Most frequent adverse events were renal and urinary
ADVERSE REACTIONS REPORTED IN ≥10% (ANY GRADE; N=71)1*
| ALL GRADES (%) | GRADE ≥3 (%) | |
|---|---|---|
| Ureteric obstruction | 58 | 17 |
| Ureteric stenosis | 44 | 8 |
| Hydronephrosis | 18 | 6 |
| Pelvi-ureteric obstruction | 6 | 1.4 |
| Urinary tract obstruction | 6 | 1.4 |
| Ureteric obstruction | 2.8 | 1.4 |
| Obstructive uropathy | 1.4 | 0 |
| Flank pain† | 39 | 2.8 |
| Urinary tract infection‡ | 34 | 4.2 |
| Hermaturia§ | 32 | 2.8 |
| Renal dysfunction‖ | 25 | 2.8 |
| Dysuria | 21 | 0 |
| Pollakiuria | 13 | 0 |
| Nausea | 24 | 1.4 |
| Abdominal pain¶ | 23 | 1.4 |
| Vomiting | 20 | 4.2 |
| Fatigue# | 24 | 1.4 |
| Chills | 11 | 0 |
| Pyrexia | 11 | 0 |
| Anemia | 13 | 0 |
| Pruritus | 13 | 0 |
- 23% of the overall population discontinued treatment due to an adverse reaction1
†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**
- 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
Approved Use for JELMYTO
JELMYTO™ is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).
Important Safety Information
You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.
Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you
- are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby. You should not become pregnant during treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO.
Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose.
Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose. - are breastfeeding or plan to breastfeed. It is not known if JELMYTO passes into your breast milk. Do not breastfeed during treatment with JELMYTO and for 1 week after the last dose.
- Tell your healthcare provider if you take water pills (diuretic).
How will I receive JELMYTO?
- Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO treatment.
- You will receive your JELMYTO dose from your healthcare provider 1 time a week for 6 weeks. It is important that you receive all 6 doses of JELMYTO according to your healthcare provider’s instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. Your healthcare provider may recommend up to an additional 11 monthly doses.
- JELMYTO is given to your kidney through a tube called a catheter.
- During treatment with JELMYTO, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.
After receiving JELMYTO:
- JELMYTO may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 6 hours.
- To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.
- Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.
JELMYTO may cause serious side effects, including:
- Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction). If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain. Tell your healthcare provider right away if you develop side pain or fever during treatment with JELMYTO.
- Bone marrow problems. JELMYTO can affect your bone marrow and can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with JELMYTO. Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO.
The most common side effects of JELMYTO include: side pain, urinary tract infection, blood in your urine, kidney problems, tiredness, nausea, stomach pain, trouble with urination, vomiting, low red blood cell count, frequent urination, itching, chills, and fever.
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.