Safety

Resources for you and your practice

The following downloads, links, and forms can help you and your practice navigate the treatment course with Jelmyto.

Support and Affordability

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Program Overview

A brochure dedicated to services provided by UroGen SupportTM.

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Scheduling and Ordering Resource

A brochure outlining the 4 simple steps to getting started with Jelmyto.

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Return Goods Overview

A visual summary of the return goods process for JELMYTO.

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How to Bill Jelmyto Guide

See preparation and instillation quantities for Jelmyto and learn what is required for accurate billing and sufficient reimbursement.

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Jelmyto Product Fact Sheet

Information about Jelmyto including NDC, WAC, support, and distributor information.

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Price Increase Announcement

Information about the Jelmyto WAC increase.

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UroGen® Return Goods Policy

A comprehensive resource on returned goods including eligible returns, credit and reimbursement, and return procedure.

Practice Forms and Documents

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Jelmyto Patient Enrollment Form

Enroll patients in the UroGen SupportTM program.

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Credit Request Form

Initiate a credit request to your account.

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Account Setup Form

Affirm your account or set up a new account with Cardinal Health SPD.

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Account Setup Checklist

Key information to help navigate the account setup process.

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Prior Authorization Checklist

Provides information that is generally used to determine medical necessity by payer.

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Claims Submission Checklist

Key information to help navigate the claims submission process.

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Letter of Medical Necessity

Customizable letter supporting Jelmyto use in appropriate patients.

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Appeals Letter

Customizable letter of appeal for denial of coverage.

Jelmyto Resources and Downloads

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AUA/SUO and NCCN Guidelines for Jelmyto

An overview of each organization's recommendation of kidney-sparing treatment for low-grade UTUC and how Jelmyto fits in.

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Jelmyto Enhanced Media Kit

Communication starter kit to help educate staff and surrounding practices on Jelmyto.

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Jelmyto Clinical Story

Key information about the clinical trial, administration, and additional resources.

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Multimodal Treatment Algorithm

Access which treatment option is right for your patient with low-grade UTUC.

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Patient Profile:
Ted

Profile of a patient with unresectable, primary disease.

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Patient Profile:
Mia

Profile of a patient with advanced age and comorbidities.

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Patient Profile:
Sidney

Profile of a patient with recurrence after endoscopic management.

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Patient Profile:
Jonathan

Profile of a patient with bilateral disease.

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Instructions for Administration

Step-by-step guide for administering Jelmyto via ureteral catheter.

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Instructions for Pharmacy

Step-by-step guide for preparing Jelmyto.

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Antegrade Instillation Overview

Clinical considerations and real-world study experience from multiple practice sites.

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Nephrostomy Instructions

Step-by-step guide for administering Jelmyto via nephrostomy tube.

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Nephrostomy Order Form

Request for nephrostomy tube placement with kidney volume measurement.

Full Prescribing InformationArrow (right) icon

Indications and Usage

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

Important Safety Information

Contraindications

Jelmyto is contraindicated in patients with perforation of the bladder or upper urinary tract.

Ureteric Obstruction

Ureteric obstruction, including ureteral stenosis and hydronephrosis, occurred in patients receiving Jelmyto. Monitor patients for signs and symptoms of ureteric obstruction, including flank pain, and fever, and for changes in renal function. Patients who experience obstruction may require transient or long-term ureteral stents or alternative procedures. Withhold or permanently discontinue JELMYTO based on the severity of ureteric obstruction.

Bone Marrow Suppression

The use of Jelmyto can result in bone marrow suppression, particularly thrombocytopenia and neutropenia. The following tests should be obtained prior to each treatment: Platelet count, white blood cell count differential and hemoglobin. Withhold JELMYTO for Grade 2 thrombocytopenia or neutropenia. Permanently discontinue for Grade 3 or greater thrombocytopenia or neutropenia.

Embryo-Fetal Toxicity

Based on findings in animals and mechanism of action, Jelmyto can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of mitomycin resulted in teratogenicity. Advise females of reproductive potential to use effective contraception during treatment with JELMYTO and for 6 months following the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with JELMYTO and for 3 months following the last dose.

Common Adverse Reactions

The most common adverse reactions in ≥ 20% of patients treated with Jelmyto were ureteric obstruction, flank pain, urinary tract infection, hematuria, abdominal pain, fatigue, renal dysfunction, nausea, dysuria, and vomiting.

Additional Adverse Reactions Information

Selected clinically relevant adverse reactions in < 10% and ≥ 2% of patients who received Jelmyto include urinary tract inflammation, bladder spasm, urosepsis, hypersensitivity, and instillation site pain.

Use in Specific Populations
Lactation

Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with Jelmyto and for 1 week following the last dose.

Preparation and Administration Information

Jelmyto is for pyelocalyceal use only and not for intravenous use, topical use, or oral administration. Jelmyto must be prepared and administered by a healthcare provider. To ensure proper dosing, it is important to follow the preparation instructions found in the JELMYTO Instructions for Pharmacy and administration instructions found in the JELMYTO Instructions for Administration.

Jelmyto may discolor urine to a violet to blue color following the instillation procedure. Advise patients to avoid contact with urine for at least six hours post-instillation, to void urine sitting on a toilet, and to flush the toilet several times after use.

Jelmyto is a hazardous drug. Follow applicable special handling and disposal procedures.

Please click here for Full Prescribing Information, Instructions for Pharmacy, and Instructions for Administration.