(mysterious music)
Announcer: Jelmyto: Rising to the challenge
of the renal anatomy.
Introducing Jelmyto, the first and only
FDA-approved treatment indicated for the treatment
of low-grade upper tract urothelial cancer
in adult patients.
Jelmyto combines the anti-tumor activity of mitomycin
with the innovative delivery mechanism of RTGel,
reverse-thermal hydrogel, to make chemoablation
a possibility in the upper tract.
Jelmyto possesses unique, dynamic reverse-thermal properties
that cause it to exist as a liquid at lower temperatures
and convert to gel form at body temperature,
providing a first-of-its-kind treatment
for sustained exposure of a chemoablative drug
in the renal pelvis.
Jelmyto is chilled and administered via a ureteral catheter
into the pyelocalyceal system.
While in liquid form, Jelmyto fills and conforms
to the hard-to-reach areas of the renal pelvis.
As Jelmyto reaches body temperature,
it forms a semisolid gel, coating both resectable
and unresectable tumors.
Jelmyto stays in the collecting system long enough
to chemoablate tumors without being washed away,
providing up to four to six hours
of sustained exposure to mitomycin.
Over the course of a few hours, Jelmyto gradually dissolves
and is excreted via normal urine flow.
(gentle upbeat music)
Jelmyto offers the convenience
of same-day outpatient administration.
Jelmyto: Every patient deserves a chance
to spare their kidney for tomorrow.
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 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 6 months
following the last dose.
Advise male patients with female partners
of reproductive potential to use effective contraception
during treatment with Jelmyto
and for 3 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.
(gentle upbeat music continues)
Please visit Jelmyto.com/hcp for more information.