ZUSDURI
Mitomycin · KIT · UroGen Pharma, Inc
ZUSDURI is a kit containing mitomycin. Manufactured by UroGen Pharma, Inc.
Key Facts
- Brand Name
- ZUSDURI
- Generic Name
- Mitomycin
- NDC Code (Product)
72493-106- Manufacturer
- UroGen Pharma, Inc
- Dosage Form
- KIT
- Marketing Status
- Application #
- NDA215793
- Marketing Start
- 07/01/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 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). ZUSDURI is an alkylating drug indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administer ZUSDURI by intravesical instillation only. Do not administer by pyelocalyceal instillation or by any other route. ( 2.1 ) The recommended dose of ZUSDURI is 75 mg (56 mL) instilled once weekly for six weeks. ( 2.2 ) 2.1 Important Administration Instructions Administer ZUSDURI by intravesical instillation only. Do not administer by pyelocalyceal instillation or by any other route. 2.2 Recommended Dose The recommended dose of ZUSDURI is 75 mg (56 mL) instilled once weekly for six weeks into the bladder via a urinary catheter. [see Dosage and Administration (2.4) ] 2.3 Preparation Instructions See the Instructions for Pharmacy enclosed in the carton for complete information on preparation. ZUSDURI must be reconstituted with sterile hydrogel under chilled conditions. Reconstituted ZUSDURI has reverse thermal properties with a gelation point of approximately 19°C (66°F) and will appear as a viscous liquid under chilled conditions and a semisolid gel at room temperature. Storage Instructions for Reconstituted ZUSDURI: Instill reconstituted ZUSDURI as soon as possible. If not used immediately, store reconstituted ZUSDURI: under refrigeration at 2℃ to…
Contraindications
4 CONTRAINDICATIONS ZUSDURI is contraindicated in patients with: Perforation of the bladder [see Warnings and Precautions (5.1) ], Prior hypersensitivity reactions to mitomycin or any component of the product. Perforation of the bladder, ( 4 ) Prior hypersensitivity reaction to mitomycin or any component of the product. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The most common (≥ 10%) adverse reactions, including laboratory abnormalities, that occurred in patients 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact UroGen Pharma at 1-855-987-6436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice. The safety of ZUSDURI was evaluated in ENVISION, a single-arm, multicenter study in 240 patients with recurrent LG-IR-NMIBC [see Clinical Studies (14) ]. Patients received 75 mg ZUSDURI instilled once a week for 6 consecutive weeks. The median number of doses of ZUSDURI administered to patients was 6 (range 1-6) doses and 228 patients (95%) received all six scheduled doses. Serious adve…
Frequently Asked Questions
What is ZUSDURI used for?
ZUSDURI contains Mitomycin. It is a kit taken as directed. Consult your doctor for specific uses.
Is ZUSDURI a controlled substance?
ZUSDURI is not classified as a controlled substance by the DEA.
What is the generic name for ZUSDURI?
The generic name for ZUSDURI is Mitomycin. There are 12 other brand versions of Mitomycin.
What is the NDC code for ZUSDURI ?
The NDC (National Drug Code) for ZUSDURI is 72493-106, listed by UroGen Pharma, Inc.