Stelara Use In Pregnancy & Lactation

Pregnancy: There is no evidence from animal studies of teratogenicity, birth defects or developmental delays at exposures up to approximately 150-fold higher compared to C_max following 4 weekly 90 mg subcutaneous injections or up to 21-fold higher compared to serum concentrations 1h following 6 mg/kg IV administration (see Pharmacology: Toxicology: Non-Clinical Studies under Actions). However, animal reproductive and developmental studies are not always predictive of human response.
It is not known whether Ustekinumab (Stelara) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Ustekinumab (Stelara) should be given to a pregnant woman only if the benefit clearly outweighs the risk.
Breast-feeding: Ustekinumab (Stelara) is excreted in the milk of lactating monkeys administered Ustekinumab (Stelara). It is not known if Ustekinumab (Stelara) is absorbed systemically after ingestion. Because many drugs and immunoglobulins are excreted in human milk, and because of the potential for adverse reactions in nursing infants from Ustekinumab (Stelara), a decision should be made whether to discontinue nursing or to discontinue the drug.
Fertility: The effect of Ustekinumab (Stelara) on human fertility has not been evaluated. No adverse effects on female fertility parameters were identified in a female fertility toxicity study conducted in mice (see Pharmacology: Toxicology: Non-Clinical Studies under Actions).