﻿WEBVTT

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<v Narrator>JELMYTO Instructions for Administration</v>

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for pyelocalyceal instillation 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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Read and follow this Instructions for Administration

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prior to each JELMYTO instillation.

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This video contains information

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on how to instill JELMYTO

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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,

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fatigue, 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 by a healthcare professional

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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,

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thereby, exposing the tissue to mitomycin

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over a prolonged period of time.

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JELMYTO is viscous,

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even when it is a liquid in a chilled state.

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Therefore, you will 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 Urojet12 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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or 20 degrees Celsius to 25 degrees Celsius

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for up to 96 hours or four days.

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Protect from light.

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When ready to instill, chill JELMYTO

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to 27 degrees Fahrenheit to 41 degrees Fahrenheit

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or -3 degrees Celsius to 5 degrees Celsius

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for at least 10 minutes, but no longer than one hour

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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, you will need one vial

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of reconstituted JELMYTO with a resultant concentration

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of four 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 OnGuard 2 CSTD Syringe Adaptor,

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MEDALLION COP, or MEDALLION Luer Lock syringe 20 milliliter,

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ureteral catheter with molded Luer Lock port

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5-French or 7-French.

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Urojet12 Syringe Lever.

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Note.

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The Urojet12 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

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or disinfection instructions detailed

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in the 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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or 15 milliliters, whichever is lower.

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If the kidney volume is already known, 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 a retrograde pyelogram using diluted contrast

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so that the entire renal pelvis and calyces are observed

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and contrast starts to flow

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below the ureteropelvic junction or UPJ.

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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 five minutes.

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Note.

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Do not withdraw contrast back into the syringe.

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Repeat steps one through three

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two more times for a total of three measurements

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to improve accuracy.

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Average the three volume measurements

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and round to the nearest whole number.

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This is the patient's kidney volume.

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Section B: Select the Instillation Volume.

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Select the kidney volume or 15 milliliters,

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whichever is lower, as the instillation volume.

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Note.

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Maximum instillation volume is 15 milliliters.

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Record this volume for future instillations.

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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 one hour.

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After at least 10 minutes

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advance the ureteral catheter over the guidewire

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towards the target anatomy in the pyelocalyceal system.

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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 four minutes to draw JELMYTO

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into the administration syringe before it solidifies.

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After four minutes, recap and place the components

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back in the ice bath for no more than 15 minutes

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to liquify the JELMYTO.

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Remove the JELMYTO vial

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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

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the calculated instillation volume of JELMYTO

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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

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in Section E to avoid JELMYTO solidification.

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Section E: Instill JELMYTO.

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Remove the syringe adaptor 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,

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wipe it off immediately with sterile gauze

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so it does not solidify and prevent a secure connection.

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Refer to Frequently Asked Questions

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on the Instructions for Administration for further details.

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Connect the administration syringe

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to the ureteral catheter's Luer Lock port

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by rotating the syringe only.

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Using fluoroscopy, ensure the ureteral catheter

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is in the desired anatomical position.

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Gradually instill the JELMYTO into the patient

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by turning the knob

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at a rate of one to two seconds per stroke.

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The entire syringe must be emptied within one minute.

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Remove the ureteral catheter from the urinary tract.

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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 reprocessed

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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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Frequently Asked Questions.

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How do I connect the syringe adaptor?

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Screw the Luer Lock end of the syringe adaptor

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onto the syringe hub 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

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over the vial adaptor 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 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 to ensure

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a secure connection 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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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.

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Contraindications.

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JELMYTO is contraindicated in patients

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with perforation of the bladder or upper urinary tract,

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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

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may require transient or long term ureteral stents

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or alternative procedures.

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Withhold or permanently discontinued 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

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differential and hemoglobin.

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Withhold JELMYTO

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for Grade 2 thrombocytopenia or neutropenia.

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Permanently discontinue

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for Grade 3 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

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to use effective contraception

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during treatment with JELMYTO

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and for six months following the last dose.

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Advise male patients with female partners

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of reproductive potential

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to use effective contraception during treatment with JELMYTO

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and for three months following the last dose.

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Common adverse reactions.

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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,

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fatigue, 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,

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hypersensitivity, 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,

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advise women not to breastfeed 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

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found in the JELMYTO Instructions for Pharmacy

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and administration instructions

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found 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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JELMYTO and UroGen are registered trademarks

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of UroGen Pharma Limited.

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All other trademarks are the property

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of their respective owners.

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Please visit JELMYTO.com/hcp for more information.

