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Download the Patient Enrollment Form to order ZUSDURI and access support services for eligible patients
Get patients startedResources for your practice
The following downloads, links, and forms are designed to support you and your practice in seamlessly navigating your patient's treatment journey with ZUSDURI
Support and affordability
ZUSDURI Product Fact Sheet
Contains important ZUSDURI product information and specifications, including NDC; WAC price; and supply, storage, and handling information.
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Misc. J-Code Flashcard
Provides miscellaneous billing codes to use for ZUSDURI until a permanent code is assigned.
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Access and Reimbursement Guide
A comprehensive resource for ZUSDURI access information, including billing and coding support.
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Ordering and Scheduling Guide
A brochure outlining the 4 simple steps for getting started with UroGen® products.
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Affordability Brochure
A brochure outlining financial support programs that are available for eligible patients who have been prescribed UroGen products.
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Forms and documents
ZUSDURI Patient Enrollment Form
Patient enrollment form used to enroll eligible patients in UroGen Support™.
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Prior Authorization Checklist
Provides information that is generally used to determine medical necessity by payor.
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Letter of Medical Necessity
Customizable letter supporting the use of ZUSDURI in appropriate patients.
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Annotated 1450 Claims Form
Provides information which may be used as a reference when billing for ZUSDURI and its administration in the hospital outpatient department setting.
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Annotated 1500 Claims Form
Provides information which may be used as a reference when billing for ZUSDURI and its administration in the physician office setting.
DownloadNDC=National Drug Code; WAC=wholesale acquisition cost.
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.