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 during lactation or breastfeeding.

COMPANY CORE DATA SHEET

Breastfeeding

• There are no data on the presence of icotrokinra in human milk, the effects on the breastfed infant, or the effects on milk production.¹ 
• The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ICOTYDE and any potential adverse effects on the breastfed infant from ICOTYDE or from the underlying maternal condition.¹ 

Animal Data

• In a pre- and post-natal development study in rats, oral administration of icotrokinra during gestation (day 6) through lactation (day 20) did not cause adverse effects in offspring when given up to 200 mg/kg/day (127 times the maximum recommended human dose based on area-under-the-curve comparison).¹ 
• Available pharmacokinetic data in rats has shown icotrokinra to be present in the plasma of nursing pups. No developmental effects were observed on the nursing pups.¹ 

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 16 March 2026.