Mechanism of Delivery

INLEXZO™ provides prolonged local delivery of gemcitabine into the bladder for weeks, not hours1-3

Of the total gemcitabine dose, 77% was excreted by Day 7 and 99% was excreted by Day 21 in urine as gemcitabine and dFdU1

About INLEXZO™
INLEXZO™ size comparison with two United States quarters, not actual sizeINLEXZO™ size comparison with two United States quarters, not actual size
  • INLEXZO™ is a sterile, non-resorbable intravesical system containing the equivalent of 225 mg gemcitabine (present as 256.3 mg of gemcitabine hydrochloride)1
  • INLEXZO™ contains an almost white to light pink-brown colored gemcitabine component at the center surrounded on each side by off-white to light blue–colored osmotic components1

dFdU, difluorodeoxyuridine.

How INLEXZO™ Works

Illustrative depiction.
Not actual size.

  • INLEXZO™ is inserted via transurethral catheterization and removed via cystoscopy, both familiar,
    in-office procedures4
  • Once inserted, INLEXZO™ curls into a bi-oval shape—like a pretzel—designed to promote retention within
    the bladder1,5
  • INLEXZO™ is freely mobile within the bladder, even after voiding1,5

INLEXZO™ Overview Video

Discover how INLEXZO™ fits into the current treatment landscape, and what makes the drug releasing system unique

Dosing and Administration

INLEXZO™ is administered in a familiar,† in-office procedure in
14 doses over 2 years1

Remove INLEXZO™ after each 3-week indwelling period

recommended dosage timelinerecommended dosage timeline

†Uses catheterization and cystoscopy.4

‡Or until persistent or recurrent NMIBC, disease progression, or unacceptable toxicity.1

§Assumes same-day removal and new insertion during first 6 months.1

∥One dose=insertion and removal 3 weeks later.1

Removal4

Removal4

  • Removal by flexible or rigid cystoscope and non-cutting grasping forceps
  • Removal of INLEXZO™ by cystoscopy provides the opportunity for simultaneous assessment of disease response6

Missed Dose1

Missed Dose1

  • If a dose is missed, it should be administered as closely as possible to the original treatment schedule

Prophylactic Antibiotics1

Prophylactic Antibiotics1

  • Prophylactic antibiotics may be used at the discretion of the treating healthcare provider with each INLEXZO™ insertion and removal

Magnetic Resonance Imaging (MRI) Scans1,4

Magnetic Resonance Imaging (MRI) Scans1,4

  • INLEXZO™ contains a metal wire. When INLEXZO™ is indwelling in the bladder, the patient can only be safely scanned with MRI under certain conditions

Please read full Prescribing Information for INLEXZO™ for specific MRI scanning conditions.

IMPORTANT INFORMATION AND CONSIDERATIONS

Administration Considerations1

Administration Considerations1

  • Administer INLEXZO™ intravesically only. Do NOT administer by any other route. INLEXZO™ is co-packaged with a urinary catheter and stylet used to insert INLEXZO™ through the urinary catheter into the bladder. Administer using the co-packaged urinary catheter and stylet only
  • INLEXZO™ should be inserted and removed by a trained healthcare provider. Healthcare providers should become thoroughly familiar with the insertion and removal instructions before attempting insertion or removal of INLEXZO™

Handling Considerations1

Handling Considerations1

  • INLEXZO™ is a hazardous drug. Follow applicable special handling and disposal procedures while handling INLEXZO™ and during the insertion and removal procedure

Read full Instructions for Use for additional handling considerations.

Patient Counseling Regarding Intravesical Administration1

Patient Counseling Regarding Intravesical Administration1

  • Instruct patients to drink approximately 1500 mL/6-7 cups of fluids per day during therapy with INLEXZO™ to ensure adequate urine production for drug release
  • Instruct patients not to empty the bladder immediately prior to the insertion procedure. Presence of urine in the bladder can facilitate deployment of INLEXZO™. Patients can resume micturition after the insertion procedure
  • Advise patients to avoid contact with urine while INLEXZO™ is indwelling in the bladder for approximately 3 weeks and for at least 24 hours post-removal
  • During indwelling period of approximately 3 weeks, advise patients 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
  • Advise patients to wash clothing soiled with urine promptly and separately from other clothing
  • Complete the MRI Safety Information Card and give it to the patient. Advise the patient to carry the card and show it to their HCP in case of need for MRI scans

Please refer to Section 17 of full Prescribing Information for complete patient counseling information.

Please read full Instructions for Use for complete information on preparation, intravesical administration, and removal.

Watch the Procedural Video for INLEXZO™

This video explains the preparation, insertion, removal, and disposal of INLEXZO™

For details on insertion and removal, please read full Instructions for Use.

VIEW RESOURCES FOR HEALTHCARE PROFESSIONALS

99% (745/755) of attempted insertions were successful (N=85 patients)5

A successful insertion of INLEXZO™ was defined as obtaining transurethral access to the bladder using the urinary catheter with the ability to fully advance the stylet until INLEXZO™ was deployed in the bladder.

Disclaimer: This information is not in the Prescribing Information. It is being provided for descriptive purposes; results require cautious interpretation.

Storage and Handling

The only off-the-shelf FDA-approved intravesical product for BCG-UR NMIBC CIS: INLEXZO™ can be stored at room temperature and does not require special preparation prior to use1,7-11#

Storage1

Store in the original carton at 20°-25°C (68º-77ºF)

expand icon

Handling1

  • INLEXZO™ is a hazardous drug. Follow applicable special handling and disposal procedures
  • Carton includes one sterile single dose of INLEXZO™ co-packaged with one sterile urinary catheter and one sterile stylet
stylet and catheter shaftstylet and catheter shaft

Please read the full Prescribing Information and Instructions for Use for complete information on how to prepare and administer INLEXZO™.

BCG, Bacillus Calmette–Guérin; CIS, carcinoma in situ; NMIBC, non–muscle invasive bladder cancer; UR, unresponsive.
As of 09/25.
#INLEXZO™ does not require freezing, refrigeration, reconstitution, or use of a hood for preparation.1
EXPLORE EFFICACY
References: 1. INLEXZO™ [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc. 3. Palugan L, Cerea M, Cirilli M, et al. Intravesical drug delivery approaches for improved therapy of urinary bladder diseases. Int J Pharm X. 2021;3:100100. doi:10.1016/j.ijpx.2021.100100 4. INLEXZO™ [Instructions for Use]. Horsham, PA: Janssen Biotech, Inc.
5. Daneshmand S, Kamat AM, Shore ND, et al. Development of TAR-200: a novel targeted releasing system designed to provide sustained delivery of gemcitabine for patients with bladder cancer. Urol Oncol. 2025;43(5):286-296. doi:10.1016j.urolonc.2024.12.264 6. Treatment of bladder cancer, based on the stage and other factors. American Cancer Society. Accessed August 19, 2025. https://www.cancer.org/cancer/types/bladder-cancer/treating/by-stage.html 7. Adstiladrin® [Prescribing Information]. Parsippany,
NJ: Ferring Pharmaceuticals. 2024. 8. Anktiva® [Prescribing Information]. San Diego, CA:
ImmunityBio. 2024. 9. Tice® BCG [Prescribing Information]. Durham, NC: Merck Teknika LLC. 2022. 10. Jelmyto® [Prescribing Information]. Princeton, NJ: UroGen Pharma, Inc. 2024. 11. Valstar® [Prescribing Information]. Malvern, PA: Endo USA. 2019.