Most frequent adverse events were renal and urinary

Adverse Reactions Reported In ≥ 10% (Any Grade; N=71)1*

All Grades (%)Grades ≥ 3 (%)
Ureteric obstruction5817
     Ureteric stenosis449
     Urinary tract obstruction71.4
     Pelvi-ureteric obstruction61.4
     Ureteric obstruction2.81.4
     Obstructive uropathy1.40
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 reaction1
*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**

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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.

Please click here for JELMYTO Full Prescribing Information, including the Patient Information, for additional information.

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