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INLEXZO™

(gemcitabine intravesical system)

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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

INLEXZO™ (gemcitabine intravesical system)

Medical Information

Clinical Practice Guidelines

Last Updated: 10/23/2025

summary

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)

  • NCCN Guidelines® for Bladder Cancer recommends gemcitabine intravesical system (INLEXZO) as a therapy option in Bacillus Calmette-Guérin (BCG)-unresponsive or BCG-intolerant high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS; with or without papillary) tumors (NCCN Category 2A).1
  • National Comprehensive Cancer Network® (NCCN®) Categories of Evidence define Category 2A as based upon lower-level evidence, and there is uniform NCCN consensus (≥85% support of the Panel) that the intervention is appropriate.1
  • Please refer to the NCCN Guidelines for Bladder Cancer at www.nccn.org for current and complete recommendations for the use of gemcitabine intravesical system (INLEXZO).1 
  • Please refer to the full Prescribing Information for INLEXZO (gemcitabine intravesical system) for information on INDICATIONS & USAGE.2,3 

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References

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1 Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Bladder Cancer V.2.2025. ©National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed October 15, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.  
2 INLEXZO (gemcitabine intravesical system) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/INLEXZO-pi.pdf
3 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