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, procedures, or storage conditions that deviate from product labeling and are not approved by the regulatory agencies.
• Please refer to the full Prescribing Information and Instructions for Use for INLEXZO for information regarding HOW SUPPLIED, STORAGE, and HANDLING.² 
  • INLEXZO is a hazardous drug. Follow applicable special handling and disposal procedures while handling INLEXZO and during the insertion and removal procedure.

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 16 How Supplied/Storage and Handling² 

How Supplied

• INLEXZO (gemcitabine intravesical system) contains 225 mg gemcitabine.
• INLEXZO (NDC# 57894-225-01) is available in a carton containing:
  • One sterile single-dose of INLEXZO in two clear laminate sleeves and packaged in an inner pouch. The inner pouch and a desiccant are packaged in an outer foil pouch. The outside surfaces of the inner and outer pouches are not sterile.
  • One sterile urinary catheter and one sterile stylet packaged together in a pouch.

Storage

• Store in the original package at 20°C to 25°C (68°F to 77°F); with excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Handling

• INLEXZO is a hazardous drug. Follow applicable special handling and disposal procedures.

Section 2 Dosage and Administration² 

• 2.3 Preparation and Intravesical Administration
• See the Instructions for Use enclosed in the carton for complete information on preparation, intravesical administration, and removal of INLEXZO.
• INLEXZO is a hazardous drug. Follow applicable special handling and disposal procedures while handling INLEXZO and during the insertion and removal procedure.
• During indwelling period of approximately 3 weeks, advise patients to avoid urine contact with skin, to void urine sitting on a toilet, to wash hands with soap and water and to wash their genital area with water after each urination, and to flush the toilet after use.

Select Instructions for Use³ 

• INLEXZO is a hazardous drug. Follow applicable special handling and disposal procedures while handling INLEXZO and during the insertion and removal procedure. Dispose of the used urinary catheter and stylet, INLEXZO, and its packaging per facility procedures and per applicable federal, state, and local regulations.
• 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.
• If contact with INLEXZO is suspected, immediately wash the skin thoroughly or rinse the mucosa with copious amounts of water.
• Advise patients and caregivers to exercise caution when handling urine during indwelling period of approximately 3 weeks. See INLEXZO PI for details.

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 21 August 2025.