With ZUSDURI, 78% of patients had no detectable cancer at 3 months and 79% of those patients remained tumor-free 12 months later

The ZUSDURI clinical trial studied 223 patients with recurrent LG-IR-NMIBC. They received ZUSDURI once a week for 6 weeks. The results are as follows:

78^%

of patients

had no detectable tumor at 3 months

after treatment with ZUSDURI(No detectable tumor is also called a complete response or CR)

79^%

of patients who had no detectable tumor at 3 months were

still tumor-free 12 months later

ZUSDURI side effects

Most side effects in the ZUSDURI trial were mild-to-moderate, but serious side effects may occur.

The most common side effects of ZUSDURI include:

Increased blood creatinine levels
Increased blood potassium levels
Trouble with urination
Decreased red blood cell counts

Increase in certain blood liver tests
Increased or decreased white blood cell counts
Urinary tract infection
Blood in your urine

Serious side effects occurred in 12% of patients who received ZUSDURI, including 2 with urinary retention (unable to fully empty the bladder) and 1 with urethral stenosis (narrowing of the tube that carries urine out of the body).

You should not receive ZUSDURI if you have a hole or tear (perforation) of your bladder or if you have had an allergic reaction to mitomycin or to any of the ingredients in ZUSDURI.

Before receiving ZUSDURI, tell your healthcare provider about all of your medical conditions, including if you have kidney problems, are pregnant, or plan to become pregnant. ZUSDURI can harm your unborn baby. You should not become pregnant during treatment with ZUSDURI. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ZUSDURI.

See additional IMPORTANT SAFETY INFORMATION below.

Talk to your doctor today about the benefits of ZUSDURI

LG-IR-NMIBC=low-grade intermediate-risk non-muscle invasive bladder cancer.
*Compensated for her time.
^†The ZUSDURI trial is an ongoing phase 3 trial that follows patients for 5 years.

APPROVED USE FOR ZUSDURI

ZUSDURI (mitomycin) for intravesical solution is a prescription medicine used to treat adults with a type of cancer of the lining of the bladder called low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) after you have previously received bladder surgery to remove tumor and it did not work or is no longer working.

IMPORTANT SAFETY INFORMATION

You should not receive ZUSDURI if you have a hole or tear (perforation) of your bladder or if you have had an allergic reaction to mitomycin or to any of the ingredients in ZUSDURI.

Before receiving ZUSDURI, tell your healthcare provider about all of your medical conditions, including if you:

have kidney problems
are pregnant or plan to become pregnant. ZUSDURI can harm your unborn baby. You should not become pregnant during treatment with ZUSDURI. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ZUSDURI.
Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with ZUSDURI and for 6 months after the last dose.
Males being treated with ZUSDURI: You should use effective birth control (contraception) during treatment with ZUSDURI and for 3 months after the last dose.
are breastfeeding or plan to breastfeed. It is not known if ZUSDURI passes into your breast milk. Do not breastfeed during treatment with ZUSDURI and for 1 week after the last dose.

How will I receive ZUSDURI?

You will receive your ZUSDURI dose from your healthcare provider 1 time a week for 6 weeks into your bladder through a tube called a urinary catheter. It is important that you receive all 6 doses of ZUSDURI according to your healthcare provider’s instructions.

If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

During treatment with ZUSDURI, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.

After receiving ZUSDURI:

ZUSDURI may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 24 hours.

To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.

Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.

The most common side effects of ZUSDURI include: increased blood creatinine levels, increased blood potassium levels, trouble with urination, decreased red blood cell counts, increase in certain blood liver tests, increased or decreased white blood cell counts, urinary tract infection, blood in your urine.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.

ZUSDURI:Powerful results that last