UroGen Announces Approval of a New Treatment Option for Adult Patients With Recurrent LG-IR-NMIBC
See Prescribing Information
On June 12, 2025, the US Food and Drug Administration (FDA) approved ZUSDURI™ (mitomycin) for intravesical solution.
ZUSDURI is the first and only FDA-approved treatment indicated for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).1
ZUSDURI package information
Dispensing pack and description1
1 single-dose kit containing two 40-mg vials of mitomycin and 1 vial of 60-mL hydrogel
Newly approved biologics do not have unique Healthcare Common Procedure Coding System (HCPCS) codes; however, once the FDA allows a service or item to be marketed, providers may use miscellaneous or unclassified codes until the assignment of a permanent code.
The Cencora Specialty GPOs Specialty Practice Network is pleased to announce it has entered into an agreement with UroGen Pharma that will give eligible GPO members discounted pricing and rebate opportunities when purchasing ZUSDURI through Besse Medical.
Please click here for Full Prescribing Information.
WAC=wholesale acquisition cost, or manufacturer’s published price to wholesalers.
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WAC prices do not necessarily reflect actual prices paid by consumers, payers, or dispensers. WAC prices shown are as of June 12, 2025, and are subject to change without notice.
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The content included in this presentation is informational only; does not constitute medical, legal, or professional business consulting advice; and represents no statement, promise, or guarantee of payment. The provider is solely responsible for determining appropriate treatment for the patient based on the unique medical needs of each patient and the independent judgment of the provider. It is also the responsibility of the provider to determine payer-appropriate coding, medical necessity, site of service, documentation requirements, and payment levels and to submit appropriate codes, modifiers, and charges for services rendered. Although we have made every effort to provide information that is current, it is recommended you consult your legal counsel,
reimbursement/compliance advisor, and/or payer organization(s) for interpretation of payer-specific coding, coverage, and payment expectations.
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.
This content is sponsored by UroGen, and Specialty Practice Network has not independently reviewed or verified the information provided by UroGen.
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