Spevigo Use In Pregnancy & Lactation

Pregnancy: There are limited data from the use of spesolimab in pregnant women. Pre-clinical studies using a surrogate, mouse specific anti-IL36R monoclonal antibody do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Human immunoglobulin (IgG) is known to cross the placental barrier. As a precautionary measure, it is recommended to avoid the use of SPEVIGO in pregnancy, unless the expected clinical benefit clearly outweighs the potential risks.
Breast-feeding: It is unknown whether spesolimab is excreted in human milk. There are no data on the effects on the breastfed infant, or the effects on milk production. Spesolimab is a monoclonal antibody and is expected to be present in human milk. A risk to newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to abstain from SPEVIGO therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility: There are no data available on the effect of spesolimab on human fertility. Pre-clinical studies in mice using a surrogate, mouse specific anti-IL36R monoclonal antibody, do not indicate direct or indirect harmful effects with respect to fertility from antagonism of IL36R.