Women of childbearing potential: Pregnancy status of females of child-bearing potential should be verified prior to initiating treatment with lecanemab.
Women of childbearing potential should use effective contraception during treatment and for 2 months after the last dose of lecanemab.
Pregnancy: There are no data on the use of lecanemab in pregnant women or animal data to assess the risk of lecanemab during pregnancy. Human IgG is known to cross the placenta after the first trimester of pregnancy. Therefore, lecanemab has the potential to be transmitted from the mother to the developing foetus. The effects of lecanemab on the developing foetus are unknown. Lecanemab is not recommended during pregnancy.
Breast-feeding: There are no data on the presence of lecanemab in human milk, the effects on the breast-fed infants, or the effects of the drugs on milk production.
Human IgG is known to be excreted in breast milk during the first days after birth, which is decreasing to low concentrations soon afterwards. The effects of this exposure to breastfed infant are unknown and a risk cannot be excluded. Therefore, a decision should be made whether to discontinue breast-feeding or to discontinue lecanemab, taking into account the benefit of breast-feeding for the child and the benefit of lecanemab therapy for the woman.
Fertility: There are no data on the effects of lecanemab on human fertility.
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