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INLEXZO™

(gemcitabine intravesical system)

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INLEXZO™ (gemcitabine intravesical system)

Medical Information

INLEXZO - Renal and Urinary Disorders

Last Updated: 10/22/2025

SUMMARY

  • INLEXZO (gemcitabine intravesical system) is an intravesical drug releasing system (iDRS), referred to as TAR-200 in literature.1 
  • SunRISe-1 (NCT04640623) is an ongoing, phase 2b, open-label, randomized, parallel-cohort, multicenter study evaluating the efficacy and safety of INLEXZO plus systemic cetrelimab (investigational IgG4 antibody targeting PD-1 receptor; cohort 1), INLEXZO monotherapy (cohort 2), or cetrelimab monotherapy (cohort 3) in patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary disease who are ineligible for or decline radical cystectomy (RC). INLEXZO monotherapy is additionally being studied in patients with BCG-unresponsive papillary-only high-risk NMIBC (no CIS; cohort 4, per protocol amendment).1-3 
    • As of March 31, 2025, 85 patients were treated with INLEXZO monotherapy (cohort 2).1 
    • The most common treatment-related adverse events (TRAEs; any grade) associated with renal and urinary disorders are reported in Incidence of TRAEs Associated With Renal and Urinary Disorders in the INLEXZO Monotherapy Group (Cohort 2).1
    • The most frequent grade ≥3 TRAEs associated with renal and urinary disorders included urinary tract pain (4 [4.7%] patients) and bladder pain (2 [2.4%] patients).1
  • Pradere et al (2025)4 summarized the clinical management of side effects associated with iDRSs, such as INLEXZO. For clinical management of side effects associated with iDRSs, refer to Recommendations for the Management of Side Effects Associated With iDRS Treatment.4

Product Labeling

CLINICAL DATA

SunRISe-1 Study

The results of the SunRISe-1 study are also included in the INLEXZO product labeling. The safety results below may vary from that in the INLEXZO product labeling due to the difference in evaluation of the individual safety events, contributing to differences in reported n-values and percentages.

Daneshmand et al (2025)1 summarized the 1-year results, including the TRAEs associated with renal and urinary disorders with INLEXZO monotherapy in BCG-unresponsive high-risk NMIBC with CIS with or without papillary disease (cohort 2).

Study Design/Methods

  • Phase 2b, ongoing, randomized, open-label, parallel-cohort, multicenter study1-3
  • Patients in cohort 2 received INLEXZO (indwelling) monotherapy every 3 weeks for the first 24 weeks (6 months) and then every 12 weeks through week 96 (year 2).1-3
    • Patients continued treatment with INLEXZO for up to 2 years or until confirmed high-risk disease persistence, recurrence, or progressive disease based on central urine cytology and/or central biopsy assessment or local biopsy/local imaging.1 

Results


Incidence of TRAEs Associated With Renal and Urinary Disorders in the INLEXZO Monotherapy Group (Cohort 2)1 
Most Frequent ≥1 TRAEs,a n (%)
INLEXZO Monotherapy (Cohort 2)
(n=85)
Any Gradeb
Grade ≥3c
Pollakiuria
37 (43.5)
0
Dysuria
34 (40)
0
Micturition urgency
21 (24.7)
0
Urinary tract infection
18 (21.2)
1 (1.2)
Hematuria
14 (16.5)
0
Urinary tract pain
9 (10.6)
4 (4.7)
Bladder pain
7 (8.2)
2 (2.4)
Bladder spasm
7 (8.2)
0
Noninfective cystitis
6 (7.1)
0
Urinary incontinence
5 (5.9)
0
Nocturia
4 (4.7)
0
Urethral pain
4 (4.7)
0
Urinary retention
4 (4.7)
1 (1.2)
Cystitis
3 (3.5)
1 (1.2)
Lower urinary tract symptoms
3 (3.5)
0
Urethral injury
2 (2.4)
0
Abbreviations: AE, adverse event; TRAE, treatment-related adverse event.aAn AE was categorized as related if the investigator determined that there was a possible, probable, or causal relationship between the AE and INLEXZO or procedure.bAny-grade TRAEs by preferred term are listed if they were reported in ≥2% of patients.
cOther grade ≥3 TRAEs included acute kidney injury, pseudomonal cystitis, and urosepsis (n=1 each). Note, patients may have had ≥1 grade ≥3 TRAEs.
Note: Safety data are shown for all patients who received ≥1 dose of the study drug in the full analysis set. Patients are counted only once for any given event, regardless of the number of times they actually experienced the event.
  • Serious TRAEs (n=1 each) included cystitis with bladder pain (grade 2), pseudomonal cystitis (grade 3), urinary tract infection (grade 3), urosepsis with acute kidney injury (grade 3), and urinary tract pain (grade 3).1 
    • Note, patients may have had ≥1 serious TRAE.
  • The most frequent INLEXZO-related AEs leading to interruption were urinary tract pain (5.9%), hematuria (4.7%), and pollakiuria (4.7%).1 
    • INLEXZO interruption is defined as when an INLEXZO dose is skipped or INLEXZO is removed early.
    • Most patients had 1-2 skipped INLEXZO doses and most patients resumed treatment.
  • TRAEs leading to INLEXZO discontinuation included noninfective cystitis (n=2; 2.4%), pollakiuria (n=1; 1.2%), and urinary tract disorder (n=1; 1.2%).1 
    • Note, patients who discontinued may have had ≥1 TRAE.

RECOMMENDATIONs FOR THE MANAGEMENT OF SIDE EFFECTS ASSOCIATED with IdRs treatment

Pradere et al (2025)4 summarized clinical management recommendations from a panel of urologists and oncologists with experience in iDRS clinical trials (SunRISe and MoonRISe).

General Principles and Prophylactic Measures

The general recommendations for the management of iDRS-associated side effects include the following:

  • Counsel patients prior to and during the treatment course on potential LUTS and their management. Assessing for preexisting LUTS before treatment initiation, particularly in males with storage symptoms per International Prostate Symptom Score, is crucial as these may worsen with iDRS treatment.4
  • Instruct patients to consume at least 1500 mL (approximately 6.5 cups) of nonalcoholic, noncaffeinated liquids daily during the iDRS dosing period to promote adequate urine production.4
  • Patients with ongoing LUTS or a history of LUTS prior to treatment should be advised to avoid bladder irritants (eg, spicy foods, caffeine, citrus fruits). If LUTS occur, urinalysis and urine culture should be conducted, and, if UTI is present, treatment should be as per the standard practice.4

The recommendations for iDRS toxicity management are shown in the figure: Flowchart of Expert Panel Recommendations for iDRS Toxicity Management

Flowchart of Expert Panel Recommendations for iDRS Toxicity Management4

Abbreviations: h, hours; iDRS, intravesical drug-releasing system; LUTS, lower urinary tract symptoms; NSAID, nonsteroidal anti-inflammatory drug; OAB, overactive bladder; PDE-5, phosphodiesterase-5; PTNS, percutaneous tibial nerve stimulation; UTI, urinary tract infection; WHO, World Health Organization.

Management of UTI

  • Recommendations for the management of UTI following iDRS treatment are summarized in the table: Expert Recommendations for the Management of UTI and Bacteriuria.
  • The first step in the management of UTI in patients receiving iDRS treatment is the initiation of antibiotics that are selected based on urinalysis and urine culture results.4

Expert Recommendations for the Management of UTI and Bacteriuria4
Definition
iDRS Management
Symptom Management
Asymptomatic bacteriuria
  • Continue iDRS
  • Encourage adequate hydration
  • Consider tailored antibiotic treatment based on antibiogram results if symptoms develop, in accordance with institutional guidance
UTI, without fevera
  • iDRS may remain in the bladder, if there is clinical improvement on antibiotic treatment
  • After 48-72 h of culture-directed antibiotics with no clinical improvement, and based on clinical judgment, consider removal/delaying insertion of a new iDRS until clinical improvement
  • After complete resolution of infection and negative urine culture, iDRS treatment can be resumed
  • Encourage adequate hydration
  • Collect urinalysis and urine culture
  • Start culture-directed oral antibiotics in accordance with institutional guidance
UTI, with fevera
  • iDRS may remain in the bladder, if there is clinical improvement on antibiotic treatment
  • To avoid instrumentation and risks of seeding infection, current indwelling iDRS can remain in the bladder for at least 48 h of culture-directed antibiotics
  • After 48-72 h of culture-directed antibiotics with no clinical improvement, and based on clinical judgment, iDRS should be removed
  • After complete resolution of infection and negative urine culture, iDRS treatment can be resumed
  • Encourage adequate hydration
  • Collect urinalysis, urine culture, and consider blood culture
  • Start broad-spectrum antibiotics in accordance with institutional guidance, tailor to antibiogram
Urosepsisb
  • Remove iDRS when the patient is clinically stable, after starting broad-spectrum antibiotics
  • After complete resolution of infection and negative urine culture, resumption of iDRS treatment can be considered; consider proactive UTI prevention strategy
  • Urgent management, hospitalization, adequate hydration
  • Urine culture and blood culture
  • Start broad-spectrum antibiotics in accordance with institutional guidance, tailor to antibiogram
Abbreviations: CFU, colony forming units; h, hours; iDRS, intravesical drug-releasing system; UTI, urinary tract infection.aUTI is defined as a symptomatic infection with a positive urine culture with a bacterial count of ≥105 CFU/mL in urine voided from women or >104 CFU/mL in urine voided from men or in straight-catheter urine from women that cannot be cleared with antibiotic therapy.bUrosepsis is defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection originating from the urinary tract and/or male genital organs.

Management of Dysuria in the Absence of UTI


Expert Recommendations for the Management of Dysuria4
Definition
iDRS Management
Symptom Management
Painful or burning sensation during urination
  • Continue iDRS and initiate symptom management
  • Depending on clinical improvement following symptom management, consider removal/delaying insertion of a new iDRS
  • When symptoms improve, iDRS treatment can be resumed
  • Encourage adequate hydration
  • Collect urinalysis and urine culture
  • Avoid irritants (caffeine, alcohol, spicy food)
  • Consider:
    • Alpha-blockers (eg, tamsulosin, alfuzosin, silodosin)
    • Antispasmodics (dicyclomine, hyoscyamine, scopolamine)
    • Phenazopyridine, if available per local regulation
    • NSAIDs
    • Amitryptyline (at low dose)
  • Review recommendations for the management of OAB symptoms for further guidance
Abbreviations: iDRS, intravesical drug-releasing system; NSAID, nonsteroidal anti-inflammatory drug; OAB, overactive bladder.

Management of Overactive Bladder (OAB) Symptoms and Bladder Pain


Expert Recommendations for the Management of OAB Symptoms and Pain4
Definition
iDRS Management
Symptom Management
Increase in micturition urgency, micturition frequency (pollakiuria), new onset of incontinence, nocturia, or pain
  • Continue iDRS and initiate symptom management
  • Depending on clinical improvement following symptom management, consider removal/delaying insertion of a new iDRS
  • When symptoms improve, iDRS treatment can be resumed
Conservative measures
  • Consider adequate hydration
  • Collect urinalysis and urine culture
  • Avoid irritants (caffeine, alcohol, spicy food)
  • Consider distraction techniques, bladder retraining, and/or pelvic floor muscle training

OAB management
  • Start anticholinergic drugs (eg, oxybutynin, trospium, solifenacin, fesoterodine) or beta-3 agonists (eg, mirabegron, vibegron) in the absence of contraindications
  • After initiating anticholinergic drugs, consider checking PVR and bowel function (constipation)
  • Consider adding LUTS treatment (alpha-blockers [eg, tamsulosin, alfuzosin, silodosin])
  • In male patients with outlet obstruction, consider adding 5-alpha reductase inhibitors (eg, finasteride) or PDE-5 inhibitors (eg, tadalafil)
  • Consider cystoscopy to evaluate mucosal irritation (if urine culture is negative and OAB symptoms persist); a short course of corticosteroids can be considered

Pain management
  • Consider step 1 of the WHO 3-step analgesic ladder
    • Nonopioid analgesics such as NSAIDs or acetaminophen
  • For persistent pain, despite nonopioid analgesics, consider adding phenazopyridine (if available per local regulation) and/or antispasmodics (eg, dicyclomine, hyoscyamine, scopolamine)
  • For persistent pain, despite the above measures, consider adding step 2 of the WHO 3-step analgesic ladder
  • Moderate pain: weak opioids (hydrocodone, codeine, tramadol) with or without nonopioid analgesics
Abbreviations: iDRS, intravesical drug-releasing system; LUTS, lower urinary tract symptoms; NSAID, nonsteroidal anti-inflammatory drug; OAB, overactive bladder; PDE-5, phosphodiesterase-5; PVR, postvoid residual; WHO, World Health Organization.

Management of Hematuria


Expert Recommendations for the Management of Hematuria4
Definition
iDRS Management
Symptom Management
Macroscopic hematuria: hematuria with no clots, with no signs of retention, and negative urine culture
  • Continue iDRS
  • Encourage adequate hydration
  • Collect urinalysis and urine culture
  • If hematuria persists, perform cystoscopy to evaluate the presence/recurrence of bladder tumors
Complicated hematuria: hematuria with clots leading to retention and/or dysuria or hematuria with anemia
  • iDRS will be removed and the insertion of the new iDRS will be delayed in case of refractory or recurrent hematuria, leading to blood transfusions or requiring hospital admissions
  • After complete resolution of hematuria, iDRS treatment can be resumed based on clinical judgement
  • Encourage adequate hydration
  • Collect urinalysis, urine culture, and blood count
  • Urinary catheter placement or (continuous) bladder irrigation indicated
  • Consider performing ultrasound to rule out bladder clots
  • Consider invasive intervention as clinically indicated
  • Treat anemia, when clinically indicated, in accordance with institutional guidance
  • In case of obstruction, urgent intervention is needed (eg, clot evacuation)
Abbreviation: iDRS, intravesical drug-releasing system.

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 13 October 2025.

Summarized in this response are relevant data limited to INLEXZO monotherapy (cohort 2) of the phase 2b SunRISe-1 study in patients with BCG-unresponsive high-risk NMIBC with CIS with or without papillary tumors.

References

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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. [published online ahead of print July 30, 2025]. J Clin Oncol. doi:10.1200/jco-25-01651.  
2 Janssen Research & Development, LLC. Phase 2b clinical study evaluating efficacy and safety of TAR-200 in combination with cetrelimab, TAR-200 alone, or cetrelimab alone in participants with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to intravesical Bacillus Calmette-Guerin (BCG) who are ineligible for or elected not to undergo radical cystectomy. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 October 13]. Available from: https://clinicaltrials.gov/ct2/show/NCT04640623 NLM Identifier: NCT04640623.  
3 Daneshmand S, van der Hejiden MS, Jacob JM, et al. Supplement to: TAR-200 for Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer: results from the phase IIb SunRISe-1 study. [published online ahead of print July 30, 2025]. J Clin Oncol. doi:10.1200/jco-25-01651.  
4 Pradere B, Schuit M, Guerrero-Ramos F, et al. Side effect management and procedural best practices with indwelling intravesical drug-releasing systems in the treatment of bladder cancer: recommendations from expert panels. [published online ahead of print October 08, 2025]. Curr Opin Urol. doi:10.1097/mou.0000000000001350.  
5 INLEXZO (gemcitabine intravesical system) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/INLEXZO-pi.pdf