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Pregnancy: Risk Summary: There are no adequate data from the use of Fraizeron in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/fetal development, parturition or postnatal development. Because animal reproduction studies are not always predictive of human response, Fraizeron should be used during pregnancy only if the benefits clearly outweigh the potential risks.
Animal Data: In an embryofetal development study in cynomolgus monkeys, secukinumab showed no maternal toxicity, embryotoxicity or teratogenicity when administered throughout organogenesis and late gestation.
No undesirable effects of an anti-murine IL-17A antibody were seen in a pre-and postnatal development study in mice. The high dose used in this study was in excess of the maximally effective dose in terms of IL-17A suppression and activity.
Lactation: It is not known whether secukinumab is excreted in human milk. Because immunoglobulins are excreted in human milk, caution should be exercised when Fraizeron is administered to a woman who is breast-feeding.
Females and males of reproductive potential: Infertility: There are no special recommendations for women of child-bearing potential.
The effect of Fraizeron on human fertility has not been evaluated. No undesirable effects of an anti-murine IL-17A antibody were seen in fertility and early embryonic development studies in mice. The high dose used in the study was in excess of the maximally effective dose in terms of IL-17A suppression and activity.
