WEBVTT

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<v Announcer>JELMYTO Administration Guide</v>

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for Pyelocalyceal Instillation

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With Nephrostomy Tube Only.

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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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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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Read and follow this administration guide

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prior to each JELMYTO instillation.

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This video contains information on how

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to instill JELMYTO using the reconstituted JELMYTO vial,

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which you received from the pharmacy,

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and the devices listed under Supplies Needed

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obtained by your facility.

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JELMYTO (mitomycin) for pyelocalyceal solution

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is indicated for the treatment of adult patients

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with low-grade upper tract urothelial cancer (LG-UTUC).

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The most common adverse reactions

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in greater than or equal to 20% of patients

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treated with JELMYTO 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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Important information you need to know

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before instilling JELMYTO.

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JELMYTO must be reconstituted

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by a healthcare professional prior to instillation.

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Reconstituted JELMYTO will appear as a semisolid gel.

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Once chilled, JELMYTO will convert

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to a viscous liquid for instillation.

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Once instilled into the patient's pyelocalyceal system,

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JELMYTO will fill and conform to the cavity

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and become a gel, thereby exposing the tissue

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to mitomycin over a prolonged period of time.

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JELMYTO is viscous even when it is a

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liquid in a chilled state.

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Therefore, you'll need a Uroject12 Syringe Lever

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to instill JELMYTO into the patient.

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You cannot instill JELMYTO without the Uroject12 device.

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Instill as soon as possible after reconstitution.

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Store reconstituted JELMYTO at 68 degrees Fahrenheit

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to 77 degrees Fahrenheit

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(20 degrees Celsius to 25 degrees Celsius)

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for up to 96 hours (4 days).

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Protect from light.

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When ready to instill,

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chill JELMYTO to 27 degrees Fahrenheit

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to 41 degrees Fahrenheit,

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(-3 degrees Celsius to 5 degrees Celsius)

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for at least 10 minutes,

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but no longer than one hour, to revert it to a liquid form.

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See the Steps A through E

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for complete administration instructions.

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JELMYTO is a cytotoxic anti-cancer drug.

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Procedures for proper handling

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and disposal of anti-cancer drugs should be followed.

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Supplies needed

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To instill JELMYTO,

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you will need one vial of reconstituted JELMYTO,

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with a resultant concentration

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of 4 milligrams of mitomycin per milliliter

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following reconstitution.

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This will be prepared and provided by the pharmacy.

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You will also need the following ancillary supplies,

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which will be provided by your facility.

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Do not substitute any of these components.

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TEVADAPTOR Syringe Adaptor

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or OnGuard2 CSTD Syringe Adaptor.

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MEDALLION COP or MEDALLION Luer Lock syringe, 20 milliliter.

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2.5 milliliter to 5 milliliter syringe.

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Needle for drawing up saline.

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Saline.

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Uroject12 Syringe Lever.

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Note:

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The Uroject12 Syringe Lever is a multi-use device

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and must be sterilized or disinfected before use.

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Please follow the sterilization or disinfection instructions

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detailed in the

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Uroject12 Syringe Lever Instructions for Use.

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An ice bath to chill the vial of JELMYTO

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prior to instillation.

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Section A: Measure the kidney volume.

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The instillation volume will be equal

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to the patient's kidney volume.

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Note:

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The kidney volume may be measured

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either retrograde or antegrade.

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If the volume was measured antegrade,

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then subtract 2 milliliters from each measurement

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prior to averaging to account for the internal dwell volume

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in the nephrostomy tube (dead space).

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There is no need to subtract 2 milliliters

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if measured retrograde.

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If the kidney volume is already known,

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proceed to Section B.

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If the kidney volume is not known,

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or needs to be reassessed, use the following steps.

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Perform volumetric measurements using pyelography

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with diluted contrast so that the entire renal pelvis

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and calyces are observed

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and contrast starts to flow

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below the ureteropelvic junction (UPJ).

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Note:

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Slow administration of the contrast may facilitate

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a more accurate measurement

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since contrast could be drained into the ureter.

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Record the volume of contrast injected at this point.

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Allow the contrast to drain from the kidney.

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This may take about 5 minutes.

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Note: Do not withdraw contrast back into the syringe.

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Repeat Steps 1 through 3 two more times

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for a total of three measurements to improve accuracy.

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Note:

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If the volume was measured antegrade,

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then subtract 2 milliliters from each measurement

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prior to averaging to account for the internal dwell volume

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in the nephrostomy tube (dead space).

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Section B: Select the Instillation Volume

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Select the kidney volume,

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or 15 milliliters, whichever is lower,

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as the Instillation Volume.

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Note: Maximum Instillation Volume is 15 milliliters.

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Record this volume for future instillations.

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Important Information Regarding Nephrostomy Instillation.

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Note: Follow practice

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or institutional protocols regarding placement

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for nephrostomy tube and time allowance for healing

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before proceeding with JELMYTO instillation.

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Also follow nephrostomy tube protocol

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following treatment course.

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A percutaneous nephrostomy tube, not nephroureteral stent,

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with molded Luer Lock connector and locking loop

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must be placed prior to instillation of JELMYTO.

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Latex catheters or nephrostomy tubes made of latex

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should not be used during JELMYTO administration

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due to the risk of deformation attributed

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with pressure changes,

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which can impede flow of the hydrogel admixture.

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Section C: Chill the JELMYTO.

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Place the JELMYTO vial in the ice bath

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for at least 10 minutes, but no longer than 1 hour.

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Section D: Prepare the administration syringe.

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Once the vial is removed from the ice bath,

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you have 4 minutes to draw JELMYTO

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into the administration syringe before it solidifies.

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After 4 minutes, recap and place the components

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back in the ice bath

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for no more than 15 minutes to liquify the JELMYTO.

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Remove the JELMYTO vial from the ice bath and dry it off.

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Swirl the vial upright

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to ensure the JELMYTO is uniformly mixed.

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Connect the syringe adaptor

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to the 20 milliliter Luer Lock syringe.

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This will be the administration syringe.

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Slowly withdraw the calculated Instillation Volume

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of JELMYTO into the administration syringe.

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Press the "Clutch" button on the Uroject12

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and pull the knob out.

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Insert the administration syringe

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into the Uroject12 Syringe Lever

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and rotate it clockwise until it locks in place.

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While pressing the "Clutch" button, advance the lever

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to just above the administration syringe's plunger.

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Immediately proceed with the instillation steps in Section E

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to avoid JELMYTO solidification.

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Section E: Instill JELMYTO.

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Prior to administration, implement your clinic's practice

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for reviewing patient's labs,

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inspecting the nephrostomy tube for leakage

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and malposition, draining the patient's urine,

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and verifying nephrostomy tube patency.

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Remove the syringe adaptor

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from the administration syringe.

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Note:

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If JELMYTO gets onto the syringe tip

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or the catheter's Luer Lock port, wipe it off immediately

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with sterile gauze so it does not solidify

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and prevent a secure connection.

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Refer to Frequently Asked Questions in the JELMYTO IFA.

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Connect the administration syringe

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to the nephrostomy tube's Luer Lock port

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by rotating the syringe only.

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Gradually instill the JELMYTO into the patient

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by turning the knob of the Uroject12 Syringe Lever

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at a rate of 1 to 2 seconds per stroke.

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The entire syringe must be emptied within 1 minute.

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Following completion of the JELMYTO administration,

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disconnect the syringe from the nephrostomy tube.

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Fill a 2.5 milliliter to 5 milliliter Luer Lock syringe

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with 2 milliliters of saline.

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Connect the syringe to the nephrostomy tube,

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and flush the nephrostomy tube.

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Note:

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Chilling the saline may help flush the nephrostomy tube.

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Disconnect the 2.5 milliliter to 5 milliliter syringe

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from the nephrostomy tube.

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Clamp and cap nephrostomy tube.

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Remove the administration syringe from the Uroject12

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by rotating the syringe barrel counterclockwise.

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Discard the administration ancillaries

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according to your facility's disposal procedures.

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Send the Uroject12 to be processed

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according to your facility's procedures

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and the Uroject12 Syringe Lever Instructions for Use.

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Provide patient education on home chemotherapy precautions

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and nephrostomy drainage supplies/adaptors

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in the event the patient requires drainage.

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Monitor patients for signs of obstruction.

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Frequently Asked Questions.

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How do I connect the syringe adaptor?

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Screw the Luer Lock end

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of the syringe adaptor onto the syringe hub

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until it is finger tight.

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How do I connect the syringe adaptor to the vial adaptor?

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Place the syringe adaptor over the vial adaptor

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and align the tabs,

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then press down firmly.

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You will hear a snap which confirms successful attachment.

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How do I disconnect the syringe adaptor

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from the vial adaptor?

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Pinch the tabs on the syringe adaptor

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to separate it from the vial adaptor.

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I am having a hard time working with reconstituted JELMYTO.

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It seems to be solidifying.

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If you are having difficulty pushing

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or withdrawing JELMYTO,

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recap and place the components back into the ice bath

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until JELMYTO liquifies.

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What should I do if there is JELMYTO spillage

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from the syringe tip?

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You will need to clean JELMYTO off the syringe tip

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and the Luer Lock port of the catheter

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to ensure the two components can connect securely.

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To clean the syringe tip,

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fold a sterile gauze pad in half twice

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and push it into the inside of the Luer Lock port

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to wipe any JELMYTO off the threads.

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To clean the Luer Lock port on the catheter,

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use a sterile gauze pad to wipe off any JELMYTO.

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Verify that the connectors are clean

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to ensure a secure connection

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between the syringe and the catheter.

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Remember, the contents of this video

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do not replace the Full Prescribing Information.

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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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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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Indications and Usage.

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JELMYTO (mitomycin) for pyelocalyceal solution

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is indicated 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 is contraindicated

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in patients with perforation of the bladder

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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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00:13:24.510 --> 00:13:28.560
of ureteric obstruction, including flank pain, and fever,

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00:13:28.560 --> 00:13:30.990
and for changes in renal function.

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00:13:30.990 --> 00:13:34.320
Patients who experience obstruction may require transient

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00:13:34.320 --> 00:13:36.360
or long-term ureteral stents

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00:13:36.360 --> 00:13:38.100
or alternative procedures.

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00:13:38.100 --> 00:13:41.130
Withhold or permanently discontinue JELMYTO

270
00:13:41.130 --> 00:13:43.983
based on the severity of ureteric obstruction.

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00:13:44.970 --> 00:13:46.650
Bone Marrow Suppression.

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00:13:46.650 --> 00:13:50.160
The use of JELMYTO can result in bone marrow suppression,

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00:13:50.160 --> 00:13:54.390
particularly thrombocytopenia and neutropenia.

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00:13:54.390 --> 00:13:56.520
The following tests should be obtained

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prior to each treatment:

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00:13:58.380 --> 00:14:00.990
Platelet count, white blood cell count

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00:14:00.990 --> 00:14:02.883
differential and hemoglobin.

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00:14:03.810 --> 00:14:05.130
Withhold JELMYTO for

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00:14:05.130 --> 00:14:08.880
Grade 2 thrombocytopenia or neutropenia.

280
00:14:08.880 --> 00:14:10.980
Permanently discontinue for Grade 3

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00:14:10.980 --> 00:14:14.313
or greater thrombocytopenia or neutropenia.

282
00:14:15.870 --> 00:14:17.763
Embryo-Fetal Toxicity.

283
00:14:18.660 --> 00:14:22.440
Based on findings in animals and mechanism of action,

284
00:14:22.440 --> 00:14:24.150
JELMYTO can cause fetal harm

285
00:14:24.150 --> 00:14:26.670
when administered to a pregnant woman.

286
00:14:26.670 --> 00:14:28.980
In animal reproduction studies,

287
00:14:28.980 --> 00:14:32.793
administration of mitomycin resulted in teratogenicity.

288
00:14:34.200 --> 00:14:36.720
Advise females of reproductive potential

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00:14:36.720 --> 00:14:40.650
to use effective contraception during treatment with JELMYTO

290
00:14:40.650 --> 00:14:43.383
and for 6 months following the last dose.

291
00:14:44.280 --> 00:14:46.740
Advise male patients with female partners

292
00:14:46.740 --> 00:14:50.340
of reproductive potential to use effective contraception

293
00:14:50.340 --> 00:14:52.200
during treatment with JELMYTO

294
00:14:52.200 --> 00:14:55.680
and for 3 months following the last dose.

295
00:14:55.680 --> 00:14:57.750
Common Adverse Reactions.

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00:14:57.750 --> 00:15:00.420
The most common adverse reactions in greater than

297
00:15:00.420 --> 00:15:03.753
or equal to 20% of patients treated with JELMYTO

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00:15:03.753 --> 00:15:06.690
were ureteric obstruction, flank pain,

299
00:15:06.690 --> 00:15:11.690
urinary tract infection, hematuria, abdominal pain, fatigue,

300
00:15:11.940 --> 00:15:15.933
renal dysfunction, nausea, dysuria, and vomiting.

301
00:15:16.890 --> 00:15:19.530
Additional Adverse Reactions Information.

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00:15:19.530 --> 00:15:22.920
Selected clinically relevant adverse reactions

303
00:15:22.920 --> 00:15:25.470
in less than 10% and greater than

304
00:15:25.470 --> 00:15:30.060
or equal to 2% of patients who received JELMYTO include

305
00:15:30.060 --> 00:15:34.290
urinary tract inflammation, bladder spasm, urosepsis,

306
00:15:34.290 --> 00:15:37.563
hypersensitivity, and instillation site pain.

307
00:15:38.850 --> 00:15:42.480
Use in Specific Populations. Lactation.

308
00:15:42.480 --> 00:15:45.570
Because of the potential for serious adverse reactions

309
00:15:45.570 --> 00:15:47.760
in a breastfed child,

310
00:15:47.760 --> 00:15:51.420
advise women not to breastfeed during treatment with JELMYTO

311
00:15:51.420 --> 00:15:54.003
and for 1 week following the last dose.

312
00:15:54.870 --> 00:15:57.573
Preparation and Administration Information.

313
00:15:58.620 --> 00:16:01.560
JELMYTO is for pyelocalyceal use only

314
00:16:01.560 --> 00:16:03.420
and not for intravenous use,

315
00:16:03.420 --> 00:16:06.213
topical use, or oral administration.

316
00:16:07.050 --> 00:16:08.670
JELMYTO must be prepared

317
00:16:08.670 --> 00:16:11.280
and administered by a healthcare provider.

318
00:16:11.280 --> 00:16:12.780
To ensure proper dosing,

319
00:16:12.780 --> 00:16:16.020
it is important to follow the preparation instructions found

320
00:16:16.020 --> 00:16:18.600
in the JELMYTO Instructions for Pharmacy

321
00:16:18.600 --> 00:16:21.090
and administration instructions found

322
00:16:21.090 --> 00:16:24.630
in the JELMYTO Instructions for Administration.

323
00:16:24.630 --> 00:16:28.290
JELMYTO may discolor urine to a violet to blue color

324
00:16:28.290 --> 00:16:30.390
following the instillation procedure.

325
00:16:30.390 --> 00:16:33.060
Advise patients to avoid contact with urine

326
00:16:33.060 --> 00:16:36.660
for at least 6 hours post instillation,

327
00:16:36.660 --> 00:16:38.970
to void urine sitting on a toilet,

328
00:16:38.970 --> 00:16:41.913
and to flush the toilet several times after use.

329
00:16:42.780 --> 00:16:45.150
JELMYTO is a hazardous drug.

330
00:16:45.150 --> 00:16:49.410
Follow applicable special handling and disposal procedures.

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00:16:49.410 --> 00:16:51.960
Please see accompanying Full Prescribing Information,

332
00:16:51.960 --> 00:16:53.430
Instructions for Pharmacy,

333
00:16:53.430 --> 00:16:55.230
and Instructions for Administration,

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00:16:55.230 --> 00:16:58.153
and Instruction Guide for instillation of JELMYTO

335
00:16:58.153 --> 00:17:01.080
(mitomycin) for pyelocalyceal solution

336
00:17:01.080 --> 00:17:03.160
with a nephrostomy tube.

337
00:17:03.160 --> 00:17:05.460
JELMYTO and UroGen are registered trademarks

338
00:17:05.460 --> 00:17:07.170
of UroGen Pharma, Limited.

339
00:17:07.170 --> 00:17:08.700
All other trademarks are the property

340
00:17:08.700 --> 00:17:10.053
of their respective owners.

341
00:17:11.160 --> 00:17:14.460
Please visit JELMYTO.com/hcp

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00:17:14.460 --> 00:17:15.723
for more information.