Vyloy Use In Pregnancy & Lactation

Women of childbearing potential: As a precautionary measure, women of childbearing potential should be advised to use effective contraception to prevent pregnancy during treatment.
Pregnancy: There are no data on the use of zolbetuximab in pregnant women. No adverse effects were observed in an animal reproductive and developmental study with intravenous administration of zolbetuximab to pregnant mice during organogenesis (see Pharmacology: Toxicology: Preclinical safety data under Actions). Zolbetuximab should only be given to a pregnant woman if the benefit outweighs the potential risk.
Breast-feeding: There are no data on the presence of zolbetuximab in human milk, the effects on the breast-fed child, or the effects on milk production. Since it is known that antibodies can be excreted in human milk, and because of the potential for serious adverse reactions in a breast-fed child, breast-feeding is not recommended during treatment with zolbetuximab.
Fertility: Studies to evaluate the effect of zolbetuximab on fertility have not been performed. Thus, the effect of zolbetuximab on male and female fertility is unknown.