Pregnancy & Lactation : הריון/הנקה

4.6     Fertility, pregnancy and lactation

Pregnancy

There are no available data on sutimlimab from the use in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

Human IgG antibodies are known to cross the placental barrier; therefore, sutimlimab may be transmitted from the mother to the developing fetus.
As a precautionary measure, it is preferable to avoid the use of sutimlimab during pregnancy.
Sutimlimab should be given during pregnancy only if clearly indicated.

Breast-feeding

Human IgGs are known to be excreted in breast milk during the first few days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to the breast-fed infant cannot be excluded during this short period. It is unknown whether sutimlimab/metabolites are excreted in human milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from sutimlimab therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.

Fertility

Effects of sutimlimab on male and female fertility have not been studied in animals. In repeat-dose studies with sutimlimab with exposures at up to approximately 4 times the recommended human dose, no effects on reproductive organs were observed in cynomolgus monkeys.