Narrator: JELMYTO Instructions for Pharmacy.
Please see accompanying Full Prescribing Information,
Instructions for Pharmacy,
and Instructions for Administration.
This video contains information
on how to prepare JELMYTO
using pharmacy supplies and a Chilling Block.
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 reconstituting JELMYTO.
Once reconstituted with sterile hydrogel,
JELMYTO will appear as a semisolid gel.
Once chilled, JELMYTO will convert to a viscous liquid.
Reconstituted JELMYTO must be prepared
under chilled conditions.
A Chilling Block can be used for this purpose.
JELMYTO cannot be prepared without the Chilling Block
or other means of chilling.
Preparation of JELMYTO must be performed
under aseptic conditions.
Storage conditions and handling.
Instill the JELMYTO solution
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.
JELMYTO is a cytotoxic anti-cancer drug.
Procedures for proper handling and disposal
of anti-cancer drugs should be followed.
Supplies needed.
To reconstitute JELMYTO,
you will need the following supplies.
JELMYTO Kit containing two vials of mitomycin
for Pyelocalyceal Solution 40 milligrams per vial.
One vial Sterile Hydrogel 20 milliliters per vial.
One JELMYTO Admixture Label.
JELMYTO full Prescribing Information, PI.
JELMYTO Instructions for Pharmacy, IFP.
JELMYTO Instructions for Administration, IFA.
Pharmacy supplies will be provided by your facility.
They include three TEVADAPTOR
or OnGuard 2 CSTD Vial Adaptors.
Three TEVADAPTOR or OnGuard 2 CSTD Syringe Adaptors.
One Luer Lock connector.
Two 10 milliliter Luer Lock syringes.
One 20 milliliter Luer Lock syringe.
One 20 to 25 gauge needle for drawing up sterile water.
Two milliliters sterile water.
70% isopropyl alcohol or equivalent.
One Light protective bag.
One Chilling Block.
Note.
The day before your preparation,
put the Chilling Block in the freezer
-: 4 degrees Fahrenheit to 10.4 degrees Fahrenheit
or -20 degrees Celsius to -12 degrees Celsius overnight.
Please refer to the Chilling Block Instructions for Use
for more information.
Section A: Freeze Chilling Block.
The day before preparation,
put the Chilling Block in the freezer.
-: 4 degrees Fahrenheit to 10.4 degrees Fahrenheit
or -20 degrees Celsius to -12 degrees Celsius overnight.
Note.
Please refer to the Chilling Block Instructions for Use
for additional information.
Section B: Prepare supplies.
Remove the Chilling Block from the freezer.
Disinfect the Chilling Block
with 70% isopropyl alcohol or equivalent.
As per your pharmacy's policy, allow it to air dry
and then place it upright inside the hood or isolator.
Wait 20 minutes before continuing.
Connect vial adaptors to all three vials.
Connect a syringe adaptors
to one of the 10 milliliter syringes.
Connect a syringe adaptors to the 20 milliliter syringe.
Place the three vials, the 10 milliliter syringe
and the 20 milliliter syringe into the Chilling Block
for at least 10 minutes.
While the vials and syringes are in the Chilling Block,
withdraw two milliliters of sterile water
into the other 10 milliliter syringe
and set aside for later use.
Section C: Create Pre-Wetting Solution.
Slowly fill the chilled 20 syringe
with 14 milliliters of sterile hydrogel.
Recap the chilled 20 milliliter syringe
and place it in the Chilling Block.
Slowly fill the chilled 10 milliliter syringe
with four milliliters of sterile hydrogel.
Discard the unused portion of sterile hydrogel.
Replace the needle on two milliliters sterile water syringe
with a Luer Lock connector.
Remove the syringe adaptor
from the four milliliter sterile hydrogel syringe.
Connect the four milliliter sterile hydrogel syringe
to the other side of the Luer Lock connector
on the two milliliter sterile water syringe.
Gently mix the sterile water with a sterile hydrogel
by pushing the plungers back and forth at least 25 times
to create the Pre-Wetting Solution or PWS.
Transfer the six milliliter Pre-Wetting Solution
into one of the syringes.
Replace the Luer Lock connector
on the six milliliter Pre-Wetting Solution syringe
with a new syringe adaptor.
Place the six milliliter Pre-Wetting Solution syringe
in the Chilling Block.
Section D: Mix the admixture.
Remove both JELMYTO vials from the Chilling Block.
Gently tap the bottom of each vial on the table
to ensure all the mitomycin powder
is at the bottom of the vials.
Remove the chilled six milliliter
Pre-Wetting Solution syringe from the Chilling Block.
Inject three milliliters of Pre-Wetting Solution
into each JELMYTO vial.
Note.
To ensure accurate dosing,
the contents of each vial must be the same.
Discard the empty Pre-Wetting Solution syringe.
Gently swirl each JELMYTO vial upright at least 15 times,
ensuring all powder and admixture is contained
at the bottom of the vial.
Note.
Do not invert or shake the vials.
On average, pharmacy partners report 45 to 60 minutes
for the reconstitution of JELMYTO.
Individual times may vary.
Immediately remove
the chilled 14 milliliter sterile hydrogel syringe
from the Chilling Block.
Immediately inject seven milliliters of sterile hydrogel
into each JELMYTO vial.
Note.
To ensure accurate dosing,
the contents of each vial must be the same.
Gently swirl each JELMYTO vial upright at least 15 times,
ensuring all admixture is contained
at the bottom of the vial.
Note.
Do not invert or shake the vials.
Recap and replace the 20 milliliter syringe
in the Chilling Block.
Mix the JELMYTO admixture vials.
Recap and place both JELMYTO vials in the Chilling Block
for five minutes.
Remove both vials.
And vigorously swirl them upright at least 15 times,
ensuring all admixture is contained
at the bottom of the vials.
Place both vials back in the Chilling Block.
Repeat these steps every five minutes
for a total of 30 minutes.
Note.
Do not invert or shake the vials.
Section E: Prepare admixture vial.
Remove one JELMYTO vial from the Chilling Block.
Vigorously swirl the vial upright at least 15 times.
Note.
Do not invert or shake the vial.
Using the chilled 20 milliliter syringe,
slowly withdraw seven milliliters of admixture
from the vial.
Note.
If you are having difficulty withdrawing the admixture,
place the components back in the Chilling Block
until the admixture liquefies again.
Discard the empty JELMYTO vial.
Remove the remaining JELMYTO vial from the Chilling Block.
Inject the contents
of the 20 milliliter syringe into that vial.
Now all the admixture is contained in one vial,
recap the vial adaptor.
Vigorously swirl the vial upright at least 15 times.
Note.
Do not invert or shake the vial.
Your JELMYTO admixture vial is now complete
with a result in concentration
of four milligrams of mitomycin per milliliter
following reconstitution.
Section F: Dispense admixture vial.
Write the discard after date and time
on the supplied admixture label
and apply it to the prepared JELMYTO admixture vial.
You may also substitute your pharmacy's label
for dispensing the admixture.
Note.
The discard after date and time is 96 hours or four days
from the completion of the preparation at room temperature.
Place the JELMYTO, a mixture vial
in a light-protective back.
Transport to the treatment facility
along with the JELMYTO Instructions for Administration.
Important information to remember.
When preparing JELMYTO for instillation,
there are some important things to remember.
All components must be kept cold
during the preparation process
by placing them in the Chilling Block
when they're not in use.
If you have difficulty pushing the solution
or withdrawing the solution at any time,
put the components back in the Chilling Block
until the product liquifies.
Frequently asked questions.
How do I connect the vile adaptor?
Place the vile adaptor over the vial and press down firmly.
You will hear a snap which confirms successful attachment.
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.
Do I need to put the caps on the syringes and vials
before placing them back into the Chilling Block?
Yes, the Chilling Block inserts are not sterile.
It is important to maintain aseptic technique.
Do I have to keep the vials upright when mixing?
If so, why?
Yes, the vials should be upright during all mixing
to ensure the contents are fully mixed
at the bottom of the vial.
I am having difficulty working with the drug product.
It seems to be solidifying.
If you are having difficulty pushing the solution
or withdrawing the solution,
place the components back into the Chilling Block
until the product liquifies.
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.
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 discontinued 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 2 thrombocytopenia
or neutropenia.
Permanently discontinue
for Grade 3 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.
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.