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 and Instructions for Use of INLEXZO for proper preparation and intravesical administration of INLEXZO.^2,3 
  • Administer INLEXZO intravesically only. Do NOT administer by any other route. INLEXZO is co-packaged with a urinary catheter and stylet used to insert INLEXZO through the urinary catheter into the bladder. Administer using the co-packaged urinary catheter and stylet only.
  • INLEXZO should be inserted and removed by a trained healthcare provider. Healthcare providers should become thoroughly familiar with the insertion and removal instructions before attempting insertion or removal of INLEXZO. 
  • Prophylactic antibiotics may be used at the discretion of the treating healthcare provider with each INLEXZO insertion and removal.
  • See the Instructions for Use enclosed in the carton for complete information on preparation and intravesical administration. 
• SunRISe-1 (NCT04640623) (NCT04640623) is an ongoing, phase 2b, randomized, open-label, parallel-cohort, multicenter study evaluating the efficacy and safety of intravesical INLEXZO plus cetrelimab (investigational immunoglobulin G4 [IgG4] antibody targeting programmed cell death protein-1 [PD-1] receptor; cohort 1), INLEXZO monotherapy (cohort 2), or cetrelimab monotherapy (cohort 3) in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary disease who are ineligible for or decline radical cystectomy (RC). INLEXZO monotherapy is additionally being studied in patients with BCG-unresponsive papillary-only high-risk NMIBC (no CIS; cohort 4).^1,4  
  • Patients were excluded from the study in the presence of any bladder or urethral anatomic feature (eg, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of INLEXZO, or passage of a urethral catheter for intravesical chemotherapy, or administration of intravesical BCG. Patient with tumors involving the prostatic urethra in men were excluded.⁵ 
  • Additionally, indwelling catheters were not permitted; however, intermittent catheterization was acceptable.⁵ 

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.

Literature Search

A literature search of MEDLINE^®, Embase, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 18 August 2025.