Zusduri® (Mitomycin Intravesical Solution) Bladder Cancer Treatment

What it is

Zusduri is a treatment for adult patients whose bladder cancer is non-muscle invasive, low grade, intermediate risk, and has recurred after prior surgery to remove the tumor (transurethral resection). It is the first therapy approved specifically for this group of patients.

How it works

Zusduri contains mitomycin, a chemotherapy drug, in a special hydrogel delivery formulation. The medication is placed directly into the bladder via a urinary catheter. The hydrogel allows the drug to remain in contact with the bladder lining for an extended period, helping to destroy cancer cells locally.

Who is a candidate

Adults with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer after prior tumor removal may be eligible.
Zusduri is not intended for muscle-invasive or high-grade disease unless otherwise directed by your specialist.
It should not be used if your bladder is perforated or the bladder lining is compromised.

How it is given

The usual regimen is one instillation of Zusduri 75 mg (in 56 mL solution) once weekly for six consecutive weeks. The medication is delivered into the bladder through a urinary catheter in an outpatient setting. After each treatment, you will urinate to remove the gel and solution. Your urine may appear violet or blue, which is normal.

Before treatment, discuss with your doctor

The condition of your bladder, to ensure there is no perforation or mucosal injury.

• Your kidney, liver, and blood test results, as mitomycin may affect these organs.
• Whether you are pregnant, breastfeeding, or may become pregnant.
  • Women who can become pregnant should use effective contraception during treatment and for six months after the last dose.
  • Men with partners who can become pregnant should use contraception during treatment and for three months after the last dose.
• Any allergies to mitomycin or related medications.

After each treatment

• Sit to urinate to reduce splashing and minimize skin contact.
• Flush the toilet several times after use.
• Wash your hands, inner thighs, and genital area with soap and water after urinating.
• Wash any clothing or linens that come into contact with urine immediately and separately from other laundry.

Possible side effects

Common effects may include:

• Pain or burning during urination
• Blood in the urine
• Urinary tract infection
• Mild fatigue or changes in blood counts
• Temporary increase in creatinine or potassium levels
  Serious but uncommon reactions include urinary retention, severe bladder pain, or allergic reactions.

When to call your doctor

Contact your healthcare provider immediately if you have:

• Severe or worsening difficulty urinating
• High fever, persistent bleeding, or severe pain
• Signs of allergic reaction such as rash, swelling, or trouble breathing
• Any concerning or unexpected side effects

Follow-up and monitoring

After treatment, you will have periodic cystoscopies, urine cytology, and possibly biopsies to check for recurrence. Because Zusduri is a new therapy (FDA approval June 2025), your urologist will discuss ongoing monitoring and long-term results as more data become available.

Benefits and limitations

In clinical trials, approximately 78% of patients achieved a complete response (no detectable cancer) at three months after treatment, and about 79% of those responders remained disease-free at 12 months. The trial was not randomized, and long-term outcomes are still being studied. Zusduri may reduce the need for repeat surgeries in recurrent bladder cancer, but it does not guarantee the cancer will not return.

Your role in the treatment plan

• Attend all scheduled weekly treatments.
• Follow pre- and post-treatment instructions carefully.
• Report any symptoms or side effects promptly.
• Maintain follow-up visits and regular monitoring as recommended by your urologist.

Important note

This handout is for patient education only and is not a substitute for professional medical advice. Each patient’s situation is unique. Your urologist or oncologist will determine whether Zusduri is appropriate for you and tailor treatment accordingly.

References

FDA. (2025). Mitomycin intravesical solution approval for recurrent NMIBC.
JADPRO. (2025). ZUSDURI for recurrent low-grade bladder cancer.
Drugs.com. (2025). Zusduri: Uses and side effects.
AACR. (2025). New intravesical therapy for bladder cancer.
Renal & Urology News. (2025). FDA approves ZUSDURI for recurrent NMIBC.
UroGen Pharma. (2025). Patient information: ZUSDURI.com.

Zusduri, mitomycin, bladder cancer, bladder cancer treatment, BCG, bladder cancer instillation, cancer of the bladder