SUMMARY  

• Please refer to the local labeling for relevant fertility-related information for TREMFYA.
• The effect of TREMFYA on human fertility has not been evaluated.¹
• A limited amount of data is available from TREMFYA clinical studies in patients with psoriasis (PsO) or psoriatic arthritis (PsA) regarding paternal exposure with pregnancy outcomes.²

company core data sheet

CLINICAL INFORMATION

Pregnancy, Breast-feeding and Fertility

Fertility

The effect of TREMFYA on human fertility has not been evaluated. No guselkumab-related effects on fertility parameters were identified in female and male fertility studies conducted in guinea pigs.¹

Non-Clinical Information

Fertility

No effects on fertility parameters were identified in female and male fertility studies conducted in guinea pigs. Exposures (AUC) at the 100 mg/kg twice-weekly no-observed-adverse-effect-level (NOAEL) dose were at least 21-fold higher than those following administration of a 200 mg subcutaneous dose.¹

Clinical Data

Pooled Safety Analysis

In a pooled safety analysis of ongoing and completed TREMFYA clinical studies in patients with PsO or PsA, a total of 32 partner pregnancies were reported as of 12 July 2020 (Table: Paternal Cases: Pregnancy Outcomes in Patients Treated with TREMFYA).²

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 09 July 2024.