Pregnancy: Risk Summary: There are no adequate data from the use of Cosentyx 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, Cosentyx 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.
Lactation: It is not known whether secukinumab is excreted in human milk. Because immunoglobulins are excreted in human milk, caution should be exercised when Cosentyx is administered to a woman who is breast-feeding.
Females and males of reproductive potential: Infertility: There are no special recommendations for females of reproductive potential.
The effect of Cosentyx on human fertility has not been evaluated. Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see Pharmacology: Toxicology: NON-CLINICAL SAFETY DATA under Actions).