Safety

Get resources, benefits investigation support, affordability options, and customized online support

The UroGen SupportTM Online Portal makes getting access to Jelmyto as seamless as possible. By enrolling in this customized support platform, you can

Order Jelmyto for
your patients
Initiate
benefits
investigations
Determine affordability
and financial
assistance
Access important
forms and resources

Are you a new Jelmyto customer? Set up an account and enroll in the portal in 2 easy steps.

If you have any questions, please contact UroGen® Pharma at 1-855-JELMYTO

With a dedicated team and end-to-end support, UroGen SupportTM is here to make the access, reimbursement, and coordination process as simple as possible for you and your patients. Our support team can help with the following:

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Copay Program

Eligible, commercially insured patients may qualify for the UroGen SupportTM Copay Program, which allows them to pay as little as $50 for a dose of Jelmyto.

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Patient Assistance Program

Patients without insurance may benefit from the UroGen SupportTM Patient Assistance Program if they qualify.

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Assistance for Patients with Medicare and Medicaid

Charitable organizations may help cover the costs of treatment for eligible patients with Medicare or Medicaid. These programs are not affiliated with UroGen Pharma.

If you have any questions, please contact UroGen Pharma at 1-855-JELMYTO

  • Communications regarding prior authorization and coverage appeal
  • Pharmacy and site coordination for product acquisition, preparation, and delivery

Featured resources

Download these resources to learn more and to get your appropriate patients started on Jelmyto treatment.

Prior Authorization Checklist

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Claims Submission Checklist

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Appeals Letter

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Additional Resources

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From patient enrollment to instillation tracking, our online support portal offers a comprehensive and customized support platform.

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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.