Safety

The versatility to give patients with low-grade UTUC the chance to spare their kidney1*

  • Jelmyto can be used alone or following endoscopic management to treat low-grade UTUC across diverse presentations
Low-Volume/
Unifocal Disease
Higher-Volume/
Multifocal Disease
Unreachable
Tumor(s)
Mitomycin for pyelocalyceal solution (Jelmyto) should not be instilled immediately following resection or ablation. Please refer to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and AUA/SUO Guideline for principles of instillation therapy.*Jelmyto is instilled via the pyelocalyceal system in a procedure that spares the kidney.
Kidney illustration with circled tumor

Multimodal Treatment Option:

  • Resection or ablation of visible disease2
    and/or
  • Chemoablation with Jelmyto once weekly for 6 weeks for sustained exposure to mitomycin1
Kidney illustration with circled tumors
Kidney illustration with circled tumor

By delivering chemoablative therapy to the upper tract, Jelmyto completes the primary treatment regimen for patients with low-grade UTUC, even those with endoscopically unreachable tumors

Featured resources

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Jelmyto Clinical Story

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Multimodal Treatment Algorithm

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Scheduling and Ordering Resource

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Jelmyto Patient Enrollment Form

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Rising to the challenge of the renal anatomy

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Multimodal treatment algorithm

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

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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.

References: 1. JELMYTO [package insert]. Princeton, NJ: UroGen Pharma, Inc.; 2022. 2. Rouprêt M, Gontero P, Birtle A, et al. EAU Guidelines on Upper Urinary Tract Urothelial Carcinoma. European Association of Urology; 2023.