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Zusduri

mitomycin intravesical
Alkylating Agent (Intravesical)FDA Approved 2025UroGen Pharma
Route
IV
Half-Life
~14 hrs
FDA Approved
2025
Manufacturer
UroGen Pharma
1. Indications and Usage

Adults with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer.

2. Dosage and Administration

40 mg/20 mL intravesical instillation weekly for 6 weeks (induction), then monthly for up to 11 additional instillations.

3. Dosage Forms and Strengths

Intravesical solution: 40 mg/20 mL reverse thermal gel

4. Contraindications

Bladder perforation. Active urinary tract infection.

5. Warnings and Precautions
  • Bladder Perforation: Do not administer if perforation suspected.
  • UTI: Treat infections before instillation.
  • Myelosuppression: Systemic absorption possible.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Dysuria (45%), Hematuria (38%), Urinary Frequency (32%), UTI (28%), Bladder Spasm (22%), Fatigue (18%), Pelvic Pain (14%)

Dysuria
45%
Hematuria
38%
Urinary Frequency
32%
UTI
28%
Bladder Spasm
22%
Fatigue
18%
Pelvic Pain
14%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

No formal drug interaction studies. Systemic absorption minimal.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Mitomycin is an alkylating agent that cross-links DNA. The reverse-thermal hydrogel formulation enables sustained intravesical drug exposure by converting from liquid to gel at body temperature.

Pharmacokinetics

Administered locally. Systemic exposure minimal. Gel provides sustained local release.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Mitomycin Intravesical Trials on ClinicalTrials.gov ↗ 📚 PubMed: Mitomycin Intravesical Clinical Trials ↗
FDA-Approved Tumor Types

Zusduri has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Bladder Cancer
External Resources
📋 DailyMed Label ↗🏛️ FDA Drugs@FDA ↗🔬 ClinicalTrials.gov ↗📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Zusduri. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Zusduri (mitomycin intravesical) approved for?

Zusduri (mitomycin intravesical) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Zusduri (mitomycin intravesical) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Zusduri (mitomycin intravesical) work?

Mitomycin is an alkylating agent that cross-links DNA. The reverse-thermal hydrogel formulation enables sustained intravesical drug exposure by converting from liquid to gel at body temperature.

What are the most common side effects?

Dysuria (45%), Hematuria (38%), Urinary Frequency (32%), UTI (28%), Bladder Spasm (22%), Fatigue (18%), Pelvic Pain (14%) Dysuria 45% Hematuria 38% Urinary Frequency 32% UTI 28% Bladder Spasm 22% Fatigue 18% Pelvic Pain 14%

← All TherapiesFull Prescribing Information ↗