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Jelmyto (Mitomycin): Uses, Side Effects and Dosage

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Status:
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 - Jelmyto

What is JELMYTO?

JELMYTO is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).

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

Who should not receive JELMYTO?

Do not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.

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

  • are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby. You should not become pregnant during treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO.

    Females who are able to become pregnant:

    • Your healthcare provider will check to see if you are pregnant before starting treatment with JELMYTO.
    • You should use effective birth control (contraception) during treatment with JELMYTO 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 JELMYTO:

    • If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose.
  • are breastfeeding or plan to breastfeed. It is not known if JELMYTO passes into your breast milk. Do not breastfeed during treatment with JELMYTO 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.

Especially tell your healthcare provider if you take water pills (diuretic).

How will I receive JELMYTO?

  • Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO treatment. Your healthcare provider will provide instructions about how and when to take sodium bicarbonate.
  • JELMYTO will be given to you by your healthcare provider.
  • You will receive JELMYTO 1 time a week for 6 weeks. It is important that you receive all 6 doses of JELMYTO according to your healthcare provider's instructions. Your healthcare provider may recommend up to an additional 11 monthly doses.
  • If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
  • JELMYTO is given to your kidney through a tube called a catheter.
  • During treatment with JELMYTO, 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 JELMYTO:

  • JELMYTO may cause your urine color to change to a violet to blue color.
  • Avoid contact between your skin and urine for at least 6 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 JELMYTO?

JELMYTO may cause serious side effects, including:

  • Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction). If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain. Tell your healthcare provider right away if you develop side pain or fever during treatment with JELMYTO.
  • Bone marrow problems. JELMYTO can affect your bone marrow and can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with JELMYTO. Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO.

The most common side effects of JELMYTO include:

  • urinary tract infection
  • blood in your urine
  • side pain
  • nausea
  • trouble with urination
  • kidney problems
  • vomiting
  • tiredness
  • stomach (abdomen) pain

Call your doctor for medical advice about 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 JELMYTO.

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 JELMYTO that is written for healthcare professionals.

What are the ingredients of JELMYTO?

Active ingredient: mitomycin

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

Distributed by:

UroGen Pharma, Inc.

Princeton, NJ 08540

JELMYTO® and UroGen® are registered trademarks of UroGen Pharma, Ltd.

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

Copyright© 2022 UroGen Pharma, Inc.

All rights reserved.

JEL-PPI-003

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

INSTRUCTIONS FOR PHARMACY (IFP)

JELMYTO® (jel-MYE-toe)

(mitomycin) for pyelocalyceal solution

Purpose of this Instructions for Pharmacy

This Instructions for Pharmacy contains information on how to prepare JELMYTO using pharmacy supplies and a Chilling Block.

Intended Use of JELMYTO

JELMYTO (mitomycin) for pyelocalyceal solution is indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC).

Important Information You Need to Know Before Reconstituting JELMYTO

Once reconstituted with sterile hydrogel, JELMYTO will appear as a semisolid gel. Once chilled, JELMYTO will convert to a viscous liquid.

Reconstituted JELMYTO must be prepared under chilled conditions. A Chilling Block can be used for this purpose. JELMYTO cannot be prepared without the Chilling Block or other means of chilling.

Preparation of JELMYTO must be performed under aseptic conditions.

Storage Conditions and Handling

Instill the JELMYTO solution as soon as possible after reconstitution. Store reconstituted JELMYTO at 20°C to 25°C (68°F to 77°F) for up to 96 hours (4 days). Protect from light.

JELMYTO is a cytotoxic anti-cancer drug. Procedures for Proper Handling and Disposal of anti-cancer drugs should be followed.

Supplies Needed:

JELMYTO Kit containing:

  • 2 Vials of Mitomycin for Pyelocalyceal Solution, 40 mg/vial
  • 1 Vial Sterile Hydrogel, 20 mL/vial
  • 1 JELMYTO Admixture Label
  • JELMYTO Full Prescribing Information (PI)
  • JELMYTO Instructions for Pharmacy (IFP)
  • JELMYTO Instructions for Administration (IFA)

Pharmacy Supplies

(Provided by Your Facility)

Do not substitute any of these components.

  • 3 × TEVADAPTOR® or OnGuard®2 CSTD Vial Adaptors
  • 3 × TEVADAPTOR® or OnGuard®2 CSTD Syringe Adaptors
  • 1 × Luer Lock connector
  • 2 × 10 mL Luer Lock syringes
  • 1 × 20 mL Luer Lock syringe
  • 1 × 20-25G needle (for drawing up sterile water)
  • 2 mL sterile water
  • 70% Isopropyl alcohol or equivalent
  • 1 × Light protective bag
  • 1 × Chilling Block (device design may vary)

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

Steps to Prepare JELMYTO Admixture

  1. A.

    Freeze Chilling Block

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

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

  2. B.

    Prepare Supplies

    1. 1. Remove the Chilling Block from the freezer.
    2. 2. Disinfect the Chilling Block with 70% Isopropyl alcohol or equivalent, as per your pharmacy's policy. Allow it to air dry, and then place it upright inside the hood or isolator.
    3. 3. Wait 20 minutes before continuing.
    4. 4. Connect vial adaptors to all three vials.
    5. 5. Connect a syringe adaptor to one of the 10 mL syringes.
    6. 6. Connect a syringe adaptor to the 20 mL syringe.
    7. 7. Place the three vials, the 10 mL syringe, and the 20 mL syringe into the Chilling Block for at least 10 minutes.
    8. 8. While the vials and syringes are in the Chilling Block, withdraw 2 mL of sterile water into the other 10 mL syringe and set aside for later use.
  3. C.

    Create Pre-Wetting Solution (PWS)

    1. 1. Slowly fill the chilled 20 mL syringe with 14 mL of sterile hydrogel.
    2. 2. Recap the chilled 20 mL syringe and place it in the Chilling Block.
    3. 3. Slowly fill the chilled 10 mL syringe with 4 mL of sterile hydrogel.
    4. 4. Discard the unused portion of sterile hydrogel.
    5. 5. Replace the needle on 2 mL sterile water syringe with the Luer Lock connector.
    6. 6. Remove the syringe adaptor from the 4 mL sterile hydrogel syringe.
    7. 7. Connect the 4 mL sterile hydrogel syringe to the other side of the Luer Lock connector on the 2 mL sterile water syringe.
    8. 8. Gently mix the sterile water with the sterile hydrogel by pushing the plungers back and forth at least 25 times to create the "pre-wetting solution" (PWS).
    9. 9. Transfer the 6 mL PWS into one of the syringes.
    10. 10. Replace the Luer Lock connector on the 6 mL PWS syringe with a new syringe adaptor.
    11. 11. Place the 6 mL PWS syringe in the Chilling Block.
  4. D.

    Mix the Admixture

    1. 1. Remove both JELMYTO vials from the Chilling Block.
    2. 2. Gently tap the bottom of each vial on the table to ensure all the mitomycin powder is at the bottom of the vials.
    3. 3. Remove the chilled 6 mL PWS syringe from the Chilling Block.
    4. 4.

      Inject 3 mL of PWS into each JELMYTO vial.

      Note: To ensure accurate dosing, the contents of each vial must be the same.

    5. 5. Discard the empty PWS syringe.
    6. 6.

      Gently swirl each JELMYTO vial upright at least 15 times, ensuring all powder and admixture is contained at the bottom of the vial.

      Note: Do not invert or shake the vials.

    7. 7. Immediately remove the chilled 14 mL sterile hydrogel syringe from the Chilling Block.
    8. 8.

      Immediately inject 7 mL of sterile hydrogel into each JELMYTO vial.

      Note: To ensure accurate dosing, the contents of each vial must be the same.

    9. 9.

      Gently swirl each JELMYTO vial upright at least 15 times, ensuring all admixture is contained at the bottom of the vial.

      Note: Do not invert or shake the vials.

    10. 10. Recap and place the 20 mL syringe in the Chilling Block.
    11. 11.

      Mix the JELMYTO admixture vials:

      • Recap and place both JELMYTO vials in the Chilling Block for five minutes.
      • Remove both vials and vigorously swirl them upright at least 15 times, ensuring all admixture is contained at the bottom of the vials.
      • Place both vials back in the Chilling Block.
      • Repeat these steps every five minutes for a total of 30 minutes.

      Note: Do not invert or shake the vials.

  5. E.

    Prepare Admixture Vial

    1. 1. Remove one JELMYTO vial from the Chilling Block.
    2. 2.

      Vigorously swirl the vial upright at least 15 times.

      Note: Do not invert or shake the vial.

    3. 3.

      Using the chilled 20 mL syringe, slowly withdraw 7 mL of admixture from the vial.

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

    4. 4. Discard the empty JELMYTO vial.
    5. 5. Remove the remaining JELMYTO vial from the Chilling Block.
    6. 6. Inject the contents of the 20 mL syringe into that vial. Now all the admixture is contained in one vial.
    7. 7. Recap the vial adaptor.
    8. 8.

      Vigorously swirl the vial upright at least 15 times.

      Note: Do not invert or shake the vial.

    9. 9. Your JELMYTO admixture vial is now complete, with a resultant concentration of 4 mg of mitomycin per mL following reconstitution.
  6. F.

    Dispense Admixture Vial

    1. 1.

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

      Note: The "Discard after" date and time is 96 hours (4 days) from the completion of the preparation at room temperature.

    2. 2. Place the JELMYTO admixture vial in a light-protective bag.
    3. 3. Transport to the treatment facility along with the JELMYTO Instructions for Administration.

Important to Remember

  • All components must be kept cold during the preparation process by placing them in the Chilling Block when they are not in use.
  • If you have difficulty pushing the solution or withdrawing the solution at any time, put the components back in the Chilling Block until the product liquifies.

Frequently Asked Questions:

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 need to put the caps on the syringes and vials before placing them back into the chilling block?

YES, the chilling block inserts are not sterile. It is important to maintain aseptic technique.

Do I have to keep the vials upright when mixing?

If so, why?

YES, the vials should be upright during all 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 the solution or withdrawing the solution, place the components back into the Chilling Block until the product liquifies.

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

Distributed by:

UroGen Pharma, Inc.

Princeton, NJ 08540

www.JELMYTO.com

JELMYTO® and UroGen® are registered trademarks of UroGen Pharma, Ltd.

TEVADAPTOR® is a registered trademark of Simplivia Healthcare Ltd.

OnGuard® is a registered trademark of B. Braun Medical Inc.

Copyright© 2022 UroGen Pharma, Inc.

All rights reserved.

JEL-IFP-003

IFP-0002025/Ver. 4

INSTRUCTIONS FOR ADMINISTRATION (IFA)

JELMYTO® (jel-MYE-toe)

(mitomycin) for pyelocalyceal solution

For Pyelocalyceal Instillation Only

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

Purpose of this Instructions for Administration

This Instructions for Administration contains information on how to instill JELMYTO using the reconstituted JELMYTO vial which you received from the pharmacy and the devices listed under Supplies Needed, obtained by your facility.

Intended Use of JELMYTO

JELMYTO (mitomycin) for pyelocalyceal solution is indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC).

Important Information You Need to Know Before Instilling JELMYTO

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

Once instilled into the patient's pyelocalyceal system, JELMYTO will fill and conform to the cavity and become a gel, thereby exposing the tissue to mitomycin over a prolonged period of time.

JELMYTO is viscous, even when it is a liquid in a chilled state. Therefore, you will need a Uroject12 Syringe Lever to instill JELMYTO into the patient. You cannot instill JELMYTO without the Uroject12 device.

Reconstituted JELMYTO should be instilled as soon as possible after reconstitution. Store reconstituted JELMYTO at 20°C to 25°C (68°F to 77°F) for up to 96 hours (4 days). Protect from light.

When ready to instill, chill JELMYTO to 27°F to 41°F (-3°C to 5°C) for at least 10 minutes, but no longer than one hour, to revert it to a liquid form. See the Steps A through E for complete administration instructions.

JELMYTO is a cytotoxic anti-cancer drug. Procedures for Proper Handling and Disposal of anti-cancer drugs should be followed.

Supplies Needed:

One vial of reconstituted JELMYTO, with a resultant concentration of 4 mg of mitomycin per mL following reconstitution.

(prepared and provided by the pharmacy)

JELMYTO vial

Ancillary Supplies:

(to be provided by your facility)

Do not substitute any of these components.
  • TEVADAPTOR® Syringe Adaptor or OnGuard®2 CSTD Syringe Adaptor
  • MEDALLION® COP or MEDALLION® Luer Lock syringe, 20 mL
  • Ureteral Catheter with molded Luer lock port (5 Fr or 7 Fr)

  • Uroject12 Syringe Lever

    Note: The Uroject12 Syringe Lever is a multi-use device and must be sterilized or disinfected before use. Please follow the sterilization or disinfection instructions detailed in the Uroject12 Syringe Lever Instructions for Use.

  • An ice bath to chill the vial of JELMYTO prior to instillation.
TEVADAPTOR® or OnGuard®2 CSTD Syringe AdaptorMEDALLION® COP or MEDALLION® Luer Lock syringe, 20 mLUreteral Catheter with molded Luer lock port
Uroject12 Syringe LeverIce Bath

Instillation Instructions

  1. A.

    Measure the Kidney Volume

    The Instillation Volume will be equal to the patient's kidney volume. If the kidney volume is already known, proceed to Section B.

    If the kidney volume is NOT known, or needs to be reassessed, use the following steps:

    1. 1. Perform a retrograde pyelogram using diluted contrast (50%) so that the entire renal pelvis and calyces are observed and contrast starts to flow below the ureteropelvic junction (UPJ).
    2. 2. Record the volume of contrast injected at this point.
    3. 3.

      Allow the contrast to drain from the kidney. This may take about five minutes.

      Note: Do not withdraw contrast back into the syringe.

    4. 4. Repeat Steps 1 through 3 two more times, for a total of three measurements to improve accuracy.
    5. 5. Average the three volume measurements and round to the nearest whole number. This is the patient's kidney volume.
  2. B.

    Select the Instillation Volume

    Select the kidney volume OR 15 mL, whichever is lower, as the Instillation Volume.

    Note: Maximum Instillation Volume is 15 mL. Record this volume for future instillations.

  3. C.

    Chill the JELMYTO

    1. 1. Place the JELMYTO vial in the ice bath for at least 10 minutes, but no longer than one hour.
    2. 2. After at least 10 minutes, advance the ureteral catheter over the guidewire towards the target anatomy in the pyelocalyceal system.

  • Prepare the Administration Syringe

    Once the vial is removed from the ice bath, you have 4 minutes to draw JELMYTO into the administration syringe before it solidifies.

    After 4 minutes, recap and place the components back in the ice bath for no more than 15 minutes to liquify the JELMYTO.

    1. 1. Remove the JELMYTO vial from the ice bath and dry it off.
    2. 2. Swirl the vial upright to ensure that JELMYTO is uniformly mixed.
    3. 3. Connect the syringe adaptor to the 20 mL Luer Lock syringe. This will be the administration syringe.
    4. 4. Slowly withdraw the calculated Instillation Volume of JELMYTO into the administration syringe.
    5. 5.

      Press the "Clutch" button on the Uroject12 and pull the knob out.

    6. 6.

      Insert the administration syringe into the Uroject12 Syringe Lever and rotate it clockwise until it locks in place.

    7. 7.

      While pressing the "Clutch" button, advance the lever to just above the administration syringe's plunger.

      Immediately proceed with the instillation steps in Section E to avoid JELMYTO solidification.

  • Instill JELMYTO

    1. 1.

      Remove the syringe adaptor from the administration syringe.

      Note: If JELMYTO gets on to the syringe tip or the catheter's Luer Lock port, wipe it off immediately with sterile gauze so it does not solidify and prevent a secure connection. (Refer to Frequently Asked Questions for further details.)

    2. 2. Connect the administration syringe to the ureteral catheter's Luer Lock port, by rotating the syringe only.
    3. 3. Using fluoroscopy, ensure the ureteral catheter is in the desired anatomical position.
    4. 4.

      Gradually instill the JELMYTO into the patient by turning the knob at a rate of 1-2 seconds per stroke. The entire syringe must be emptied within one minute.

    5. 5. Remove the ureteral catheter from the urinary tract.
    6. 6. Remove the administration syringe from the Uroject12 by rotating the syringe barrel counter-clockwise.
    7. 7. Discard the administration ancillaries according to your facility's disposal procedures.
    8. 8. Send the Uroject12 to be reprocessed according to your facility's procedures and the Uroject12 Syringe Lever Instructions for Use.

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 reconstituted JELMYTO. It seems to be solidifying.

If you are having difficulty pushing or withdrawing JELMYTO, recap and place the components back into the ice bath until JELMYTO liquifies.

What should I do if there is JELMYTO spillage from the syringe tip?

You will need to clean JELMYTO off the syringe tip and the Luer Lock port of the catheter to ensure the two components can connect securely.

  • To clean the syringe tip, fold a sterile gauze pad in half twice, and push it into the inside of the Luer Lock port to wipe any JELMYTO off the threads.
  • To clean the Luer Lock port on the catheter, use a sterile gauze pad to wipe off any JELMYTO.

Verify that the connectors are clean to ensure a secure connection between the syringe and the catheter.

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

Distributed by:

UroGen Pharma, Inc.

Princeton, NJ 08540

www.JELMYTO.com

JELMYTO® and UroGen® are registered trademarks of UroGen Pharma, Ltd.

TEVADAPTOR® is a registered trademark of Simplivia Healthcare Ltd.

OnGuard® is a registered trademark of B. Braun Medical Inc.

MEDALLION® is a registered trademark of Merit Medical Systems, Inc.

Copyright© 2022 UroGen Pharma, Inc.

All rights reserved.

JEL-IFU-003

IFU-Phy-0006722/Ver. 5

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 211728 · View the label on DailyMed

Revision date stated in the text: September 2022

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 Jelmyto

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 211728New Drug Application (NDA) Approved April 15, 2020
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 72493-103-03

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.