WEBVTT
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My name is Marc Bjurlin.
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I'm a urologic oncologist here
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at the University of North Carolina at Chapel Hill.
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In my practice, I've used JELMYTO
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in a number of presentations
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for low-grade urothelial carcinoma.
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Our approach to administering JELMYTO has
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really evolved over time.
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For the vast majority of patients,
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I use the antegrade approach.
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Our patients typically get their nephrostomy tube
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a couple weeks in advance, and then about a week or two
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after the nephrostomy tube is placed,
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the patients will then come to our clinic appointment
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and start their instillation.
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From the time the patient arrives to the clinic
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to the time the patient leaves is very quick,
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typically less than 15 minutes,
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and the instillation of the drug itself
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is only a couple minutes.
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We now have our patient in position.
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She's in the left lateral decubitus position
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with the right side up
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since this will be instillation into her right kidney.
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We've prepared the JELMYTO drug.
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It's been on the ice bath now for 10 minutes,
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and we're ready to draw it up into the Uroject syringes.
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For this patient, we'll be using 10 milliliters
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followed by a 2 milliliter cold saline flush.
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Next, we swirl the vial in an upright position
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to ensure that the JELMYTO is uniformly mixed.
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We can then connect the syringe adapter
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to the 20 milliliter Luer-lock syringe.
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After the syringe has been connected,
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we then invert the vial,
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and slowly withdraw the calculated instillation volume
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of the JELMYTO into the administration syringe.
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After the drug has been drawn up in the syringe,
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we'll now place it into the Uroject device.
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We do use the Uroject device
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because the drug is a little bit viscous
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and this allows us to easily instill the drug
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into the kidney in a smooth manner.
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The patient has a nephrostomy tube in place,
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and we've prior checked the placement with a urine drip.
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The Uroject syringe is then easily hooked up
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to the Luer-lock syringe of the nephrostomy tube,
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and then we gently instill the drug into her kidney.
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We instill it at a pace that is quick enough
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so the drug doesn't actually warm to room temperature
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while we're instilling it,
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but at the same time, not too fast,
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as that could possibly make her kidney
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a little bit hydronephrotic, resulting in flank pain.
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So we'll go ahead and twist the 10 milliliters of JELMYTO
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into the nephrostomy tube,
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and after that is complete, we'll then switch out
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to the 2 milliliters of cold saline flush.
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And we do use cold saline, again, just to make sure
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the JELMYTO stays cold in that liquid state,
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and does not warm up into a gel outside the body
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in that nephrostomy tube.
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So this instillation is now complete.
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The full 10 milliliters has gone in.
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We remove this Uroject
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and then simply bring in the 2 milliliters of cold saline.
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Same fashion.
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This is just gently instilled through the nephrostomy tube,
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again, to flush the line
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to make sure there's no residual drug
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in the nephrostomy tube line,
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and all the drug has been placed into her kidney.
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The Uroject device is then removed.
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And we simply put a new cap on the nephrostomy tube,
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and the instillation is then completed.
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(light music)
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In my practice, I've used JELMYTO
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in a number of presentations
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for low-grade urothelial carcinoma.
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I've treated small subpapillary tumors,
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I've treated large tumors,
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and I've treated multifocal tumors
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that have carpeted the whole entire kidney,
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and then ureteral tumors,
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which are often challenging to ablate,
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given how thin the ureter is.
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JELMYTO has an opportunity to increase
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the dwell time of the drug in that position.
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When treating with JELMYTO,
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we do know there are some potential adverse effects.
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Specifically, there's been reported
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potential ureteral obstruction,
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and there may be a need for either dilation
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or long-term stent placement.
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The systemic absorption of the drug is low,
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but there is potential for bone marrow suppression.
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As a result, typically, in my practice,
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these patients get weekly CBCs
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and BMPs to keep an eye on that.
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And if that ever was to occur, typically we stop the drug,
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repeat the laboratory results,
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and if they resolve, we continue the drug.
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The outcomes I've seen in my practice from using JELMYTO
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have been quite promising.
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It's been beneficial to patients
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in a number of different clinical scenarios,
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as I've had patients who would really benefit
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from avoiding a nephroureterectomy
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and have a kidney-sparing approach.
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(light music)
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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. Contraindications.
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JELMYTO (mitomycin) for pyelocalyceal solution
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is contraindicated in patients
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with perforation of the bladder or upper urinary tract.
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Warnings and Precautions.
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Ureteric Obstruction. Ureteric obstruction,
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including ureteral stenosis and hydronephrosis,
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occurred in patients receiving JELMYTO.
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Monitor patients for signs
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and symptoms of ureteric obstruction,
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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
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or alternative procedures.
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Withhold or permanently discontinue JELMYTO
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based 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
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prior to each treatment:
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Platelet count, white blood cell count differential
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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
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when administered to a pregnant woman.
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In animal reproduction studies,
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administration of mitomycin resulted in teratogenicity.
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Advise females of reproductive potential to use
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effective contraception during treatment with JELMYTO
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and for 6 months 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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Adverse Reactions. 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 were
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ureteric obstruction, flank pain,
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urinary tract infection, hematuria, renal dysfunction,
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nausea, abdominal pain, fatigue, 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
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or equal to 2% of patients who received JELMYTO include
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urinary tract inflammation, bladder spasm,
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urosepsis, hypersensitivity,
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and instillation site pain.
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Use in Specific Populations.
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Lactation. Because of the potential
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for serious adverse reactions in a breastfed child,
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advise women not to breastfeed during treatment with JELMYTO
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and for 1 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
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and administered 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 for Pharmacy
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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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Visit JELMYTO.com/hcp for Full Prescribing Information
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and Instruction Guide for instillation of JELMYTO
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(mitomycin) for pyelocalyceal solution
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with a nephrostomy tube.
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(light music)