SUMMARY

• Johnson & Johnson does not recommend any practices, procedures or usage that deviate from the product labeling or are not approved by the regulatory agencies.
• Please refer to the full Prescribing Information and the Instructions for Use of INLEXZO for more information on DOSAGE AND ADMINISTRATION.^1,2
• INLEXZO (gemcitabine intravesical system) is an intravesical drug releasing system (iDRS), referred to as TAR-200 in literature.³
• 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.¹
• The recommended dosage and administration of INLEXZO are provided in the sections¹:
  • DOSING SCHEDULE OF INLEXZO
  • PREPARATION, INSERTION, AND REMOVAL OF INLEXZO

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.

DOSING SCHEDULE OF INLEXZO

Recommended Dosage¹

• Insert INLEXZO (225 mg of gemcitabine) into the bladder once every 3 weeks for up to 6 months (8 doses), followed by once every 12 weeks for up to 18 months (6 doses), or until persistent or recurrent NMIBC, disease progression, or unacceptable toxicity.
• Remove INLEXZO after each 3-week indwelling period.

Missed Dose¹

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

Contraindication¹ 

• INLEXZO is contraindicated in patients with:
  • Perforation of the bladder [See Warning and Precautions (5.1) section of the Prescribing Information].
  • Prior hypersensitivity reactions to gemcitabine or any component of the product.

Preparation, INsertion, and Removal of INLEXZO

Important Administration Instructions¹

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

Preparation and Intravesical Administration¹ 

• 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.
  • 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.² 
  • If contact with INLEXZO is suspected, immediately wash the skin thoroughly or rinse the mucosa with copious amounts of water.² 
• Instruct patients to drink approximately 1500 mL 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.
• 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.

Important Information² 

• Use aseptic technique during insertion and removal of INLEXZO.
• Follow these instructions carefully, to avoid patient injury and ensure proper functioning.
• Insertion: To ensure proper insertion of INLEXZO and to avoid damage to INLEXZO, use only the following:
  • Water-based lubricant
  • Urinary catheter and stylet (supplied).
• 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.
• Do not use any components that are damaged or have damaged packaging.
• Check the expiration ('EXP') date before use.
• Do not use INLEXZO if expiration date has passed.
• Removal: To ensure proper INLEXZO removal and to avoid damage to INLEXZO and/or cystoscope, use only the following:
  • Non-cutting, grasping forceps
  • Flexible or rigid cystoscope
• 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 United States Pharmacopeia Controlled Room Temperature].

See the Instructions for Use enclosed in the carton for complete information on preparation and intravesical administration. Review the Instructions for Use prior to insertion and removal of INLEXZO.¹ 

1. Prepare Components for INLEXZO Insertion² 

1A. Gather supplies.

• Included in the product carton:
  • One sterile INLEXZO
  • One sterile urinary catheter and one sterile stylet
• Not included in the product carton:
  • Multiple pairs of gloves
  • Two 10 mL prefilled water-based lubricant syringes OR
  • Two empty 10 mL syringes and water-based lubricant

1B. Put on gloves

1C. Prepare two syringes with sterile water-based lubricant

• Remove each sterile syringe prefilled with water-based lubricant from its packaging and place each syringe on the sterile work surface using aseptic technique. OR
• Fill each of the two empty syringes with 2 mL to 3 mL of water-based lubricant plus additional lubricant for urinary catheter tip lubrication.
• Place each lubricant syringes on a sterile work surface using aseptic technique.
• The lubricant is to be used to lubricate the tip of the urinary catheter and to facilitate the deployment of INLEXZO.

1D. Open the INLEXZO foil pouch.

• Tear open the INLEXZO outer foil pouch at tear notch.
• Remove the white INLEXZO inner pouch.
• The outside surfaces of white component pouches are not sterile.

1E. Examine the white component pouches for damage.

• Check the white INLEXZO pouch and white pouch containing the urinary catheter and stylet for damage (e.g., cuts, tears, punctures) that could compromise sterility of the components before opening.
• Do not use if packaging is damaged.
• Surfaces of the white INLEXZO pouch and the white component pouches are not sterile.

1F. Open the white component pouches and transfer the contents onto sterile work surface.

• Open the white INLEXZO pouch and transfer INLEXZO onto a sterile work surface.
• Do not remove plastic sleeves from INLEXZO.
• Open the white pouch containing the urinary catheter and stylet and transfer the contents onto a sterile work surface.

1G. Put on sterile gloves.

• Ensure your patient is prepared for the procedure.
• Put on sterile gloves.

1H. Remove plastic sleeves.

• Remove the plastic sleeves from INLEXZO.

1I. Inspect components.

• Inspect INLEXZO, the urinary catheter, and green stylet for damage.
• Do not use if the urinary catheter or green stylet are damaged or if the outer surface of INLEXZO is damaged.

2. Insert INLEXZO² 

2A. Lubricate the urinary catheter

• Lubricate tip of the urinary catheter.
• The urinary catheter should be free of INLEXZO and the stylet.

2B. Insert the urinary catheter (without stylet)

• Introduce the urinary catheter into the urethra by hand and advance until urine return. Do not empty the bladder.
• Use depth markings to maintain coudé tip orientation and insertion depth position throughout the procedure.
• Do not excessively force the urinary catheter into the bladder.
• In case of resistance, careful assessment and standard procedural techniques can be performed, as appropriate, in order to safely advance the urinary catheter into the bladder.
• If advancement is obstructed or cause cannot be determined or resolved, withdraw the urinary catheter to avoid patient injury or urinary catheter damage.
• Do not re-use urinary catheter.

2C. Inject lubricant from the first syringe into the urinary catheter

• Inject 2 mL to 3 mL of lubricant from the first syringe into the end of the urinary catheter with the urinary catheter placed in the bladder.

2D. Insert INLEXZO into the urinary catheter.

• Insert either end of INLEXZO into the urinary catheter and advance until fully inserted.

2E. Inject lubricant from the second syringe into the urinary catheter

• Inject 2 mL to 3 mL of lubricant from the second syringe into the urinary catheter to help advance INLEXZO further, with the urinary catheter placed in the bladder.

2F. Insert stylet into the urinary catheter.

• Slowly insert the stylet into the urinary catheter until the stylet hub is flush with end of the urinary catheter. This ensures INLEXZO exits the urinary catheter and enters the bladder.
• If INLEXZO cannot be advanced, remove the urinary catheter and stylet together as a single unit.
  • Ensure INLEXZO is also removed.
  • Do not attempt to re-use the removed INLEXZO.
  • Begin again by obtaining a new carton of INLEXZO including a new urinary catheter and stylet.

2G. Remove the urinary catheter and stylet together as a single unit.

• Do not remove urinary catheter and stylet individually.
• INLEXZO should remain inside bladder.
• Retain Instructions for Use for the removal procedure.

3. Post-Insertion Instructions² 

3A. Provide the completed MRI safety information card to the patient.

• Remove the MRI Safety Information Card from the carton.
• Complete the details and give it to the patient.
• Advise the patient to carry the card and to show their current and future healthcare providers in case of need for MRI scans.
  • INLEXZO contains a metal wire. The patient can safely undergo an MR exam only under very specific conditions (see MRI Safety Information).

3B. Inform the patient and caregivers about the indwelling period.

• The indwelling period is approximately 3 weeks. See INLEXZO PI for additional information.
• Inform the patient and caregivers that INLEXZO will remain in the bladder for the indwelling dosing period.
• INLEXZO contains a hazardous drug. The patient and caregivers should be made aware of the need to exercise caution when handling urine during the indwelling period. See INLEXZO PI for additional information.

4. Removal of INLEXZO After the Indwelling Period² 

4A. Lubricate the cystoscope

• Use a water-based lubricant to lubricate the cystoscope.

4B. Insert the cystoscope.

• Insert the cystoscope into the bladder to locate INLEXZO.

4C. Grasp INLEXZO.

• Introduce non-cutting grasping forceps through the working channel of the cystoscope.
• Do not use cutting forceps.
• Grasp INLEXZO over tubing and metal wire.
• Do not grasp on or near the ends of INLEXZO.
• Grasping near the ends of the INLEXZO could result in exposing the metal wire, potentially causing damage to surrounding tissue.

4D. Remove INLEXZO.

• Remove the cystoscope and forceps out of urethra together to remove INLEXZO under direct vision.
• Do not remove INLEXZO through working channel of cystoscope. Doing so may damage INLEXZO and/or cystoscope.

4E. Inspect INLEXZO.

• After removal, inspect INLEXZO to confirm it is intact and unbroken.

4F. Product Disposal.

• Dispose of used urinary catheter and stylet, INLEXZO, and its packaging per facility procedures and per applicable federal, state, and local regulations.
• Do not re-sterilize/re-use the urinary catheter or stylet. Re-use of the urinary catheter or 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.

LITERATURE SEARCH

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 18 August 2025.