Zusduri

Pronunciation: zus-dur-ee
Generic name: mitomycin
Brand name: Zusduri
Dosage form: kit for intravesical solution (contains two 40 mg single dose vials of mitomycin and one 40 mL vial of sterile hydrogel)
Drug class: Antibiotics / antineoplastics

Medically reviewed by Carmen Pope, BPharm. Last updated on Jun 16, 2025.

What is Zusduri?

Zusduri is used to treat recurrent low-grade, intermediate-risk, non-muscle invasive bladder cancer (LG-IR-NMIBC), in adults who have previously received bladder surgery to remove the tumor, and it did not work or is no longer working. It is given via a urinary catheter into your bladder once a week for six weeks.

Zusduri works by stopping cancer cells from making deoxyribonucleic acid (DNA), which they need to grow and divide. Its mechanism involves creating links between parts of the DNA molecule, and at high doses, it also stops cells from making other important molecules such as RNA and proteins. Zusduri belongs to the drug class called alkylating drugs

When placed directly into the bladder, Zusduri targets the cancer locally, killing any remaining cancer cells after surgery, with fewer effects on the rest of the body.

Zusduri (mitomycin) gained FDA approval on June 12, 2025. Mitomycin has been approved since 1981.

Side effects

The most common side effects of Zusduri are:

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 and warnings

Zusduri may cause the following serious side effects:

Risks in patients with a perforated bladder. Zusduri may spread throughout the body if given to those with or in those in whom the integrity of the bladder mucosa has been compromised, leading to body-wide exposure to mitomycin. Your healthcare provider will evaluate your bladder before instilling Zusduri. It should not be administered to patients with a perforated bladder or in whom the integrity of the bladder mucosa has been compromised.
Harm to an unborn baby. Zusduri can cause fetal harm. Your healthcare provider will advise you of the potential risk to an unborn baby and to use effective contraception.
Allergic reactions. Do not receive Zusduri if you are allergic to mitomycin, Zusduri, or any components of the solution for intravesical use.

It is not known if Zusduri is safe and effective for use in children.

Call your doctor for medical advice about possible side effects. You may report side effects to FDA at 1-800-FDA-1088. You can also report side effects to UroGen Pharma at 1-855-987-6436.

Before taking

Do not receive Zusduri if you:

have a hole or tear (perforation) of your bladder,
have had an allergic reaction to mitomycin or to any of the ingredients in Zusduri. See the end of this guide for a complete list 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
are breastfeeding or plan to breastfeed.

Pregnancy

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 can become pregnant:

Your healthcare provider will check to see if you are pregnant before starting treatment with Zusduri.
You should use effective birth control (contraception) during treatment with Zusduri and for 6 months after the last dose.
Talk to your healthcare provider if you have questions about birth control options that are right for you.

Males being treated with Zusduri:

If you have a female partner who can become pregnant, you should use effective birth control (contraception) during treatment with Zusduri and for 3 months after the last dose.

Breastfeeding

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?

Zusduri will be given to you by your healthcare provider.

You will receive Zusduri 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. Ask your healthcare provider if you have any questions.

After receiving Zusduri

Zusduri may cause your urine color to change from yellow to violet or blue.
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 they use it.

After going to the bathroom, wash your hands, your inner thighs, and the 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.

What other drugs will affect Zusduri?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.