Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Women of childbearing potential

Patients who have Gaucher disease and become pregnant may experience a period of increased disease activity during pregnancy and the puerperium. A risk-benefit assessment is required for women with Gaucher disease who are considering pregnancy.

Pregnancy
There are no or limited amount of data from the use of velaglucerase alfa in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Close monitoring of the pregnancy and clinical manifestations of Gaucher disease is necessary for the individualisation of therapy. Caution should be exercised when prescribing to pregnant women.

Breast-feeding

There is insufficient information on the excretion of velaglucerase alfa or its metabolites in human milk. Velaglucerase is a synthetic form of beta-glucocerebrosidase, which is a normal component of human milk. Studies with other forms of the enzyme have found very low levels of the enzyme in breastmilk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from VPRIV taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility

Animal studies show no evidence of impaired fertility (see section 5.3).