Pregnancy: There are no data from the use of Praluent in pregnant women. Alirocumab is a recombinant IgG1 antibody, therefore it is expected to cross the placental barrier (see Pharmacology: Toxicology: Preclinical safety data under Actions). Animal studies do not indicate direct or indirect harmful effects with respect to maintenance of pregnancy or embryo-fetal development; maternal toxicity was noted in rats, but not in monkeys at doses in excess of the human dose, and a weaker secondary immune response to antigen challenge was observed in the offspring of monkeys (see Pharmacology: Toxicology: Preclinical safety data under Actions). The use of Praluent is not recommended during pregnancy unless the clinical condition of the woman requires treatment with alirocumab.
Breast-feeding: It is not known whether alirocumab is excreted in human milk. Human immunoglobulin G (IgG) is excreted in human milk, in particular in colostrum; the use of Praluent is not recommended in breast-feeding women during this period. For the remaining duration of breast-feeding, exposure is expected to be low. Since the effects of alirocumab on the breast-fed infant are unknown, a decision should be made whether to discontinue nursing or to discontinue Praluent during this period.
Fertility: In animal studies, there were no adverse effects on surrogate markers of fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions). There are no data on adverse effects on fertility in humans.