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 patients with renal impairment.

PRESCRIBING INFORMATION

Use in Specific Populations – Renal Impairment

• Monitor for potential adverse reactions when ICOTYDE is used in patients with an estimated glomerular filtration rate (eGFR) <60 mL/min.¹ 

Pharmacokinetics

• Icotrokinra area under the curve (AUC) increased by 2.47-fold in patients with moderate (eGFR ≥30 to <60 mL/min, [calculated according to Chronic Kidney Disease Epidemiology Collaboration]) and 2.78-fold in severe (eGFR ≥15 to <30 mL/min) renal impairment.¹ 
• No clinically significant differences in the pharmacokinetics of icotrokinra were observed in patients with mild renal impairment (eGFR ≥60 to <90 mL/min) based on population pharmacokinetic analysis.¹ 

EXCLUSION CRITERIA IN PHASE 3 CLINICAL TRIALS

• The ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2 phase 3 clinical trials evaluated the efficacy and safety of oral ICOTYDE 200 mg once daily in patients with moderate to severe plaque psoriasis.^2-4 
  • Patients with a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal disturbances were excluded from these studies.

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.