Most frequent adverse events were renal and urinary1

Adverse Reactions Reported In ≥ 10% (Any Grade; N=71)*

All Grades (%)Grades ≥ 3 (%)
Ureteric obstruction5817

Ureteric stenosis




Urinary tract obstruction


Pelvi-ureteric obstruction


Ureteric obstruction


Obstructive uropathy

Flank pain412.8
Urinary tract infection§344.2
Renal dysfunction252.8
Abdominal pain281.4
Decreased appetite100
  • 24% of the overall population discontinued treatment due to an adverse reaction
Graded per National Cancer Institute Common Terminology Criteria for Adverse Events. Version 5.0 (NCI CTCAE v5).
Includes flank pain and back pain.
Includes hematuria and hemorrhage urinary tract.
Includes urinary tract infection, pyelonephritis, and urinary tract infection fungal.
Includes renal impairment, acute kidney injury, and renal failure.
Includes abdominal pain and abdominal pain lower.
Includes asthenia and fatigue.

Ureteric obstruction: What you need to know

In the Olympus Study, ureteric obstruction was reported in 58% of patients (n=41)1**

Chart showing that most ureteric obstruction events were mild to moderate

  • In patients receiving Jelmyto, median time to onset was 2.4 months (range 0.5-15.4 months). This was after the period of the primary 6 instillations
    • Ureteric obstruction was reported in 17 of the 42 patients who only received Jelmyto during the treatment (no maintenance therapy)
  • Monitor patients for signs and symptoms of ureteric obstruction
  • Jelmyto is approved for instillation via nephrostomy tube; this may be considered as an alternative administration option
Includes hydronephrosis, obstructive uropathy, pelvi-ureteric obstruction, ureteric obstruction, ureteric stenosis, and urinary tract obstruction.

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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


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

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. Data on file. UroGen Pharma, Inc., Princeton, NJ.