SUMMARY

• INLEXZO (gemcitabine intravesical system) is an intravesical drug releasing system (iDRS), referred to as TAR-200 in literature.¹ 
• Johnson & Johnson cannot recommend any practices or procedures that deviate from product labeling and are not approved by the regulatory agencies.
• Please refer to the full prescribing information of INLEXZO for CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS in patients with perforation of the bladder.² 
  • INLEXZO is contraindicated in patients with perforation of the bladder [see Warnings and Precautions (5.1)].
• SunRISe-1 (NCT04640623) is an ongoing, phase 2b, randomized, open-label, multicenter study evaluating the efficacy and safety of intravesical INLEXZO plus systemic cetrelimab, an investigational immunoglobulin G4 (IgG4) antibody that targets the programmed cell death protein-1 (PD-1) receptor (cohort 1), INLEXZO alone (cohort 2), or cetrelimab alone (cohort 3) in patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk, non-muscle invasive bladder cancer (NMIBC) who are ineligible for or decline radical cystectomy (RC). INLEXZO alone is additionally being studied in patients with papillary-only BCG-unresponsive HR-NMIBC (no CIS; cohort 4).^1,3,4 
  • Any potential participant who had evidence of bladder perforation during the diagnostic cystoscopy was excluded from participating in the study.⁴   

PRODUCT LABELING

• INLEXZO (gemcitabine intravesical system) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/INLEXZO-pi.pdf.
• INLEXZO (gemcitabine intravesical system) [Instructions for Use]. Horsham, PA: Janssen Biotech, Inc; https://www.janssenlabels.com/package-insert/product-instructions-for-use/INLEXZO-ifu.pdf.

Section 4 Contraindications² 

• INLEXZO is contraindicated in patients with perforation of the bladder [see Warnings and Precautions (5.1)]. 

Section 5 Warnings and Precautions² 

5.1 Risks in Patients with Perforated Bladder

• INLEXZO may lead to systemic exposure to gemcitabine and to severe adverse reactions if administered to patients with a perforated bladder or to those in whom the integrity of the bladder mucosa has been compromised. 
• Evaluate the bladder before the intravesical administration of INLEXZO and do not administer to patients with a perforated bladder or mucosal compromise until bladder integrity has been restored [see Contraindications (4)]. 

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 22 August 2025.

Summarized in this response are relevant data limited to INLEXZO monotherapy (cohort 2) of the phase 2b SunRISe-1 study in patients with BCG-unresponsive NMIBC with CIS with or without papillary tumors.