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 Information 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.
Infant exposure in utero: For infants exposed in utero to ustekinumab, a six month waiting period following birth is recommended before the administration of live vaccines. Administration of a live vaccine prior to 6 months of age may be considered if ustekinumab dosing was limited to the first trimester of pregnancy when placental transport is minimal, or ustekinumab serum levels are undetectable in the infant, or the benefit of the vaccination clearly outweighs the theoretical risk of administration of live vaccines to the infant.
Breast-feeding: Limited data from published literature suggests that ustekinumab is excreted in human breast milk in very small amounts. While systemic exposure to a breastfed infant is expected to be low because ustekinumab is a large molecule and is degraded in the gastrointestinal tract, it is not known if Ustekinumab (Stelara) is absorbed systemically after ingestion. 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 Information under Actions).