Is it a case for chemoablation?

These potential Jelmyto candidates present with a range of characteristics and histories.

Ted, 55

Newly diagnosed, primary disease

Sidney, 71

Recurrent, endoscopically managed

Mia, 76

Recurrent, comorbidities

Jonathan, 67

Bilateral disease
Profile photo of fictional patient named Ted

Does RNU have to be the next step for Ted’s unresectable primary disease?

Not an actual patient.

Ted, 55 years old, reported hematuria and flank pain. Urinalysis ruled out urinary tract infection. Cystoscopy ruled out bladder cancer.

Retrograde urography showed a large filling defect, and CT scan showed 2 endoscopically unresectable papillary tumors in the lower pole of the left renal pelvis. Ureteropyeloscopy and biopsy confirmed low-grade UTUC.

Father of 2 school-aged children, Ted is scared to lose a kidney. He prefers a noninvasive procedure that will not require extensive recovery.

    Key treatment considerations:
  • 2 kidneys
  • 2 unresectable papillary tumors
  • Diameter of largest tumor: 15 mm
  • Comorbidities: Hypertension
  • Treatment site: ASC
Jelmyto stays in the hard-to-reach areas of the renal pelvis for 4 to 6 hours, long enough to chemoablate Ted’s unresectable tumors.1See how Jelmyto rises to the challenge of the renal anatomy
Explore more of Ted’s case study and what Jelmyto can do for patients like him.Download PDF
ASC=ambulatory surgery center; CT=computerized tomography; RNU=radical nephroureterectomy.
Full Prescribing InformationArrow (right) icon

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

Contraindications

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
Lactation

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.

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.

References: 1. JELMYTO [package insert]. Princeton, NJ: UroGen Pharma, Inc.; 2022. 2. Lane BR, Smith AK, Larson BT, et al. Chronic kidney disease after nephroureterectomy for upper tract urothelial carcinoma and implications of the administration of chemotherapy. Cancer. 2010;116(12):2967-2973.