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 STORAGE.^2,3 
  • INLEXZO is a hazardous drug (HD). Follow applicable special handling and disposal procedures while handling INLEXZO and during the insertion and removal procedure.^2,3 
  • 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].² 
• INLEXZO is in its final dosage form and does not require further manipulation other than removal from its original packaging.
  • Final dosage forms of antineoplastic HDs may be stored with other inventory if permitted by entity policy.⁴ 
  • Antineoplastic HDs requiring manipulation other than counting or repackaging of final dosage forms and any HD active pharmaceutical ingredient (API) must be stored separately from non-HDs in a manner that prevents contamination and personnel exposure. These antineoplastic HDs requiring manipulation other than counting or repackaging of final dosage forms and any API must be stored in an externally ventilated, negative-pressure room with at least 12 air changes per hour (ACPH).⁴ 

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 06 November 2025.