Ustekinumab-Aauz

Contraindications

4 CONTRAINDICATIONS OTULFI is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in OTULFI [see Warnings and Precautions ( 5.5 )]. Clinically significant hypersensitivity to ustekinumab products or to any of the excipients in OTULFI. ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary Available data from the Organization of Teratology Information Specialists (OTIS)/MotherToBaby Pregnancy Registry, published literature and pharmacovigilance in pregnant women have not identified a ustekinumab associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes ( see Data ). There are risks to the mother and the fetus associated with inflammatory bowel disease (IBD) in pregnancy . In animal reproductive and developmental toxicity studies, no adverse developmental effects were observed in offspring after administration of ustekinumab to pregnant monkeys at exposures greater than 100 times the maximum recommended human dose (MRHD). All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage of clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.