(Mitomycin) for Pyelocalyceal Solution with a Nephrostomy Tube

INSTRUCTION GUIDE for Instillation of JELMYTO® (mitomycin) for pyelocalyceal solution with a Nephrostomy Tube

Important Information Please refer to the FDA-approved Prescribing Information and Instructions for Administration (IFA) for information about JELMYTO. JELMYTO is a cytotoxic drug. Follow applicable special handling and disposal procedures. This Instruction Guide contains supplemental information on how to instill JELMYTO via a nephrostomy tube. These instructions are derived from materials from the OLYMPUS Clinical Trial. It is important to note that in the OLYMPUS Clinical Trial, no investigators utilized a nephrostomy tube as the mode of administration. Important Information Regarding Nephrostomy Instillation Note: Follow practice/institutional protocol regarding placement for nephrostomy tube and time allowance for healing before proceeding with JELMYTO instillation. • Prior to administration, implement your clinic's practice for draining the patients' urine. • A Silicon or Silastic percutaneous nephrostomy tube with molded Luer lock connector and locking loop must be placed prior to installation of JELMYTO. Latex should not be used, due to risk of rupture.

Instillation Instructions A. Measure the Kidney Volume Before the First Instillation The Instillation Volume will be equal to the patient’s kidney volume. If the kidney volume is already known, proceed to Section B. If the kidney volume is NOT known, or needs to be reassessed, use the following steps: 1. Perform an antegrade pyelogram using diluted contrast (50%) so that the entire renal pelvis and calyces are observed and contrast starts to flow below the ureteropelvic junction (UPJ). 2. Record the volume of contrast injected at this point. 3. Allow the contrast to drain from the kidney. This may take about five minutes. Note: Do not withdraw contrast back into the syringe. 4. Repeat Steps 1 through 3 two more times, for a total of three measurements to improve accuracy. 5. Subtract 2 mL from each measurement prior to averaging to account for dead space.

IMPORTANT: When measuring volume using nephrostomy, subtract 2 mL from each measurement prior to averaging to account for the internal volume in the nephrostomy catheter (since catheter will be flushed with 2 mL of sterile saline).

6. Select the kidney volume OR 15 mL, whichever is lower, as the Instillation Volume. Note: Maximum Instillation Volume is 15 mL. Record the volume for future instillations.

Sections B and C on next page.

Please click here for Full Prescribing Information, Instructions for Pharmacy and Instructions for Administration. Instillation Instructions

5 Press the “Clutch” button on the Uroject12 and pull A MEASURE THE KIDNEY VOLUME C CHILL THE JELMYTO the knob out. E INSTILL JELMYTO

1 Place the JELMYTO vial 1 Remove the syringe adaptor from the administration syringe. The Instillation Volume will be equal to the in the ice bath for at Instillation Instructions least 10 minutes, but patient’s kidney volume. If the kidney volume Note: If JELMYTO gets on to the syringe tip or the no longer than one is already known, proceed to Section B. catheter’s Luer Lock port, wipe it off immediately 5 Press the “Clutch”hour. button on the Uroject12® and pull with sterile gauze so it does not solidify and prevent A MEASURE THE KIDNEY VOLUME C CHILL THE JELMYTO the knob out. E INSTILL JELMYTO INSTRUCTION GUIDE for InstillationIf the kidney volume is NOT known, or needs of JELMYTO (mitomycin) Clutch a secure connection. (Refer to Frequently Asked to be reassessed, use the following steps: Questions below for further details.) 2 After at least 10 minutes, advance the ureteral for pyelocalyceal solution with a Nephrostomycatheter over the guidewire Tube towards the target 2 Connect the administration syringe to the ureteral 1 Place the JELMYTO vial 1 Remove the syringe adaptor from the administration 1 Perform a retrograde pyelogram using diluted anatomy in the pyelocalyceal system. 6 Insert the administration syringe into the Uroject12 in the ice bath for at syringe. catheter’s Luer Lock port, by rotating the syringe only. The Instillation Volume will be equal to the contrast (50%) so that the entire renal pelvis and Syringe Lever and rotate it clockwise until it locks in least 10 minutes, but patient’s kidney volume. If the kidney volume calyces are observed and contrast starts to flow below Note: If JELMYTOplace. gets on to the syringe tip or the 3 Using fluoroscopy, ensure the ureteral catheter is in no longer than one is already known, proceed to Section B. the ureteropelvic junction (UPJ). catheter’s Luer Lock port, wipe it off immediately the desired anatomical position. hour. with sterile gauze so it does not solidify and prevent 2 Record the volume of contrast injected at this point. 4 Gradually instill the JELMYTO into the patient by If the kidney volume is NOT known, or needs PREPAREClutch THE ADMINISTRATION SYRINGEa secure connection. (Refer to Frequently Asked D turning the knob at a rate of 1-2 seconds per stroke. to be reassessed, use the following steps: Questions below for further details.) B. Chilling JELMYTO and 2 Afterpreparing at least3 Allow 10 min theutes contrast, advance to drainthe the fromureteral the Administrationkidney. This may Syringe The entire syringe must be emptied within one catheter overtake the guidewireabout five towardsminutes. the target 2 Connect the administration syringe to the ureteral minute. 1 Perform a retrograde pyelogram using diluted anatomy in the pyelocalyceal system. 6 Insert the Onceadministration the vial is syringe removed into the Uroject12 Note: Do not withdraw contrast back into the syringe. catheter’s Luer Lock port, by rotating the syringe only. Pleasecontrast (50%) refer so that the to entire Sections renal pelvis and C and D from the JELMYTO InstructionsSyringe Leverfrom and thefor rotateice bath, Administration it clockwise you have until it locks in (IFA) (pictured below). place. Instillation Instructions calyces are observed and contrast starts to flow below 4 Repeat Steps 1 through 3 two more times, for a total 4 minutes to draw JELMYTO 3 Using fluoroscopy, ensure the ureteral catheter is in the ureteropelvic junction (UPJ). of three measurements to improve accuracy. into the administration the desired anatomical position. Instillation Instructions 5 Press the “Clutch” button on the Uroject12 and pull syringe before it solidifies. 2 Record the volume of contrast injected at this point. PREPARE5 Average THE ADMINISTRATION the three volume measurements SYRINGE and round 4 Gradually instill the JELMYTO into the patient by A MEASURE THE KIDNEY VOLUME C CHILL THE JELMYTO theD knob out. E INSTILL5 Press JELMYTO the “Clutch” button on the Uroject12 and pull 7 While pressing the “Clutch” button, advance the lever to the nearest whole number. This is the patient’s turning the knob at a rate of 1-2 seconds per stroke. 3 Allow the MEASUREcontrast to drain THE from KIDNEY the kidney. VOLUME This may CHILL THE JELMYTO theAfter knob 4 ominutes,ut. recap and INSTILLto just above JELMYTO the administration syringe’s plunger. A C kidney volume. TheE entire syringe must be emptied within one take about five minutes. place the components back minute. in the ice bath for no more 1 Place the JELMYTO vial Once the vial is removed 1 Remove the syringe adaptor from the administration Note: Do not withdraw contrast back into the syringe. than 15 minutes to liquify the in the ice bath for at from the ice bath, you have syringe. 1 The Instillation Volume will be equal to the 1 Place the JELMYTO vial JELMYTO. Remove the syringe adaptor from the administration least4 Repeat10 minutes, Steps but1 through 3 two more times, for a total 4 minutes to draw JELMYTO syringe. patient’s kidney volume. If the kidney volume The Instillation Volume will be equal to the in the ice SELECTbath for atTHE INSTILLATION VOLUME Note: If JELMYTO gets on to the syringe tip or the Clutch 5 Remove the ureteral catheter from the urinary tract. no longerof three than measurements one to improve accuracy. into the administrationB is already known, proceed to Section B. patient’s kidney volume. If the kidney volume least 10 minutes, but catheter’s Luer Lock port, wipe it off immediately hour. syringe before it solidifies. Note: If JELMYTO gets on to the syringe tip or the 6 Remove the administration syringe from the Uroject12 5 Average theis already three volume known, measurements proceed to Section and round B. no longer than one with sterile gauze so it does not solidify and prevent 7 1 Remove the JELMYTO vial from the ice bath and dry catheter’s Luer Lock port, wipe it off immediately by rotating the syringe barrel counter-clockwise. If the kidney volume is NOT known, or needs hour.Clutch While pressing the “Clutch” button, advance the lever to the nearest whole number. This is the patient’s a secure connection. (Refer to Frequently Asked with sterile gauze so it does not solidify and prevent After 4 minutes, recap and to just above itthe off. administration syringe’s plunger. to be reassessed, use the following steps: kidney volume.If the kidney volume is NOT known, or needs 1 Select the kidney volume OR 15 mL, whichever is Questions below for further details.)Clutch 2 After at least 10 minutes, advance the ureteral place the components back a secure connection. (Refer to Frequently Asked 7 Discard the administration ancillaries according to to be reassessed, use the following steps: lower, as the Instillation Volume. 2 Swirl the vial upright to ensure that JELMYTO is catheter over the guidewire towards the target in the ice2 bathAfter for at no least more 10 minutes, advance the ureteral Questions below for further details.) your facility’s disposal procedures. 2 Connect the administrationuniformly syringemixed. to the ureteral 1 Perform a retrograde pyelogram using diluted anatomy in the pyelocalyceal system. 6 Insertthan the 15 administrationminutes to liquify syringe the into the Uroject12 catheter Note: over Maximum the guidewire Instillation towards Volume the target is 15 mL. catheter’s Luer Lock port, by rotating the syringe only. 2 Connect the administration syringe to the ureteral 8 Send the Uroject12 to be reprocessed according to contrast (50%) so that the entire renal pelvis and SyringeJELMYTO. Lever and rotate it clockwise until it locks in 6 Insert the administration syringe into the Uroject12 1 Perform a retrograde pyelogram using diluted anatomyRecord in the this pyelocalyceal volume for future system. instillations. 3 Connect the syringe adaptor to the 20 mL Luer Lock catheter’s Immediately Luer Lock proceed port, by rotatingwith the the instillation syringe only. steps in your facility’s procedures and the Uroject12 Syringe calyces are observed and contrast starts to flow below place. 3 Using fluoroscopy,Syringe ensure Lever theand ureteral rotate it catheter Clutchclockwise is inuntil it locks in 5 Remove the ureteral catheter from the urinary tract. SELECTcontrast THE (50%) INSTILLATION so that the entire renalVOLUME pelvis and syringe. This will be the administration syringe. Section E to avoid JELMYTO solidification. Lever Instructions for Use. B the desired anatomical position. Please see accompanying Full the ureteropelvic junction (UPJ). calyces are observed and contrast starts to flow below place. 3 Using fluoroscopy, ensure the ureteral catheter is in 4 Slowly withdraw the calculated Instillation Volume of6 Remove the administration syringe from the Uroject12 Prescribing Information for JELMYTO. the ureteropelvic junction (UPJ). 1 Remove the JELMYTO vial from the ice bath and dry the desired anatomical position. 2 Record the volume of contrast injected at this point. PREPARE THE ADMINISTRATION SYRINGE 4 Gradually instill theJELMYTO JELMYTO into into the the administration patient by syringe. by rotating the syringe barrel counter-clockwise. D it off. turning the knob at a rate of 1-2 seconds per stroke. JELMYTO is a trademark of 2 Record the volume of contrast injected at this point. 4 Gradually instill the JELMYTO into the patient by 3 Allow the contrast to drain from the kidney. This may 1 Select the kidney volume OR 15 mL, whichever is D PREPARE THE ADMINISTRATION SYRINGE 7 Discard the administration ancillaries according to UroGen Pharma, Ltd. The entire syringe must be emptied within one turning the knob at a rate of 1-2 seconds per stroke. Turn Over for More Information lower, as the Instillation Volume. 2 Swirl the vial upright to ensure that JELMYTO is your facility’s disposal procedures. All other trademarks are the take about five minutes. 3 Allow the contrast to drain from the kidney. This may minute. The entire syringe must be emptied within one uniformly mixed. property of their respective owners. Once the vial is takeremoved about five minutes. Note: Do not withdraw contrast back into the syringe. Note: Maximum Instillation Volume is 15 mL. 8 Send theminute. Uroject12 to be reprocessed according to from theRecord ice bath, this you volume have for future instillations. 3 ConnectOnce the the syringe vial is removed adaptor to the 20 mL Luer Lock Note: Do not withdraw contrast back into the syringe. Immediately proceed with the instillation steps in your facility’s procedures and the Uroject12 Syringe © 2020 UroGen Pharma, Inc. 4 Repeat Steps 1 through 3 two more times, for a total 4 minutes to draw JELMYTO syringe. This will be the administration syringe. from the ice bath, you have Section E to avoid JELMYTO solidification. Lever Instructions for Use. Please see accompanying Full All rights reserved. of three measurements to improve accuracy. into the administration4 Repeat Steps 1 through 3 two more times, for a total 4 minutes to draw JELMYTO US-JEL-00074 4 Slowly withdraw the calculated Instillation Volume of Prescribing Information for JELMYTO. syringe before itof solidifies. three measurements to improve accuracy. into the administration 5 Average the three volume measurements and round JELMYTO into the administration syringe. 7 While pressingsyringe the before “Clutch” it solidifies. button, advance the lever JELMYTO is a trademark of to the nearest whole number. This is the patient’s After 4 minutes,5 Averagerecap and the three volume measurements and round to just above the administration syringe’s plunger. 7 While pressing the “Clutch” button, advance the lever UroGen Pharma, Ltd. kidney volume. place the componentsto the nearest back whole number. This is the patient’s Turn Over for More Information After 4 minutes, recap and to just above the administration syringe’s plunger. All other trademarks are the in the ice bath forkidney no more volume. place the components back property of their respective owners. than 15 minutes to liquify the in the ice bath for no more © 2020 UroGen Pharma, Inc. JELMYTO. than 15 minutes to liquify the All rights reserved. SELECT THE INSTILLATION VOLUME Clutch 5 Remove the ureteral catheter from the urinary tract. B JELMYTO. US-JEL-00074 Clutch 5 Remove the ureteral catheter from the urinary tract. B SELECT THE INSTILLATION VOLUME 6 Remove the administration syringe from the Uroject12 1 Remove the JELMYTO vial from the ice bath and dry C. Instill JELMYTO by rotating the syringe barrel counter-clockwise. 6 Remove the administration syringe from the Uroject12 it off. 1 Remove the JELMYTO vial from the ice bath and dry 1 Select the kidney volume OR 15 mL, whichever is by rotating the syringe barrel counter-clockwise. it off. 7 Discard the administration ancillaries according to lower, as the Instillation Volume. 2 Swirl the vial upright to ensure that JELMYTO is 1 Select the kidney volume OR 15 mL, whichever is your facility’s disposal procedures. 7 Discard the administration ancillaries according to uniformlyRemove mixed.lower, as the theInstillation syringe Volume. adaptor 2 from Swirl the vial uprightthe to ensureadministration that JELMYTO is syringe. Note: Maximum Instillation Volume is 15 mL. 1. your facility’s disposal procedures. uniformly mixed. 8 Send the Uroject12 to be reprocessed according to Record this volume for future instillations. 3 Connect the syringe adaptor to the 20 mL Luer Lock Note: Maximum Instillation Volume is 15 mL. Immediately proceed with the instillation steps in your facility’s procedures and the Uroject12 Syringe 8 Send the Uroject12 to be reprocessed according to syringe.Note: This will beIf the JELMYTO administration syringe. gets on to the syringe tip or the catheter’s Luer Lock port, wipe it off immediately with sterile Record this volume for future instillations. Section E3 to Connectavoid JELMYTO the syringe solidification. adaptor to the 20 mL Luer Lock Lever Instructions Immediately for Use. proceed with the instillation steps in Please see accompanyingyour facility’s procedures Full and the Uroject12 Syringe syringe. This will be the administration syringe. 4 Slowlygauze withdraw the so calculated it does Instillation Volumenot of solidify and prevent a secure connection.Section (Refer E to avoid to JELMYTO Frequently solidification. AskedPrescribing InformationLeverQuestions Instructions for JELMYTO. for Use. in the Please see accompanying Full JELMYTO into the administration syringe. 4 Prescribing Information for JELMYTO. JELMYTO IFA). Slowly withdraw the calculated Instillation Volume of JELMYTO is a trademark of JELMYTO into the administration syringe. UroGen Pharma, Ltd. Turn Over for More Information JELMYTO is a trademark of All other trademarks are the UroGen Pharma, Ltd. Turn Over for More Information property of their respective owners. All other trademarks are the property of their respective owners. 2. Connect the administration syringe to the nephrostomy tube’s Luer Lock© 2020 UroGenport, Pharma, Inc.by rotating the All rights reserved. © 2020 UroGen Pharma, Inc. syringe only. US-JEL-00074 All rights reserved. US-JEL-00074 3. Gradually instill the JELMYTO into the patient by turning the knob of the Uroject12 Syringe Lever at a rate of 1-2 seconds per stroke. The entire syringe must be emptied within one minute. 4. Following completion of the JELMYTO administration, disconnect the syringe from the nephrostomy tube. 5. Fill a 2.5 mL – 5 mL Luer lock syringe with 2 mL of saline, connect the syringe to the nephrostomy tube, and flush the nephrostomy tube. Note: Chilling the saline may help flush the nephrostomy tube.

6. Disconnect the 2.5 mL – 5 mL syringe from the nephrostomy tube. 7. Clamp and cap nephrostomy tube. 8. Remove the administration syringe from the Uroject12 by rotating the syringe barrel counterclockwise. 9. Discard the administration ancillaries according to your facility’s disposal procedures. 10. Send the Uroject12 to be processed according to your facility’s procedures and the Uroject12 Syringe Lever Instructions for Use.

Please click here for Full Prescribing Information, Instructions for Pharmacy and Instructions for Administration.