Most frequent adverse events were renal and urinary
Adverse Reactions Reported In ≥ 10% (Any Grade; N=71)1*
| All Grades (%) | Grades ≥ 3 (%) | |
|---|---|---|
| Ureteric obstruction | 58 | 17 |
| Ureteric stenosis | 44 | 9 |
| Hydronephrosis | 18 | 6 |
| Urinary tract obstruction | 7 | 1.4 |
| Pelvi-ureteric obstruction | 6 | 1.4 |
| Ureteric obstruction | 2.8 | 1.4 |
| Obstructive uropathy | 1.4 | 0 |
| Flank pain† | 41 | 2.8 |
| Hematuria‡ | 34 | 2.8 |
| Urinary tract infection§ | 34 | 4.2 |
| Renal dysfunction‖ | 25 | 2.8 |
| Dysuria | 23 | 0 |
| Pollakiuria | 14 | 0 |
| Nausea | 25 | 1.4 |
| Abdominal pain¶ | 28 | 1.4 |
| Vomiting | 20 | 4.2 |
| Fatigue# | 27 | 1.4 |
| Pyrexia | 13 | 1.4 |
| Chills | 11 | 0 |
| Anemia | 14 | 1.4 |
| Pruritus | 13 | 0 |
| Decreased appetite | 10 | 0 |
| Hypertension | 10 | 4.2 |
- 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.
†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**
- 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.
