Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 12/6/2022

Drug Summary

What Is Jelmyto?

Jelmyto (mitomycin) is an alkylating drug used to treat adult patients with low-grade upper tract urothelial cancer (LG-UTUC).

What Are Side Effects of Jelmyto?

Jelmyto may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • pain or difficult urination,
  • blood in your urine,
  • fever,
  • chills,
  • tiredness,
  • mouth sores,
  • skin sores,
  • easy bruising,
  • unusual bleeding,
  • pale skin,
  • cold hands and feet,
  • lightheadedness, and
  • shortness of breath

Get medical help right away, if you have any of the symptoms listed above.

Side effects of Jelmyto include:

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Jelmyto

The dose of Jelmyto to be instilled is 4 mg per mL via ureteral catheter or nephrostomy tube, with total instillation volume based on volumetric measurements using pyelography, not to exceed 15 mL (60 mg of mitomycin). Jelmyto is instilled once weekly for six weeks.

Jelmyto In Children

Safety and efficacy of Jelmyto in pediatric patients have not been established.

What Drugs, Substances, or Supplements Interact with Jelmyto?

Jelmyto may interact with other medicines.

Tell your doctor all medications and supplements you use.

Jelmyto During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Jelmyto; it can harm a fetus. Females and males with female partners of reproductive potential are advised to use effective contraception during treatment with Jelmyto and for 3 months following the last dose. Because of the potential for serious adverse reactions in a breastfed child, breastfeeding is not recommended while using Jelmyto and for 1 week following the last dose.

Additional Information

Our Jelmyto (mitomycin) for Pyelocalyceal Solution Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Drug Description


Mitomycin (also known as mitomycin-C) is an alkylating drug isolated from the broth of Streptomyces caespitosus. Mitomycin is a blue-violet crystalline powder with a molecular formula of C15H18N4O5, and a molecular weight of 334.33. Its chemical name is 7-amino-9α-methoxymitosane and it has the following structural formula:

Jelmyto™ (mitomycin) Structural Formula - Illustration

Mitomycin is heat stable, has a high melting point, and is freely soluble in organic solvents.

Jelmyto is supplied in a single-dose carton containing two vials of sterile lyophilized mitomycin for pyelocalyceal solution, 40 mg each, and one vial of 20 mL of sterile hydrogel, to be used as a vehicle for reconstitution.

Mitomycin for pyelocalyceal solution is a sterile, lyophilized, grey to greyish-purple, cake or powder that contains mitomycin 40 mg and mannitol 80 mg in each vial.

Sterile hydrogel is a sterile, clear, colorless, gel with or without bubbles at room temperature or clear, colorless liquid at 2°C to 8°C (36°F to 46°F), which contains 0.04 g hydroxypropyl methylcellulose, 5.67 g poloxamer, 0.21 g polyethylene glycol, and water for injection in each vial.

Once reconstituted, Jelmyto is a clear, purple, viscous liquid at 2°C to 8°C (36°F to 46°F) or semisolid gel at room temperature with a concentration of 4 mg per mL of mitomycin, which may contain a few visible particles and have a pH between 6.0 and 8.0.

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Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.