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Chill, Fill, Instill: ZUSDURI administration

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ZUSDURI is administered intravesically in an office or an outpatient setting by a trained healthcare professional1

Chill icon

Chill2

  • Place the reconstituted ZUSDURI vial in a plastic bag
  • Place the plastic bag in an ice bath (ice and cold water in any container) to chill ZUSDURI for approximately 20 minutes to revert it to liquid form

Fill icon

Fill2

  • Fill 4 administration syringes with 14 mL of ZUSDURI admixture (for a total of 56 mL)
  • Place the 4 administration syringes in the plastic bag and place the plastic bag in the ice bath, ensuring the syringes are completely immersed, for at least 2 minutes

Instill icon

Instill2

  • Inject each syringe into the catheter and move to the next syringe quickly to minimize risk of residual gel warming and obstruction
  • Each syringe must be emptied within 30 seconds
  • Wait 15 minutes before removing the catheter

The indicated dosage of ZUSDURI is 75 mg (56 mL) instilled once weekly for 6 weeks into the bladder2


For complete directions, please see the Instructions for Administration.

With ZUSDURI, there is no need for general anesthesia, urine retention,* or rotating positions2,3

*Patients should avoid contact with their urine for at least 24 hours.2

Review coverage details for ZUSDURI

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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. ZUSDURI [package insert]. Princeton, NJ: UroGen Pharma, Inc.; 2025. 3. 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 May 23, 2025. https://www.auanet.org/about-us/aua-statements/intravesical-administration-of-therapeutic-medication

IMPORTANT SAFETY INFORMATION

ZUSDURI is indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

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.