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 the dosing schedule of INLEXZO.²  
• In the SunRISe-1 study (NCT04640623), INLEXZO was available as one dose only. Dose modifications were not permitted due to the nature of INLEXZO, except for early removal (ie, to manage adverse events [AEs]), delayed placement (ie, a missed dosing cycle), or discontinuation of INLEXZO.^1,3,4  
• There is no data from clinical trials to support an indwelling period longer than 3 weeks for INLEXZO.

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.
• INLEXZO is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.² 
• Insert INLEXZO (225 mg of gemcitabine) into the bladder once every 3 weeks for up to 6 months (8 doses), followed by once every 12 weeks for up to 18 months (6 doses), or until persistent or recurrent NMIBC, disease progression, or unacceptable toxicity.² 
• Remove INLEXZO after each 3-week indwelling period.² 
• Missed Dose: If a dose is missed, it should be administered as closely as possible to the original treatment schedule.² 

CLinical Data

SunRISe-1 (NCT04640623) is an ongoing study designed to assess 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 NMIBC with 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).^1,3 

• Patients received INLEXZO (indwelling) monotherapy every 3 weeks for the first 24 weeks (6 months) and then every 12 weeks through week 96 (year 2).¹ 
• INLEXZO was available in one dose only. Dose modifications were not permitted due to the nature of INLEXZO, except for early removal (ie, to manage AEs), delayed placement (ie, a missed dosing cycle), or discontinuation of INLEXZO.⁴  
  • Missed dosing cycles were not made up or rescheduled during the study.
  • If a dosing cycle was missed and if the patient was eligible for continued administration of INLEXZO at that time, the patient would undergo placement of INLEXZO at the next scheduled insertion time.
  • For example, if INLEXZO was removed early or not placed due AEs considered related to INLEXZO or the urinary catheter, the patient could potentially resume the study schedule at the next scheduled placement timepoint, assuming the patient no longer meets the patient stopping safety criteria at that time.
• There is no data from clinical trials to support an indwelling period longer than 3 weeks for INLEXZO.

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.