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Zusduri (Mitomycin): Uses, Side Effects and Dosage

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Prescription (Rx)
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40 mg
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Zusduri

What is ZUSDURI?

ZUSDURI 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.

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

Who should not receive ZUSDURI?

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 Patient Information leaflet 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. 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:

    • 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 is able to become pregnant, 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.

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.

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 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.

What are the possible side effects of ZUSDURI?

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

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.

General information about ZUSDURI.

Medicines are sometimes prescribed for purposes other than those listed in this Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about ZUSDURI that is written for healthcare professionals.

What are the ingredients of ZUSDURI?

Active ingredient: mitomycin

Inactive ingredients: hydroxypropyl methylcellulose, mannitol, poloxamer, polyethylene glycol, and water for injection

Distributed by: UroGen Pharma, Inc., Princeton, NJ 08540

ZUSDURI™ is a trademark and UroGen® is a registered trademark of UroGen Pharma, Ltd.

U.S. Patent Nos. 9,040,074, 9,950,069 and 10,039,832

Copyright© 2025 UroGen Pharma, Inc.

All rights reserved.

For more information go to www.ZUSDURI.com or call 1-855-987-6436.

ZUS-PPI-001

INSTRUCTIONS FOR PHARMACY (IFP)

ZUSDURI™ (zus-dur-ee)

(mitomycin) for intravesical solution

Purpose of this Instructions for Pharmacy

This Instructions for Pharmacy contains information on how to prepare ZUSDURI using pharmacy supplies and a Chilling Block or other means of chilling.

Intended Use of ZUSDURI

ZUSDURI (mitomycin) for intravesical solution is indicated for the treatment of adult patients with recurrent low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

Important Information You Need to Know Before Reconstituting ZUSDURI

Reconstituted ZUSDURI must be prepared under chilled conditions. ZUSDURI cannot be prepared without a Chilling Block or other means of chilling.

Once reconstituted with sterile hydrogel, ZUSDURI will appear as a semisolid gel under room temperature conditions and as a viscous liquid under chilled conditions.

Preparation of ZUSDURI must be performed under aseptic conditions.

Storage Conditions and Handling

Before reconstitution, store ZUSDURI at room temperature, 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C and 30°C (59°F and 86°F). Avoid excessive heat over 40°C (104°F). Protect from light.

Storage Instructions for Reconstituted ZUSDURI:

  • Instill reconstituted ZUSDURI as soon as possible.

  • If not used immediately, store reconstituted ZUSDURI:

    • under refrigeration at 2℃ to 8℃ (36°F to 46°F) for up to 7 days; or
    • under refrigeration at 2℃ to 8℃ (36°F to 46°F) for up to 6 days followed by no more than 24 hours at room temperature, 20°C to 25°C (68°F to 77°F).
  • Discard 7 days after reconstitution.
  • Protect from light.
  • Avoid excessive heat over 40°C (104°F).

ZUSDURI is a hazardous drug. Procedures for Proper Handling and Disposal of hazardous drugs should be followed.

Supplies Needed

ZUSDURI available in a kit containing:

  • Two vials of ZUSDURI, 40 mg per vial
  • One vial of Sterile hydrogel, 60 mL
  • One ZUSDURI admixture label
  • ZUSDURI Prescribing Information (PI)
  • ZUSDURI Instructions for Pharmacy (IFP)
  • ZUSDURI Instructions for Administration (IFA)

Pharmacy Supplies:

(Provided by your facility)

Do not substitute any of these components
Two 20 mL Luer lock syringes
Two 5 mL Luer lock syringes filled with 3 mL sterile water
Three OnGuard®2 CSTD vial adaptors
Four OnGuard®2 CSTD syringe adaptors

Chilling Block or other means of chilling (device design may vary)

Note: The day before the preparation, place the Chilling Block in the freezer at -20°C to -12°C (-4°F to 10.4°F). Refer to the Chilling Block Instructions for Use for more information.

Steps to Prepare ZUSDURI Admixture

  1. A.

    Freeze the Chilling Block

    1. 1.

      The day before preparation, put the Chilling Block in the freezer at -20°C to -12°C (-4°F to 10.4°F).

      Note: Please refer to the Chilling Block Instructions for Use for additional information.

  1. B.

    Prepare Supplies

    1. 1. Remove the Chilling Block from the freezer.
    2. 2. Disinfect the Chilling Block as per your pharmacy's policy. Allow it to air dry, and then place it inside the hood or isolator.
    3. 3. Connect vial adaptors to all three vials.
    4. 4. Connect syringe adaptors to both empty 20 mL syringes and both sterile water syringes.
    5. 5.

      Place one ZUSDURI vial, the sterile hydrogel vial, and both empty 20 mL syringes in the Chilling Block for approximately 20 minutes.

      Note: The Chilling Block has five compartments, but only four are needed. The small vial compartment will not be used during this preparation.

  1. 6. Set the second ZUSDURI vial and both sterile water syringes aside for later use.
  1. C.

    Reconstitute the First ZUSDURI Vial

    1. 1. Slowly fill one chilled 20 mL syringe with 14 mL of sterile hydrogel.
    2. 2. Slowly fill the other chilled 20 mL syringe with 13 mL of sterile hydrogel.
    3. 3. Place both 20 mL syringes and the sterile hydrogel vial back in the Chilling Block.
    4. 4. Remove the chilled ZUSDURI vial from the Chilling Block.
    5. 5. Inject 3 mL of sterile water into the ZUSDURI vial.
    6. 6.

      Gently swirl the ZUSDURI vial upright at least 20 times.

      Note: Do not invert or shake the vial.

    7. 7. Inject the chilled 14 mL and 13 mL syringes of sterile hydrogel into the ZUSDURI vial.
    8. 8. Place both empty 20 mL syringes back in the Chilling Block for later use.
    9. 9.

      Vigorously swirl the ZUSDURI vial upright for about 2 minutes.

      Note: Do not invert or shake the vial.

    10. 10. Set the first ZUSDURI vial aside for later use.
  1. D.

    Reconstitute the Second ZUSDURI Vial

    1. 1. Place the second ZUSDURI vial in the Chilling Block.
    2. 2. Slowly fill one chilled 20 mL syringe with 14 mL of sterile hydrogel.
    3. 3. Slowly fill the other chilled 20 mL syringe with 13 mL of sterile hydrogel.
    4. 4. Place both 20 mL syringes back in the Chilling Block.
    5. 5. Discard the empty sterile hydrogel vial.
    6. 6. Remove the chilled ZUSDURI Vial from the Chilling Block.
    7. 7. Inject 3 mL of sterile water into the ZUSDURI vial.
    8. 8.

      Gently swirl the ZUSDURI vial upright at least 20 times.

      Note: Do not invert or shake the vial.

    9. 9. Inject the chilled 14 mL and 13 mL syringes of sterile hydrogel into the ZUSDURI vial.
    10. 10. Place both empty 20 mL syringes back in the Chilling Block for later use.
    11. 11.

      Vigorously swirl the ZUSDURI vial upright for about 2 minutes.

      Note: Do not invert or shake the vial.

  1. E.

    Combine the Contents of the ZUSDURI Admixture Vials

    1. 1.

      Slowly fill each chilled 20 mL syringe with 14 mL of admixture from the second ZUSDURI vial (for a total of 28 mL).

      Note: If you are having difficulty withdrawing the admixture, place the components back in the Chilling Block until the admixture liquifies again.

    2. 2. Inject the two 14 mL admixture syringes into the first ZUSDURI vial.
    3. 3. You now have one vial that contains ZUSDURI admixture.
  1. F.

    Dispense Reconstituted ZUSDURI

    1. 1.

      Write the "Discard after" date and time on the supplied admixture label and apply to the prepared ZUSDURI admixture vial. You may also substitute your pharmacy's label for dispensing the ZUSDURI admixture.

      Note: The "Discard after" date and time is 7 days from the completion of the preparation. Store reconstituted ZUSDURI at 2°C to 8°C (36°F to 46°F) for up to 7 days. Alternatively, reconstituted ZUSDURI may be stored under refrigeration at 2℃ to 8℃ (36°F to 46°F) for up to 6 days followed by no more than 24 hours at room temperature, 20°C to 25°C (68°F to 77°F). Avoid excessive heat over 40°C (104°F). Protect from light.

    2. 2.

      Transport the following items to the treatment facility:

      1. i. One reconstituted ZUSDURI vial.
      2. ii. ZUSDURI Instructions for Administration (IFA).

Important to Remember

  • All components need to be kept cold during the preparation process by placing them in the Chilling Block or other means of chilling when they are not in use.
  • If you are having difficulty pushing or withdrawing the solution at any time, place the components back in the Chilling Block or other means of chilling until the product liquifies again.

Frequently Asked Questions

This Instructions for Pharmacy has been approved by the U.S. Food and Drug Administration.

How do I connect the vial adaptor?

Place the vial adaptor over the vial and press down firmly. You will hear a snap which confirms successful attachment.

How do I connect the syringe adaptor?

Screw the Luer lock end of the syringe adaptor onto the syringe hub until it is finger tight.

How do I connect the syringe adaptor to the vial adaptor?

Place the syringe adaptor over the vial adaptor and align the tabs, then press down firmly. You will hear a snap which confirms successful attachment.

How do I disconnect the syringe adaptor from the vial adaptor?

Pinch the tabs on the syringe adaptor to separate it from the vial adaptor.

Do I have to keep the vials upright when mixing?

If so, why?

Yes, the vials should be kept upright when mixing to ensure the contents are fully mixed at the bottom of the vial.

I am having difficulty working with the drug product. It seems to be solidifying.

If you are having difficulty pushing or withdrawing the solution, place the components back in the Chilling Block or other means of chilling until it liquifies.

INSTRUCTIONS FOR ADMINISTRATION (IFA)

ZUSDURI™ (zus-dur-ee)

(mitomycin) for intravesical solution

For Intravesical Instillation Only

Read and follow this Instructions for Administration prior to each ZUSDURI instillation.

Purpose of this Instructions for Administration

This Instructions for Administration contains information on how to instill ZUSDURI using the ZUSDURI vial and the devices listed under Supplies Needed, obtained by your facility.

Intended Use of ZUSDURI

ZUSDURI (mitomycin) for intravesical solution is indicated for the treatment of adult patients with recurrent low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

Important Information You Need to Know Before Instilling ZUSDURI

ZUSDURI must be reconstituted by a healthcare professional prior to instillation. Reconstituted ZUSDURI will appear as a semisolid gel. Once chilled, ZUSDURI will convert to a viscous liquid for instillation.

Once instilled into the patient's bladder, ZUSDURI will convert to a semisolid gel, thereby exposing the lining of the bladder to mitomycin over a prolonged period of time.

Storage Instructions for Reconstituted ZUSDURI:

  • Instill reconstituted ZUSDURI as soon as possible.

  • If not used immediately, store reconstituted ZUSDURI:

    • under refrigeration at 2℃ to 8℃ (36°F to 46°F) for up to 7 days; or
    • under refrigeration at 2℃ to 8℃ (36°F to 46°F) for up to 6 days followed by no more than 24 hours at room temperature, 20°C to 25°C (68°F to 77°F).
  • Discard 7 days after reconstitution.
  • Protect from light.
  • Avoid excessive heat over 40°C (104°F).

When ready to instill, chill ZUSDURI at -3°C to 5°C (27°F to 41°F) for about 20 minutes to revert it to a viscous liquid. See Steps A through C below for complete administration instructions.

ZUSDURI is a hazardous drug. Procedures for proper handling and disposal of hazardous drugs should be followed, as described below.

Supplies Needed

One vial of reconstituted ZUSDURI, with resultant concentration of 80 mg per 60 mL.

(prepared and provided by your pharmacy)

Ice Bath

Note: The ice bath should consist of ice and cold water and be large enough to submerge a ZUSDURI vial.

Plastic Bag

Ancillary Supplies

When you administer ZUSDURI, you will need to use special adaptors for your catheter and syringes. These adaptors will create a closed pathway to protect you and your patient during and after administration. Fluid will only be able to pass between connection points when the adaptors are fully engaged, preventing drips or leaks.

Once the adaptors are connected, do not disconnect them. They are there for your protection.

Urinary Catheter

One 12 Fr to 16 Fr with fixed Luer lock connector

Do not substitute

Catheter Adaptor

One OnGuard®2 CSTD Luer lock adaptor

Do not substitute

Administration Syringes

Four 20 mL polypropylene Luer lock syringes (BD Luer-Lok™ Syringe)

Do not substitute

Sterile Water Flush

One 5 mL Luer lock syringe filled with 3 mL sterile water

Syringe Adaptors

Five OnGuard®2 CSTD syringe adaptors

Do not substitute

Instillation Instructions

  1. A.

    Chill the ZUSDURI

    1. 1. Place the ZUSDURI vial in a plastic bag.
    2. 2.

      Place the plastic bag in the ice bath for approximately 20 minutes.

      Note: Ensure the ZUSDURI vial is completely immersed in the ice bath.

  2. B.

    Prepare the Four Administration Syringes

    1. 1. Connect a syringe adaptor to the 3 mL sterile water syringe and set aside.
    2. 2.

      Connect syringe adaptors to the four 20 mL syringes. These will be the administration syringes.

      Note: Once the adaptors are connected, do not disconnect them. They are there for your protection.

    3. 3. Remove the ZUSDURI vial from the ice bath and verify the admixture is liquid. If the admixture is not liquid, place the vial bag back into the ice bath until the admixture liquefies.
    4. 4. Swirl the vial upright to ensure that ZUSDURI is uniformly mixed.
    5. 5.

      Slowly fill each of the four administration syringes with 14 mL of ZUSDURI admixture (for a total of 56 mL).

      Note: there might be foaming in the syringe while withdrawing ZUSDURI.

    6. 6. Place the four administration syringes in the plastic bag.
    7. 7.

      Place the plastic bag in the ice bath, ensuring the four administration syringes are completely immersed, for at least two minutes.

  3. C.

    Instill ZUSDURI

    The contents of four administration syringes must be instilled in rapid succession without delay to avoid ZUSDURI solidification. Before proceeding:

    • Ensure that all four administration syringes contain liquid ZUSDURI.
    • Keep all four administration syringes chilled in the ice bath until instillation time.
    1. 1. Place the urinary catheter in the bladder and drain the urine.
    2. 2. Connect the catheter adaptor to the urinary catheter.
    3. 3. Connect an administration syringe to the urinary catheter.
    4. 4.

      Instill the ZUSDURI into the patient.

      Note: Empty each administration syringe over approximately 30 seconds. ZUSDURI is viscous, even in a chilled state.

    5. 5. Disconnect the syringe adaptor from the catheter adaptor.
    6. 6. Immediately repeat these steps without delay for the remaining three administration syringes.
    7. 7. After all four administration syringes have been instilled, flush the urinary catheter with 3 mL of sterile water.
    8. 8.

      Wait 15 minutes before removing the urinary catheter from the patient.

    9. 9. Discard all ancillary supplies according to your facility's procedures for hazardous waste.

Frequently Asked Questions

How do I connect the syringe adaptor?

Screw the Luer lock end of the syringe adaptor onto the syringe hub until it is finger tight.

How do I connect the syringe adaptor to the vial adaptor?

Place the syringe adaptor over the vial adaptor and align the tabs; then press down firmly. You will hear a snap which confirms successful attachment.

How do I disconnect the syringe adaptor from the vial adaptor?

Pinch the tabs on the syringe adaptor to separate it from the vial adaptor.

I am having a hard time working with ZUSDURI. It seems to be solidifying.

If you are having difficulty pushing or withdrawing ZUSDURI, recap and place the components back into the ice bath until ZUSDURI liquifies. The vial may be placed upside down within the bag in the ice bath.

How do I connect the catheter adaptor to the urinary catheter?

Screw the Luer lock end of the catheter adaptor onto the urinary catheter connector until it is finger tight.

How do I connect the syringe adaptor to the catheter adaptor?

Place the syringe adaptor in front of the catheter adaptor and push it on firmly. You will hear a snap which confirms successful attachment.

How do I disconnect the syringe adaptor from the catheter adaptor?

While holding the urinary catheter steady and fixed in its position, pinch the tabs on the syringe adaptor to separate it from the catheter adaptor.

This "Instructions for Administration" has been approved by the U.S. Food and Drug Administration.

Distributed by:

UroGen Pharma, Inc.

Princeton, NJ 08540

www.ZUSDURI.com

ZUSDURI™ is a trademark of UroGen Pharma, Ltd.

OnGuard® is a registered trademark of Simplivia Healthcare Ltd.

BD Luer-Lok™ is a trademark of Becton, Dickinson and Company.

Copyright© 2025 UroGen Pharma, Inc.

All rights reserved.

ZUS-IFA-001

IFA-0017644/Ver. 1

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 215793 · View the label on DailyMed

Revision date stated in the text: June 2025

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Zusduri

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Alkylating Drug
Active ingredient Mitomycin 40 mg
Dosage form Kit
Marketing status listed in the FDA NDC Directory
Company (applicant) UROGEN PHARMA
FDA approval NDA 215793New Drug Application (NDA) Approved June 12, 2025
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
40 mg – 1 in 1 carton NDC 72493-106-03

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.