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 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 information regarding the disposal of INLEXZO.
  • INLEXZO is a hazardous drug. Follow applicable special handling and disposal procedures while handling INLEXZO and during the insertion and removal procedure.^2,3 

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 a hazardous drug. Follow applicable special handling and disposal procedures while handling INLEXZO and during the insertion and removal procedure.^2,3 
• Dispose of the used urinary catheter and stylet, INLEXZO, and its packaging per facility procedures and per applicable federal, state and local regulations.³ 
• Wear gloves, and take appropriate precautions, per local guidelines for handling hazardous drugs, to prevent skin or mucus membrane exposure while handling INLEXZO and during the insertion and removal procedure.³ 
• If contact with INLEXZO is suspected, immediately wash the skin thoroughly or rinse the mucosa with copious amounts of water.³ 
• Advise patients and caregivers to exercise caution when handling urine during indwelling period of approximately 3 weeks. See INLEXZO PI for details.³ 
• Do not use the urinary catheter and stylet for any other purpose. Do not re-sterilize/re-use the urinary catheter or stylet. Re-use of the urinary catheter and stylet can lead to its degradation, failure, and contamination, which can increase the risk of infection or transmission of blood borne pathogens to patients and users.³ 

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.