Ilumetri Use In Pregnancy & Lactation

Women of childbearing potential: Women of childbearing potential should use an effective method of contraception during treatment and for at least 17 weeks after treatment.
Pregnancy: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of tildrakizumab in pregnant women. Animal studies do not indicate direct or indirect harmful effect with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). As a precautionary measure, it is preferable to avoid the use of Ilumetri during pregnancy.
Breast-feeding: It is unknown whether tildrakizumab is excreted in human milk. Available toxicological data in cynomolgus monkey have shown negligible levels of Ilumetri in milk on postnatal day 28 (see Pharmacology: Toxicology: Preclinical safety data under Actions). In humans, during the first few days after birth antibodies may be transferred to the newborns through milk. In this short period, a risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Ilumetri therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: The effect of Ilumetri on human fertility has not been evaluated. Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).