabolites in animal milk (see section 5.3). A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Veoza therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility

There are no data on the effect of fezolinetant on human fertility. In the fertility study in female rats, fezolinetant did not affect fertility (see section 5.3).