Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation
Women of childbearing potential
Women of childbearing potential must use effective contraception during and up to 3 months after treatment (see section 4.5).

Pregnancy
There are no data from the use of siltuximab in pregnant women. Studies in animals with siltuximab have shown no adverse effect on pregnancy or on embryofetal development (see section 5.3).
Siltuximab is not recommended during pregnancy and in women of childbearing potential not using contraception.

Siltuximab should be given to a pregnant woman only if the benefit clearly outweighs the risk.

As with other immunoglobulin G antibodies, siltuximab crosses the placenta as observed in studies in monkeys. Consequently, infants born to women treated with siltuximab may be at increased risk of infection, and caution is advised in the administration of live vaccines to these infants (see section 4.4).

Breast-feeding
It is unknown whether siltuximab is excreted in human milk.
A risk to the newborns/infants cannot be excluded.
A decision must be made whether to discontinue breast-feeding or discontinue/abstain from siltuximab therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility
Effects of siltuximab on fertility have not been evaluated in humans. Available non-clinical data do not suggest an effect on fertility under siltuximab treatment (see section 5.3).