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INLEXZO™ (gemcitabine intravesical system)
Medical Information
INLEXZO - Use in Pediatric Patients
Last Updated: 04/15/2026
SUMMARY
INLEXZO (gemcitabine intravesical system) is an intravesical drug releasing system (iDRS), referred to as gem-iDRS and TAR-200 in literature.1 - Johnson & Johnson does not recommend any practices, procedures or usage that deviate from the product labeling or are not approved by the regulatory agencies.
- 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
- Safety and effectiveness of INLEXZO in pediatric patients have not been established.2
Product labeling
- INLEXZO (gemcitabine intravesical system) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc; https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/INLEXZO-pi.pdf.
- INLEXZO (gemcitabine intravesical system) [Instructions for Use]. Horsham, PA: Janssen Biotech, Inc; https://www.jnjlabels.com/package-insert/product-instructions-for-use/INLEXZO-ifu.pdf.
Literature Search
A literature search of MEDLINE®
References
| 1 | Daneshmand S, van der Heijden MS, Jacob JM, et al. TAR-200 for Bacillus Calmette-Guérin–unresponsive high-risk non–muscle-invasive bladder cancer: results from the phase IIb SunRISe-1 study. J Clin Oncol. 2025;43(33):3578-3588. |
| 2 |