Instillation: Ureteral Catheter

Watch the video below for the full instructions on how to administer Jelmyto with a ureteral catheter.

Instructions for Administration

Download the Jelmyto Instructions for Administration (IFA) for a step-by-step guide for administering Jelmyto with a ureteral catheter.

Download (PDF) Jelmyto Instructions for Administration



Instillation: Nephrostomy Tube

Watch the video below for the full instructions on how to administer Jelmyto with a nephrostomy tube.

Nephrostomy Instructions Download the Instruction Guide for Instillation of Jelmyto with a Nephrostomy Tube for step-by-step administration instructions.

Download (PDF) Instruction Guide for Instillation of Jelmyto with a Nephrostomy Tube



Jelmyto is a primary treatment instilled via catheter once weekly for 6 weeks for the possibility of complete response1*

Preparation Icon

PREPARATION1,2
  • Reconstituted Jelmyto can be stored for up to 96 hours (4 days) at room temperature
  • Can be done in an outpatient setting (fluoroscopy required)
  • General anesthesia is not required
    • Used in 37% of patients for at least one instillation during the treatment period. Local anesthesia or sedation was used at the discretion of the physician

Instillation Icon

INSTILLATION1,3
  • Jelmyto is instilled once weekly for 6 weeks
  • 86% of patients treated with Jelmyto received the full recommended 6 doses
  • Jelmyto is instilled as a chilled liquid with a Uroject12 Syringe Lever and a 5 or 7 French ureteral catheter or via nephrostomy tube
  • Jelmyto should NOT be instilled immediately following resection or ablation

Post-Procedure Icon

POST-PROCEDURE1
  • Once it fills the renal pelvis, Jelmyto forms a gel that provides sustained exposure for up to 4 to 6 hours
  • Excreted via normal urine flow
  • Since it's an outpatient procedure, patients can typically go home the same day

*In the Olympus Study, 58% of patients receiving Jelmyto achieved complete response.1
Prior to administration, Jelmyto must be reconstituted by the pharmacy. On average, pharmacy partners report 45-60 minutes for the reconstitution of Jelmyto. (Individual times may vary.)

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. Kleinmann N, Matin SF, Pierorazio PM, et al. Primary chemoablation of low-grade upper tract urothelial carcinoma using UGN-101, a mitomycin-containing reverse thermal gel (OLYMPUS): an open-label, single-arm, phase 3 trial. Lancet Oncol. 2020;21(6):776-785. 3. JELMYTO Instructions for Administration. Princeton, NJ: UroGen Pharma, Inc.; 2022.