Summary

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• Please refer to the local labeling for relevant information regarding use of ICOTYDE in pregnancy.

PRESCRIBING INFORMATION

Use in Specific Populations - Pregnancy

Risk Summary¹  

• The available data on the use of ICOTYDE during pregnancy are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
• The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, and other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
• There is a pregnancy safety study for ICOTYDE. If a patient becomes pregnant while receiving ICOTYDE, healthcare providers can report ICOTYDE exposure by calling 1-800-526-7736 or visiting www.ICOTYDE.com.

Animal Data¹  

• In an embryo-fetal development study, icotrokinra was administered to pregnant rats during the period of organogenesis at oral doses of 70, 200, and 1000 mg/kg/day. No maternal or embryo-fetal toxicity was observed at doses up to 1000 mg/kg/day (297 times the maximum recommended human dose [MRHD] based on area under the curve [AUC] comparison).
• In another embryo-fetal development study, icotrokinra was administered to pregnant rabbits during the period of organogenesis at oral doses of 50, 200, and 500 mg/kg/day. Maternal body weight loss, low food consumption, late pregnancy loss, and an increased fetal incidence of fused ribs were observed at 500 mg/kg/day (157 times the MRHD based on AUC comparison). No maternal or embryo-fetal toxicity was noted at doses up to 200 mg/kg/day in rabbits (27 times the MRHD based on AUC comparison).
• In a pre- and post-natal development study in rats, icotrokinra was administered to pregnant rats during pregnancy and lactation periods at oral doses of 20, 70, and 200 mg/kg/day. No maternal or developmental toxicity was noted in doses up to 200 mg/kg/day (127 times the MRHD based on AUC comparison).

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 13 March 2026.