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 6mg/kg IV administration (see Pharmacology: Toxicology: Non-Clinical Information under Actions). However, animal reproductive and developmental studies are not always predictive of human response.
Data from prospectively collected pregnancies following exposure to STELARA resulting in live birth with known outcomes, including more than 450 pregnancies exposed during the first trimester, do not indicate an increased risk of malformations in the newborn.
Overall, data from observational studies, pharmacovigilance, and published case reports and cohort studies do not indicate an increase in the risk of major birth defects, pattern of major or minor anomalies, miscarriage, or adverse infant outcomes.
STELARA should be given to a pregnant woman if the benefit clearly outweighs the risk.
Breast-feeding: Limited data from published literature suggests that ustekinumab is excreted in human breast milk in very small amounts. It is not known if ustekinumab is absorbed systemically after ingestion. Because of the potential for adverse reactions in nursing infants from ustekinumab, a decision on whether to discontinue breast-feeding during treatment and up to 15 weeks after treatment or to discontinue therapy with STELARA must be made taking into account the benefit of breast-feeding to the child and the benefit of STELARA therapy to the woman.
Fertility: The effect of 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).
It is not known whether STELARA can affect reproductive potential.