What Is Zusduri?

Zusduri is a prescription medicine made by UroGen. Its active ingredient is mitomycin, a chemotherapy medicine that has been used in the bladder for many years. In Zusduri, the mitomycin is mixed with a special gel.

The medicine is kept cold so it stays liquid while it goes into your bladder. When it warms up to body temperature, it turns into a soft gel. The gel stays in your bladder and slowly dissolves into your urine over several hours. This keeps the medicine in contact with the bladder lining for a longer time.

Mitomycin works by blocking cancer cells from copying their DNA, so they cannot grow and divide. Because the medicine is placed right into the bladder, very little of it reaches the rest of your body.

FDA Approval

The U.S. Food and Drug Administration (FDA) approved Zusduri in June 2025 for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. This means low-grade tumors on the inside lining of the bladder that have come back after earlier surgery.

Who Is Zusduri For?

Your doctor recommends Zusduri based on your biopsy results, your cystoscopy, and your health history.

Zusduri Is Used For

  • Adults with low-grade bladder cancer that has not grown into the bladder muscle
  • Cancer that has come back after earlier surgery to remove bladder tumors (TURBT)
  • "Intermediate risk" cancer, such as more than one tumor, a tumor larger than 3 cm (about 1¼ inches), or cancer that came back within 1 year

You Should Not Receive Zusduri If You

  • Have a hole or tear in your bladder (perforation)
  • Have had an allergic reaction to mitomycin or any ingredient in Zusduri
  • Have severe kidney disease (your doctor will check this)
  • Are pregnant — Zusduri can harm an unborn baby

How Zusduri Is Given

Zusduri is given in our office by your care team. You do not need to prepare the medicine or take anything home.

The Steps

  • Step 1: A thin, soft tube (catheter) is placed into your bladder, and your urine is drained.
  • Step 2: The cold liquid medicine is gently pushed through the catheter into your bladder.
  • Step 3: The catheter stays in for about 15 minutes, then it is removed.
  • Step 4: You go home the same day and follow the safety steps below.

At-a-Glance

  • Dose: 75 mg of mitomycin (56 mL) each time
  • Schedule: Once a week for 6 weeks
  • Where: In the office, as an outpatient
  • Surgery: None — the medicine is placed through a catheter

Try Not to Miss a Dose

It is important to receive all 6 weekly treatments. If you need to miss an appointment, call our office as soon as possible to reschedule.

How to Prepare

Tell Your Care Team

  • About all your medical conditions, especially kidney problems
  • About all the medicines you take, including over-the-counter medicines, vitamins, and herbal supplements. Bring a list.
  • If you are pregnant, think you may be pregnant, or plan to become pregnant
  • If you are breastfeeding or plan to breastfeed
  • If you have signs of a urinary tract infection, such as burning, fever, or cloudy urine, before a treatment

Pregnancy, Birth Control, and Breastfeeding

  • Women who can become pregnant: you will have a pregnancy test before starting. Use effective birth control during treatment and for 6 months after the last dose.
  • Men with a partner who can become pregnant: use effective birth control during treatment and for 3 months after the last dose.
  • Breastfeeding: do not breastfeed during treatment and for 1 week after the last dose.

Medicines and Fluids

  • Your care team may ask you to take an extra medicine or change how you take a current one during treatment. Ask if you have questions.
  • The Zusduri label does not set a special drinking plan. Follow any instructions your care team gives you about drinking fluids before and after each treatment.

After Each Treatment

The gel slowly dissolves and leaves your body in your urine. Your urine contains the medicine for a while, so follow these steps to protect your skin and the people you live with.

What Is Normal

  • Your urine may turn violet to blue. This is the color of the medicine.
  • You may see bits of gel in your urine. In the main study, people saw gel for a median of about 5 hours and for up to 24 hours.
  • The label does not ask you to hold your urine for a set amount of time. Follow any instructions your care team gives you.

For at Least 24 Hours

  • Avoid getting urine on your skin.
  • Sit down on the toilet to urinate — this applies to both men and women.
  • Flush the toilet several times after each use.
  • After using the bathroom, wash your hands, inner thighs, and genital area well with soap and water.
  • Wash any clothing that gets urine on it right away and separately from other laundry.

Possible Side Effects

Most side effects in the main study were mild to moderate. The most common ones affect how you urinate.

More Common

  • Pain, burning, or trouble urinating (about 1 in 4 people)
  • Urinary tract infection (about 1 in 8 people)
  • Blood in the urine (about 1 in 10 people)
  • Changes seen only on blood tests, such as kidney function, potassium, red or white blood cell counts, and liver tests

Less Common but Important

  • Needing to urinate often or urgently, including at night
  • Tiredness
  • Leaking urine
  • Not being able to empty your bladder (urinary retention)
  • Narrowing of the urine tube (urethral stricture)
  • Pain, swelling, itching, or rash in the genital area
  • Kidney injury

People with moderate kidney problems had more blood in the urine and more urinary tract infections, so your care team may watch you more closely.

Call Our Office Right Away If You Have

  • Trouble urinating or you cannot urinate at all
  • Fever, chills, or burning, cloudy, or bad-smelling urine
  • Heavy bleeding or blood clots in your urine
  • Pain that is severe or keeps getting worse
  • A rash, swelling, or other signs of an allergic reaction
  • A positive pregnancy test or think you may be pregnant

Call 678-344-8900. If you have trouble breathing or another emergency, call 911.

What the Research Shows

Zusduri was studied in the ENVISION trial, which included 240 adults with low-grade intermediate-risk bladder cancer that had come back after earlier surgery.

Outcome Result
No cancer found 3 months after starting treatment 78% of patients (about 8 in 10)
Still cancer-free at least 12 months later 79% of those who responded
Received all 6 doses 95% of patients

Low-grade bladder cancer often comes back, even after successful treatment. That is why regular check-ups are important.

Follow-Up Care

About 3 Months After You Start

  • You will have a cystoscopy — a look inside your bladder with a thin camera — to see how the treatment worked.
  • A urine test (cytology) and, if needed, a small biopsy may also be done.

After That

  • You will have cystoscopies on a regular schedule to watch for cancer coming back. In the main study, they were done every 3 months.
  • If any cancer is found, your doctor will talk with you about next steps.

Insurance and Prior Approval

Most insurance plans need to approve Zusduri before your first treatment. This is called prior authorization. Our office handles this request for you. Approval can take some time, so your first treatment date may depend on when your plan responds. We will contact you if we need anything from you.

Frequently Asked Questions

Is Zusduri the same as the mitomycin I may have had after surgery?

It uses the same medicine, mitomycin. The difference is the gel, which keeps the medicine in your bladder longer, and the schedule of 6 weekly treatments.

Will I need surgery?

Zusduri treats the tumors with medicine instead of removing them with another surgery. If cancer is still there or comes back later, your doctor will discuss other options, which may include surgery.

Why is my urine blue or purple?

Mitomycin is a violet-blue color. It can color your urine after each treatment. This is expected.

What if I miss a treatment?

Call our office as soon as possible to reschedule. Getting all 6 doses is important.

How long do I need to take the bathroom precautions?

For at least 24 hours after each treatment: sit to urinate, flush several times, wash with soap and water, and wash soiled clothing separately.

Questions About Your Zusduri Treatment?

Our team is here to help you through all 6 treatments and your follow-up visits.

  • ✅ Once a week for 6 weeks, in the office
  • ✅ Sit to urinate and flush several times for at least 24 hours
  • ✅ Call us about trouble urinating, fever, or heavy bleeding
  • ✅ Prior approval from your insurance handled by our office
Schedule Your Consultation

Call 678-344-8900 to speak with our team