Most frequent adverse events were renal and urinary

ADVERSE REACTIONS REPORTED IN ≥10% (ANY GRADE; N=71)1*

ALL GRADES (%)GRADE ≥3 (%)
Ureteric obstruction5817
     Ureteric stenosis448
     Hydronephrosis186
     Pelvi-ureteric obstruction61.4
     Urinary tract obstruction61.4
     Ureteric obstruction2.81.4
     Obstructive uropathy1.40
Flank pain392.8
Urinary tract infection344.2
Hermaturia§322.8
Renal dysfunction252.8
Dysuria210
Pollakiuria130
Nausea241.4
Abdominal pain231.4
Vomiting204.2
Fatigue#241.4
Chills110
Pyrexia110
Anemia130
Pruritus130
  • 23% 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 urinary tract infection, pyelonephritis, and urinary tract infection fungal.
§Includes hematuria and hemorrhage urinary tract.
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

  • The median time to first onset was 2.4 months (range 0.5-15.4 months). This was after the period of the primary 6 instillations1
    • In patients who only received JELMYTO during the treatment phase, ureteric obstruction was reported in 40% (n=17)
  • 36 patients required ureteral stent placement1
    • Clinical management was at the discretion of the physician2
    • The median duration of in-dwelling stents was 51 days (range 1-292 days)1
  • Monitor patients for signs and symptoms of ureteric obstruction
**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 http://www.fda.gov/medwatch 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.

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