Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Women of childbearing potential / Contraception in males and females
Women should use effective contraceptives during treatment with Ilaris and for up to 3 months after the last dose.

Pregnancy
There is a limited amount of data from the use of canakinumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). The risk for the fetus/mother is unknown. Women who are pregnant or who desire to become pregnant should therefore only be treated after a thorough benefit-risk evaluation.
Animal studies indicate that canakinumab crosses the placenta and is detectable in the foetus. No human data are available, but as canakinumab is an immunoglobulin of the G class (IgG1), human transplacental transfer is expected. The clinical impact of this is unknown. However, administration of live vaccines to newborn infants exposed to canakinumab in utero is not recommended for 16 weeks following the mother’s last dose of Ilaris before childbirth. Women who received canakinumab during pregnancy should be instructed to inform the baby’s healthcare professional before any vaccinations are given to their newborn infant.

Breast-feeding
It is unknown whether canakinumab is excreted in human milk. The decision whether to breast-feed during Ilaris therapy should therefore only be taken after a thorough benefit-risk evaluation.

Animal studies have shown that a murine anti-murine IL-1 beta antibody had no undesirable effects on development in nursing mouse pups and that the antibody was transferred to them (see section 5.3).

Fertility
Formal studies of the potential effect of Ilaris on human fertility have not been conducted.
Canakinumab had no effect on male fertility parameters in marmosets (C. jacchus). A murine anti-murine IL-1beta antibody had no undesirable effects on fertility in male or female mice (see section 5.3).