Tremfya Use In Pregnancy & Lactation

Pregnancy: The use of Guselkumab (Tremfya) in pregnant women has not been studied. The effect of Guselkumab (Tremfya) on human pregnancy is unknown. No maternal, embryo or fetal toxicity was observed in cynomolgus monkeys after administration of guselkumab. As with other IgG antibodies, guselkumab crosses the placenta and was detectable in newborn cynomolgus monkey serum samples indicating transplacental transfer of drug (see Pharmacology: Toxicology: Non-Clinical Information under Actions).
Guselkumab (Tremfya) should be used during pregnancy only if clearly needed.
Breast-feeding: There are no data on the presence of guselkumab in human milk, the effects on the breastfed infant, or the effects on milk production. Guselkumab was not detected in the milk of lactating cynomolgus monkeys (see Pharmacology: Toxicology: Non-Clinical Information under Actions). The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Guselkumab (Tremfya).
Fertility: The effect of Guselkumab (Tremfya) on human fertility has not been evaluated. No guselkumab-related effects on fertility parameters were identified in female and male fertility studies conducted in guinea pigs (see Pharmacology: Toxicology: Non-Clinical Information under Actions).