A familiar safety profile for urologists: The 2 most common adverse reactions (AR) were urinary frequency (48%) and urinary tract infection (UTI) (44%)1
- Serious ARs occurred in 24% of patients receiving INLEXZO1*
- Serious ARs that occurred in >2% of patients included UTI, hematuria, pneumonia, and urinary tract pain1
- Fatal ARs occurred in 1.2% of patients (n=1) who received INLEXZO, including cognitive disorder1
Most common ARs occurring in >15% of patients1
| Adverse Reaction | INLEXZO (N=85†) | |
|---|---|---|
| All Grades (%) | Grades 3 or 4 (%) | |
| Urinary frequency | 48 | 0 |
| Urinary tract infection | 44 | 6 |
| Dysuria | 42 | 0 |
| Micturition urgency | 34 | 0 |
| Urinary tract pain | 26 | 7 |
| Hematuria | 24 | 2.4 |
| Bladder irritation | 16 | 0 |
Other clinically significant ARs (<15%) included fatigue (14%), genital pain (12%), diarrhea (11%), urinary incontinence (9%), urinary retention (7%), and nocturia (4.7%).1
Additional safety data
Disclaimer: This information is not in the Prescribing Information. It is being provided for descriptive purposes; results require cautious interpretation.
Median onset of ARs occurred within the first ~4 doses (median 11.8 weeks; range: 0.1+ to 98.3 weeks)2
ARs resolved‡ within ~3 weeks
(median 2.6 weeks; range: 0.1+ to 113.9 weeks)2
Duration of ARs was defined as the time from onset of ARs to resolution of event or clinical cutoff date if event was ongoing.
This was an analysis of ARs occurring in >15% of patients included in the Prescribing Information.
Select laboratory abnormalities (>15%) that worsened from baseline1
| Laboratory Abnormality | INLEXZO§ | |
|---|---|---|
| All Grades (%) | Grades 3 or 4 (%) | |
| Hematology | ||
| Decreased hemoglobin | 31 | 1.2 |
| Decreased lymphocytes | 24 | 4.8 |
| Chemistry | ||
| Increased lipase | 28 | 12 |
| Increased creatinine | 24 | 0 |
| Increased potassium | 22 | 1.2 |
| Increased AST | 17 | 1.2 |
| Decreased sodium | 16 | 4.8 |
| Increased ALT | 16 | 1.2 |
*A serious AR results in death, life-threatening conditions, hospitalization, disability or permanent damage, congenital anomalies or birth defects, or important medical events that require intervention to prevent one of the other outcomes.3
†The safety of INLEXZO monotherapy was evaluated in Cohort 2 of SunRISe-1, a multi-center, open-label study in 85 adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors.1
‡The majority of ARs resolved: 89% (315/354).2
§The denominator used to calculate the rate varied from 82 to 83 based on the number of patients with a baseline value and at least one posttreatment value.1
INLEXZO has a proven safety profile: 7% treatment discontinuations1
41% of patients experienced dosage interruptions due to ARs1
ARs requiring dosage interruption in >3% of patients included:
- Urinary tract infection
- Urinary tract pain
- Hematuria
- Urinary frequency
- Micturition urgency
- Dysuria
- Genital pain
7% of patients permanently discontinued treatment due to ARs1
ARs which resulted in permanent treatment discontinuation (>1%) included:
- Bladder irritation
- Urinary frequency
- Cognitive disorder
- Hydronephrosis
- Urinary tract disorder
Patient management strategies and support
Prophylaxis
Prescribing Information
- Prophylactic antibiotics may be used at the discretion of the treating healthcare provider with each INLEXZO insertion and removal1
SunRISe-1 protocol
The following are not recommendations in the Prescribing Information and are at the discretion of the healthcare provider.
Investigators were instructed to4:
- Administer at least 1 dose of prophylactic periprocedural antibiotics for any INLEXZO insertion or removal
- Consider prophylactic administration of anticholinergics, NSAIDs, and bladder analgesics
Fluid intake
Instruct patients to drink approximately 1500 mL/6-7 cups of fluid per day during therapy with INLEXZO to ensure adequate urine production for drug release.1
Additional Information for Patients
Help patients be aware of potential LUTS, including dysuria, pollakiuria (abnormally frequent urination), and micturition urgency, prior to treatment initiation and throughout the treatment course, and screen for preexisting LUTS. Counsel patients to reduce caffeine and alcohol intake, which can exacerbate overactive bladder symptoms and urinary urgency.5,6
LUTS, lower urinary tract symptoms.
References: 1. INLEXZO™ [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc. 3. U.S. Food & Drug Administration. Accessed May 21, 2026. https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event 4. Daneshmand S, Van der Heijden MS, Jacob J, et al. TAR-200 for bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer: results from the phase IIb SunRISe-1 study. Clinical Protocol. J Clin Oncol. 2025;43(33):3578-3588. Accessed June 11, 2026. https://ascopubs.org/action/downloadSupplement?doi=10.1200/JCO-25-01651&file=protocol_JCO-25-01651.pdf 5. 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. Curr Opin Urol. 2026;36(1):123-133. doi:10.1097/MOU.0000000000001350 6. Wei JT, Dauw CA, Brodsky CN. Lower urinary tract symptoms in men: a review. JAMA. 2025;334(9):809-821. doi:10.1001/jama.2025.7045