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(mysterious music)

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<v Announcer>Jelmyto: Rising to the challenge</v>

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of the renal anatomy.

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Introducing Jelmyto, the first and only

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FDA-approved treatment indicated for the treatment

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of low-grade upper tract urothelial cancer

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in adult patients.

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Jelmyto combines the anti-tumor activity of mitomycin

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with the innovative delivery mechanism of RTGel,

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reverse-thermal hydrogel, to make chemoablation

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a possibility in the upper tract.

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Jelmyto possesses unique, dynamic reverse-thermal properties

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that cause it to exist as a liquid at lower temperatures

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and convert to gel form at body temperature,

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providing a first-of-its-kind treatment

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for sustained exposure of a chemoablative drug

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in the renal pelvis.

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Jelmyto is chilled and administered via a ureteral catheter

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into the pyelocalyceal system.

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While in liquid form, Jelmyto fills and conforms

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to the hard-to-reach areas of the renal pelvis.

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As Jelmyto reaches body temperature,

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it forms a semisolid gel, coating both resectable

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and unresectable tumors.

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Jelmyto stays in the collecting system long enough

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to chemoablate tumors without being washed away,

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providing up to four to six hours

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of sustained exposure to mitomycin.

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Over the course of a few hours, Jelmyto gradually dissolves

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and is excreted via normal urine flow.

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(gentle upbeat music)

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Jelmyto offers the convenience

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of same-day outpatient administration.

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Jelmyto: Every patient deserves a chance

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to spare their kidney for tomorrow.

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Indications and Usage

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Jelmyto (mitomycin) for pyelocalyceal solution is indicated

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for the treatment of adult patients

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with low-grade upper tract urothelial cancer, LG-UTUC.

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Important Safety Information

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Contraindications

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Jelmyto is contraindicated in patients with perforation

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of the bladder or upper urinary tract.

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Ureteric Obstruction

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Ureteric obstruction, including ureteral stenosis

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and hydronephrosis, occurred in patients receiving Jelmyto.

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Monitor patients for signs and symptoms

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of ureteric obstruction, including flank pain, and fever,

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and for changes in renal function.

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Patients who experience obstruction may require transient

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or long-term ureteral stents or alternative procedures.

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Withhold or permanently discontinue Jelmyto based

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on the severity of ureteric obstruction.

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Bone Marrow Suppression

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The use of Jelmyto can result in bone marrow suppression,

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particularly thrombocytopenia and neutropenia.

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The following tests should be obtained prior

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to each treatment: Platelet count,

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white blood cell count differential and hemoglobin.

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Withhold Jelmyto for Grade 2 thrombocytopenia

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or neutropenia.

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Permanently discontinue for Grade 3

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or greater thrombocytopenia or neutropenia.

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Embryo-Fetal Toxicity

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Based on findings in animals and mechanism of action,

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Jelmyto can cause fetal harm when administered

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to a pregnant woman.

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In animal reproduction studies, administration of mitomycin

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resulted in teratogenicity.

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Advise females of reproductive potential

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to use effective contraception

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during treatment with Jelmyto and for 6 months

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following the last dose.

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Advise male patients with female partners

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of reproductive potential to use effective contraception

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during treatment with Jelmyto

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and for 3 months following the last dose.

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Common Adverse Reactions

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The most common adverse reactions in greater than

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or equal to 20% of patients treated with Jelmyto

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were ureteric obstruction, flank pain,

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urinary tract infection, hematuria, abdominal pain, fatigue,

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renal dysfunction, nausea, dysuria, and vomiting.

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Additional Adverse Reactions Information

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Selected clinically relevant adverse reactions

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in less than 10% and greater than or equal to 2% of patients

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who received Jelmyto include urinary tract inflammation,

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bladder spasm, urosepsis, hypersensitivity,

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and instillation site pain.

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Use in Specific Populations

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Lactation

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Because of the potential for serious adverse reactions

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in a breastfed child, advise women not to breastfeed

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during treatment with Jelmyto

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and for one week following the last dose.

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Preparation and Administration Information

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Jelmyto is for pyelocalyceal use only

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and not for intravenous use, topical use,

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or oral administration.

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Jelmyto must be prepared and administered

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by a healthcare provider.

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To ensure proper dosing,

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it is important to follow the preparation instructions found

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in the Jelmyto Instructions

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for Pharmacy and administration instructions found

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in the Jelmyto Instructions for Administration.

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Jelmyto may discolor urine to a violet to blue color

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following the instillation procedure.

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Advise patients to avoid contact with urine

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for at least six hours post-instillation,

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to void urine sitting on a toilet,

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and to flush the toilet several times after use.

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Jelmyto is a hazardous drug.

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Follow applicable special handling and disposal procedures.

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Please see accompanying Full Prescribing Information,

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Instructions for Pharmacy,

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and Instructions for Administration.

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(gentle upbeat music continues)

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Please visit Jelmyto.com/hcp for more information.