Narrator: JELMYTO administration guide
for pyelocalyceal instillation with nephrostomy tube only.
Please see accompanying full prescribing information,
instructions for pharmacy,
and instructions for administration,
and instruction guide for instillation
of JELMYTO, mitomycin,
for pyelocalyceal solution with a nephrostomy tube.
Read and follow this administration guide
prior to each JELMYTO instillation.
This video contains information on how to instill JELMYTO
using the reconstituted JELMYTO vial,
which you received from the pharmacy,
and the devices listed under supplies needed
obtained by your facility.
JELMYTO, mitomycin, for pyelocalyceal solution
is indicated for the treatment of adult patients
with low-grade upper tract urothelial cancer, LG-UTUC.
The most common adverse reactions
in greater than or equal to 20% of patients
treated with JELMYTO
were ureteric obstruction, flank pain,
urinary tract infection, hematuria,
abdominal pain, fatigue, renal dysfunction,
nausea, dysuria, and vomiting.
Important information you need to know
before instilling JELMYTO.
JELMYTO must be reconstituted by a healthcare professional
prior to instillation.
Reconstituted JELMYTO will appear as a semisolid gel.
Once chilled, JELMYTO will convert
to a viscous liquid for instillation.
Once instilled into the patient's pyelocalyceal system,
JELMYTO will fill and conform to the cavity
and become a gel,
thereby exposing the tissue to mitomycin
over a prolonged period of time.
JELMYTO is viscous,
even when it is a liquid in a chilled state.
Therefore, you will need a Uroject12 syringe lever
to instill JELMYTO into the patient.
You cannot instill JELMYTO without the Uroject12 device.
Instill as soon as possible after reconstitution.
Store reconstituted JELMYTO at 68 degrees Fahrenheit
to 77 degrees Fahrenheit,
or 20 degrees Celsius to 25 degrees Celsius,
for up to 96 hours, or four days.
Protect from light.
When ready to instill,
chill JELMYTO to 27 degrees Fahrenheit
to 41 degrees Fahrenheit,
or minus three degrees Celsius to five degrees Celsius,
for at least 10 minutes,
but no longer than one hour,
to revert it to a liquid form.
See the steps A through E
for complete administration instructions.
JELMYTO is a cytotoxic anti-cancer drug.
Procedures for proper handling
and disposal of anti-cancer drugs
should be followed.
Supplies needed.
To instill JELMYTO,
you will need one vial of reconstituted JELMYTO,
with a resultant concentration
of four milligrams of mitomycin per milliliter
following reconstitution.
This will be prepared and provided by the pharmacy.
You will also need the following ancillary supplies,
which will be provided by your facility.
Do not substitute any of these components.
TEVADAPTOR Syringe adaptor
or OnGuard 2 CSTD Syringe adaptor.
MEDALLION COP or MEDALLION Luer Lock syringe, 20 milliliter.
2.5 milliliter to five milliliter syringe.
Needle for drawing up saline.
Saline.
Uroject12 syringe lever.
Note, the Uroject12 syringe lever is a multi-use device
and must be sterilized or disinfected before use.
Please follow the sterilization or disinfection instructions
detailed in the Uroject12 syringe lever
instructions for use.
An ice bath to chill the vial of JELMYTO
prior to instillation.
Section A: measure the kidney volume.
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.
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.
Record the volume of contrast injected at this point.
Allow the contrast to drain from the kidney.
This may take about five minutes.
Note, do not withdraw contrast back into the syringe.
Repeat steps one through three two more times,
for a total of three measurements to improve accuracy.
Subtract two milliliters from each measurement
prior to averaging.
Important: since the nephrostomy catheter
will be flushed with two milliliters of sterile saline,
it is critical to subtract the two milliliters
from each measurement
prior to averaging to account for the dead space.
Section B: select the instillation volume.
Select the kidney volume or 15 milliliters,
whichever is lower, as the instillation volume.
Note: maximum instillation volume is 15 milliliters.
Record this volume for future instillations.
Important information regarding nephrostomy instillation.
Note: follow practice/institutional protocol
regarding placement for a nephrostomy tube
and time allowance for healing
before proceeding with JELMYTO instillation.
Prior to administration,
implement your clinic's practice
for draining the patient's urine.
A silicon or Silastic percutaneous nephrostomy tube
with molded Luer Lock connector and locking loop
must be placed prior to instillation of JELMYTO.
Latex should not be used due to risk of rupture.
Section C: chill the JELMYTO.
Place the JELMYTO vial in the ice bath
for at least 10 minutes,
but no longer than one hour.
Section D: prepare the administration syringe.
Once the vial is removed from the ice bath,
you have four minutes
to draw JELMYTO into the administration syringe
before it solidifies.
After four minutes,
recap and place the components back in the ice bath
for no more than 15 minutes to liquify the JELMYTO.
Remove the JELMYTO vial from the ice bath and dry it off.
Swirl the vial upright
to ensure the JELMYTO is uniformly mixed.
Connect the syringe adaptor
to the 20-milliliter Luer Lock syringe.
This will be the administration syringe.
Slowly withdraw the calculated instillation volume
of JELMYTO into the administration syringe.
Press the clutch button on the Uroject12.
And pull the knob out.
Insert the administration syringe
into the Uroject12 syringe lever,
and rotate it clockwise until it locks in place.
While pressing the clutch button,
advance the lever to just above
the administration syringe's plunger.
Immediately proceed with the instillation steps in section E
to avoid JELMYTO solidification.
Section E: instill JELMYTO.
Remove the syringe adaptor from the administration syringe.
Note: if JELMYTO gets onto the syringe tip
or the catheter's Luer Lock port,
wipe it off immediately with sterile gauze
so it does not solidify and prevent a secure connection.
Refer to frequently asked questions in the JELMYTO IFA.
Connect the administration syringe
to the nephrostomy tube's Luer Lock port
by rotating the syringe only.
Gradually instill the JELMYTO into the patient
by turning the knob of the Uroject12 syringe lever
at a rate of one to two seconds per stroke.
The entire syringe must be emptied within one minute.
Following completion of the JELMYTO administration,
disconnect the syringe from the nephrostomy tube.
Fill a 2.5 milliliter to five milliliter Luer Lock syringe
with two milliliters of saline.
Connect the syringe to the nephrostomy tube,
and flush the nephrostomy tube.
Note: chilling the saline
may help flush the nephrostomy tube.
Disconnect the 2.5 milliliter to five milliliter syringe
from the nephrostomy tube.
Clamp and cap nephrostomy tube.
Remove the administration syringe from the Uroject12
by rotating the syringe barrel counterclockwise.
Discard the administration ancillaries
according to your facility's disposal procedures.
Send the Uroject12 to be processed
according to your facility's procedures
and the Uroject12 syringe lever instructions for use.
Frequently asked questions.
How do I connect the syringe adaptor?
Screw the Luer Lock end of the syringe adaptor
onto the syringe hub until it is finger tight.
How do I connect the syringe adaptor to the vial adaptor?
Place the syringe adaptor over the vial adaptor
and align the tabs,
then press down firmly.
You will hear a snap, which confirms successful attachment.
How do I disconnect the syringe adaptor
from the vial adaptor?
Pinch the tabs on the syringe adaptor
to separate it from the vial adaptor.
I am having a hard time working with reconstituted JELMYTO.
It seems to be solidifying.
If you are having difficulty pushing or withdrawing JELMYTO,
re-cap and place the components back into the ice bath
until JELMYTO liquefies.
What should I do if there is JELMYTO spillage
from the syringe tip?
You will need to clean JELMYTO off the syringe tip
and the Luer Lock port of the catheter
to ensure the two components can connect securely.
To clean the syringe tip,
fold a sterile gauze pad in half twice,
and push it into the inside of the Luer Lock port
to wipe any JELMYTO off the threads.
To clean the Luer Lock port on the catheter,
use a sterile gauze pad to wipe off any JELMYTO.
Verify that the connectors are clean
to ensure a secure connection
between the syringe and the catheter.
Remember, the contents of this video
do not replace the full prescribing information.
Please see accompanying full prescribing information,
instructions for pharmacy,
and instructions for administration,
and instruction guide for instillation
of JELMYTO, mitomycin,
for pyelocalyceal solution with a nephrostomy tube.
Indications and usage.
JELMYTO, mitomycin, for pyelocalyceal solution
is indicated for the treatment of adult patients
with low-grade upper tract urothelial cancer, LG-UTUC.
Important safety information: contraindications.
JELMYTO is contraindicated in patients
with perforation of the bladder or upper urinary tract.
Ureteric obstruction.
Ureteric obstruction, including ureteral stenosis
and hydronephrosis,
occurred in patients receiving JELMYTO.
Monitor patients for signs and symptoms
of ureteric obstruction,
including flank pain and fever,
and for changes in renal function.
Patients who experience obstruction may require transient
or long-term ureteral stents or alternative procedures.
Withhold or permanently discontinue JELMYTO
based on the severity of ureteric obstruction.
Bone marrow suppression.
The use of JELMYTO can result in bone marrow suppression,
particularly thrombocytopenia and neutropenia.
The following tests should be obtained
prior to each treatment:
platelet count,
white blood cell count differential and hemoglobin.
Withhold JELMYTO for grade two thrombocytopenia
or neutropenia.
Permanently discontinue for grade three
or greater thrombocytopenia or neutropenia.
Embryo-fetal toxicity.
Based on findings in animals and mechanism of action,
JELMYTO can cause fetal harm
when administered to a pregnant woman.
In animal reproduction studies,
administration of mitomycin resulted in teratogenicity.
Advise females of reproductive potential
to use effective contraception during treatment with JELMYTO
and for six months following the last dose.
Advise male patients
with female partners of reproductive potential
to use effective contraception during treatment with JELMYTO
and for three months following the last dose.
Common adverse reactions.
The most common adverse reactions
in greater than or equal to 20% of patients
treated with JELMYTO
were ureteric obstruction, flank pain,
urinary tract infection, hematuria, abdominal pain,
fatigue, renal dysfunction,
nausea, dysuria, and vomiting.
Additional adverse reactions information.
Selected clinically relevant adverse reactions
in less than 10%
and greater than or equal to 2% of patients
who received JELMYTO include urinary tract inflammation,
bladder spasm, urosepsis, hypersensitivity,
and instillation site pain.
Use in specific populations: lactation.
Because of the potential for serious adverse reactions
in a breastfed child,
advise women not to breastfeed during treatment with JELMYTO
and for one week following the last dose.
Preparation and administration information.
JELMYTO is for pyelocalyceal use only
and not for intravenous use,
topical use or oral administration.
JELMYTO must be prepared
and administered by a healthcare provider
To ensure proper dosing,
it is important to follow the preparation instructions
found in the JELMYTO instructions for pharmacy
and administration instructions
found in the JELMYTO instructions for administration.
JELMYTO may discolor urine to a violet to blue color
following the instillation procedure.
Advise patients to avoid contact with urine
for at least six hours post-instillation,
to void urine sitting on a toilet,
and to flush the toilet several times after use.
JELMYTO is a hazardous drug.
Follow applicable special handling and disposal procedures.
Please see accompanying full prescribing information,
instructions for pharmacy,
and instructions for administration,
and instruction guide
for instillation of JELMYTO, mitomycin,
for pyelocalyceal solution with a nephrostomy tube.
JELMYTO and UroGen are registered trademarks
of UroGen Pharma, Limited.
All other trademarks are the property
of their respective owners.
Please visit JELMYTO.com/hcp for more information.