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Get patients startedUntil now there were no FDA-approved medications for recurrent LG‑IR‑NMIBC1
There remain significant unmet needs for recurrent patients:
Recurrence2*
It is estimated:
- ~68% of recurrent patients have 2 or more recurrences
- ~23% of recurrent patients have 5 or more recurrences
Repeated Surgery3‐5
Upon recurrence, the most common treatment today is repeated surgery with general anesthesia
With Current IVTs6‐8
Some patients may have difficulty retaining urine for the recommended 1-2 hours. This may result in decreased dwell time
*UroGen projections based on published literature.
IVT=intravesical therapy; LG-IR-NMIBC=low-grade intermediate-risk non-muscle invasive bladder cancer.
References: 1. Prasad SM, Shishkov D, Vladimirov Mihaylov N, et al. Primary chemoablation of recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer with UGN-102: a single-arm, open-label, phase 3 trial (ENVISION). J Urol. 2025;213(2):205-216. 2. Data on file. UroGen Pharma Inc., Princeton, NJ. 3. Malde S, Grover S, Raj S, et al. A systematic review of the efficacy and safety of outpatient bladder tumour ablation. Eur Urol Focus. 2022;8(1):141-151. 4. Gregg JR, McCormick B, Wang L, et al. Short term complications from transurethral resection of bladder tumor. Can J Urol. 2016;23(2):8198-8203. 5. Bladder cancer surgery. American Cancer Society. Updated March 12, 2024. Accessed April 2, 2025. https://www.cancer.org/cancer/types/bladder-cancer/treating/surgery.html 6. Baumgartner R, Chang S, Flick S, et al. Intravesical administration of therapeutic medication for the treatment of bladder cancer. American Urological Association. Updated June 2020. Accessed April 2, 2025. https://www.auanet.org/about-us/aua-statements/intravesical-administration-of-therapeutic-medication 7. What is non-muscle invasive bladder cancer? Urology Care Foundation. Updated June 2024. Accessed April 2, 2025. https://www.urologyhealth.org/urology-a-z/n/non-muscle-invasive-bladder-cancer 8. Douglass L, Schoenberg M. The future of intravesical drug delivery for non-muscle invasive bladder cancer. Bladder Cancer. 2016;2(3):285-292.
Indications and Usage
ZUSDURI™ is indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
IMPORTANT SAFETY INFORMATION
Contraindications
ZUSDURI is contraindicated in patients with perforation of the bladder or in patients with prior hypersensitivity reactions to mitomycin or any component of the product.
Warnings and Precautions
Risks in Patients with Perforated Bladder
ZUSDURI may lead to systemic exposure to mitomycin and severe adverse reactions if administered to patients with a perforated bladder or to those in whom the integrity of the bladder mucosa has been compromised. Evaluate the bladder before the intravesical instillation of ZUSDURI and do not administer to patients with a perforated bladder or mucosal compromise until bladder integrity has been restored.
Embryo-Fetal Toxicity
Based on findings in animals and mechanism of action, ZUSDURI can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of mitomycin resulted in teratogenicity. Advise females of reproductive potential to use effective contraception during treatment with ZUSDURI and for 6 months following the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ZUSDURI and for 3 months following the last dose.
Adverse Reactions
Common Adverse Reactions
The most common (≥10%) adverse reactions, including laboratory abnormalities, that occurred in patients treated with ZUSDURI were increased creatinine, increased potassium, dysuria, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, increased eosinophils, decreased lymphocytes, urinary tract infection, decreased neutrophils, and hematuria.
Additional Adverse Reactions Information
Clinically relevant adverse reactions occurring in <10% of patients who received ZUSDURI included increased urinary frequency, fatigue, urinary incontinence, urinary retention, urethral stenosis, genital pain, urinary urgency, genital edema, genital pruritus, genital rash, urethritis, acute kidney injury, balanoposthitis, and nocturia.
Use in Specific Populations
Lactation
Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with ZUSDURI and for 1 week following the last dose.
Preparation and Administration Information
ZUSDURI is to be administered by intravesical instillation only. Do not administer ZUSDURI by pyelocalyceal instillation or by any other route.
ZUSDURI must be prepared and administered by a healthcare provider. To ensure proper dosing, it is important to follow the preparation instructions found in the ZUSDURI Instructions for Pharmacy and administration instructions found in the ZUSDURI Instructions for Administration.
ZUSDURI may discolor urine to a violet to blue color following the instillation procedure. Advise patients for at least 24 hours post-instillation to avoid urine contact with skin, to void urine sitting on a toilet, and to flush the toilet several times after use. Advise patients to wash hands, perineum or glans with soap and water after each instillation procedure.
ZUSDURI is a hazardous drug. Follow applicable special handling and disposal procedures.
Please click here for Full Prescribing Information, Instructions for Pharmacy, and Instructions for Administration.