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JELMYTO mitomycin Kit — NDC 72493-103-03 (Billing 72493-0103-03)

by UroGen Pharma, Inc. · 1 KIT in 1 CARTON * 20 mL in 1 VIAL, SINGLE-DOSE * 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

This is a package of JELMYTO mitomycin Kit from UroGen Pharma, Inc., marketed since May 2020 and currently FDA-listed. It is this product's only package size.

NDC 72493-0103-03
🏷️ FDA NDC (as labeled) 72493-103-03 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 72493-103-03 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
72493 labeler · 103 product · 03 package
Package marketed since
May 1, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7249310303 3
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72493-103-03
Product NDC 72493-103
11-digit billing NDC 72493010303
NCPDP billing unit EA — each (per item)
RxCUI 2375818, 2375823
Application # NDA211728
SPL Set ID 3d3d5053-5427-4a68-a40b-edb60699521e
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-05-01
Dosage form KIT

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 21200050006430
GPI class Jelmyto
GCN Seq No 080968
GCN 47956
HICL code 003917
Ingredient (HICL) Mitomycin
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1D
Therapeutic class — specific (HIC3) Antibiotic Antineoplastics
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name JELMYTO SINGLE-DOSE KT(40MGX2)
FDB brand name Jelmyto
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 080968
  • GCN: 47956
  • GPI-14 (Medi-Span): 21200050006430
  • HICL (First Databank): 003917
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 2375818
Why two NDCs? The FDA registers this code as 72493-103-03 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 72493-0103-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Alkylating Drug class.

Pharmacologic class Alkylating Drug
Drug family (ATC) Other cytotoxic antibiotics
How it works Alkylating Activity
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name JELMYTO SINGLE-DOSE KT(40MGX2) Ingredient Mitomycin
📗 Our plain-language guide HelloPharmacist
  • The injection form, sold as Mitomycin or Mutamycin, is used with other chemotherapy drugs for stomach or pancreatic cancer that has spread. It can also be used for palliative care...
  • The injection goes into a vein through an IV catheter. A healthcare professional with chemotherapy experience gives it. Treatments are spaced several weeks apart, once your blood c...
  • The most common is low blood counts, which is why you will have regular blood tests. Nausea, vomiting, and tiredness can also occur. Your team will adjust the plan if your counts d...
  • Call for fever, chills, or other signs of infection. Also call for unusual bleeding or bruising, much less urine, or swelling. Pain, redness, or skin damage where the IV was placed...
📖 Read our full Mitomycin guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J9281 $329.937 / J9281 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)72493-103-03
11-digit billing NDC72493-0103-03
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ9281
DescriptorMitomycin pyelocalyceal instillation, 1 mg
Billing units / pkg80 units
How the units are derivedThis package is 1; the HCPCS unit is 1 MG, so one package = 80 billing units.
Medicare Part B spend (2026 (Q1))$7,137,420 · 296 claims · $24,112.90 per claim (all NDCs under J9281)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
72493-0103-03 You're viewing this Main listing 1 KIT in 1 CARTON * 20 mL in 1 VIAL, SINGLE-DOSE * 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2020-05-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Jelmytothis 72493-0103-03 UroGen 1 kit — — FDA listed —
Mitosol 49771-0002-03 Mobius 1 kit — — FDA listed —
Zusduri 72493-0106-03 UroGen 1 kit — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2020
First FDA approval
Apr 2020
📍
2026
Currently FDA-listed
6 years listed
🛡️
2031
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jan 2031. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Apr 15, 2020 RLD RS ⏳ ~4.3 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 12268745 — method of use (U-4172)
US 9950069 — drug product
US 9040074 — drug product
Exclusivity ODE-289
2020 2022 2024 2026 2028 2030
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (3)
PatentTypeUse codeExpires
US 12268745 ↗ Method of use U-4172 Jan 20, 2031
US 9950069 ↗ Drug product — Jan 20, 2031
US 9040074 ↗ Drug product — Jan 20, 2031
FDA exclusivity
CodeWhat it grantsExpires
ODE-289Orphan Drug Exclusivity (7-year)Apr 15, 2027
Common questions
Is there a generic version of JELMYTO SINGLE-DOSE KT(40MGX2)?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for JELMYTO SINGLE-DOSE KT(40MGX2). Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jan 2031 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerUroGen Pharma, Inc.
Application holderUROGEN PHARMA LTD
FDA applicationNDA211728 (NDA)
Labeler code72493
First marketedMay 2020
Product typeHuman Prescription Drug

More NDCs from UroGen Pharma, Inc. labeler code 72493

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 43 words ▾

1 INDICATIONS AND USAGE JELMYTO ® is indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC). JELMYTO is an alkylating drug indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC). ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION JELMYTO is for pyelocalyceal use only and not for intravenous use, topical use, or oral administration. ( 2.1 ) Administer 1.3 g of sodium bicarbonate orally the evening prior to, the morning of, and 30 minutes prior to instillation procedure (total of 3.9 g). ( 2.1 ) The dose of JELMYTO to be instilled is 4 mg per mL via ureteral catheter or nephrostomy tube, with total instillation volume based on volumetric measurements using pyelography, not to exceed 15 mL (60 mg of mitomycin).

( 2.2 ) Instill JELMYTO once weekly for six weeks. For patients with a complete response 3 months after JELMYTO initiation, JELMYTO instillations may be administered once a month for a maximum of 11 additional instillations. ( 2.2 )

2.1Important Administration Instructions See the Instructions for Administration provided separately. JELMYTO is for pyelocalyceal use only. JELMYTO is not for intravenous use, topical use, or oral administration.

Prior to every instillation, instruct the patient to take 1.3 g of sodium bicarbonate orally the evening prior to, the morning of, and 30 minutes prior to the instillation procedure (total of 3.9 g). General anesthesia, local anesthesia, sedation, prophylactic antibiotics and/or antihistamines may be used at the discretion of the treating urologist. If the patient is to be anesthetized, advise the patient not to take sodium bicarbonate within 30 minutes prior to the treatment.

Consider withholding diuretics one day prior to instillation until 4 hours post-instillation. When instilling JELMYTO, the entire syringe must be emptied within one minute. Advise patients that 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.

2.2Recommended Dosage The dose of JELMYTO to be instilled is 4 mg per mL via ureteral catheter or a nephrostomy tube, with total instillation volume based on volumetric measurements using pyelography, not to exceed 15 mL (60 mg of mitomycin). Instill JELMYTO once weekly for six weeks. For patients with a complete response 3 months after JELMYTO initiation, JELMYTO instillations may be administered once a month for a maximum of 11 additional instillations.

2.3Preparation and Handling See the Instructions for Pharmacy for preparation provided separately. JELMYTO is a hazardous drug. Follow applicable special handling and disposal procedures.

1 JELMYTO must be prepared under chilled conditions. Once reconstituted , the admixture will have a concentration of 4 mg of mitomycin per mL and will appear as a viscous liquid for instillation. Reconstituted JELMYTO has reverse thermal properties with a gelation point of approximately 19°C (66°F).

Reconstituted JELMYTO should be instilled as soon as possible after reconstitution. Store reconstituted JELMYTO at 20°C to 25°C (68°F to 77°F) for up to 96 hours (4 days). JELMYTO will appear as a semisolid gel when stored under these conditions.

Protect reconstituted JELMYTO from light. JELMYTO must be instilled as a chilled solution using a Uroject12 Lever, a Luer Lock syringe, and a ureteral catheter with molded Luer Lock connector. Once chilled at -3°C to 5°C (27°F to 41°F), JELMYTO will convert to a viscous liquid for instillation and is stable for up to 1 additional hour.

Reconstituted JELMYTO must be instilled within 1 hour after it is converted to a viscous liquid.

💊 Dosage Forms and Strengths 104 words ▾

3 DOSAGE FORMS AND STRENGTHS For pyelocalyceal solution: A kit containing the following: Two 40 mg (each) single-dose vials of sterile, lyophilized, grey to greyish-purple, cake or powder of mitomycin for pyelocalyceal solution One single-dose vial of 20 mL of sterile, clear, colorless gel with or without bubbles at room temperature or clear, colorless liquid at 2°C to 8°C (36°F to 46°F), to be used as a vehicle for reconstitution For pyelocalyceal solution: A kit containing the following: Two 40 mg (each) single-dose vials of mitomycin for pyelocalyceal solution ( 3 ) One vial of 20 mL sterile hydrogel for reconstitution ( 3 )

⛔ Contraindications 27 words ▾

4 CONTRAINDICATIONS JELMYTO is contraindicated in patients with perforation of the bladder or upper urinary tract. Perforation of the bladder or upper urinary tract. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Ureteric Obstruction: Ureteric obstruction may occur. Monitor patients for signs and symptoms of ureteric obstruction. Transient or long-term ureteral stents or alternative procedures may be required.

Withhold or permanently discontinue JELMYTO based on the severity of the ureteric obstruction. ( 5.1 ) Bone Marrow Suppression: Thrombocytopenia and neutropenia may occur. Monitor blood counts.

Withhold or permanently discontinue JELMYTO based on the severity. ( 5.2 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus and to use effective contraception.

( 5.3 , 8.1 , 8.3 )

5.1Ureteric Obstruction Ureteric obstruction, including ureteral stenosis and hydronephrosis, occurred in patients receiving JELMYTO. In the Olympus study, ureteric obstruction was reported in 58% (n=41) of patients receiving JELMYTO, including 17% (n=12) of patients who experienced Grade 3 obstruction. The median time to first onset was 72 days (range: 15-462).

Interventions in the 41 patients experiencing ureteric obstruction included ureteral stent placement (88%), balloon dilatation (29%), and nephroureterectomy (4.9%). In the 36 patients who required ureteral stent placement, the median duration of indwelling stents was 52 days (range: 1-292). Ureteric obstruction did not resolve or resolved with sequelae in 44% (n=18) of these patients.

Of the 41 patients who experienced ureteric obstruction, 17% (n=7) experienced Grades 1-2 increase in serum creatinine. In the 42 patients who only received JELMYTO during the treatment phase (no maintenance therapy), ureteric obstruction was reported in 40% (n=17). 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.

5.2Bone Marrow Suppression The use of JELMYTO can result in bone marrow suppression, particularly thrombocytopenia and neutropenia. In the Olympus study, Grade 3 thrombocytopenia occurred in three patients, Grade 3 anemia in one patient, and Grade 3 neutropenia in one patient. Gross extravasation of JELMYTO via urinary tract perforation or impaired mucosa was not observed in these patients.

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.

5.3Embryo-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 [see Use in Specific Populations (8.1 , 8.3) and Clinical Pharmacology (12.1) ].

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Ureteric Obstruction [see Warnings and Precautions (5.1) ] Bone Marrow Suppression [see Warnings and Precautions (5.2) ] The most common adverse reactions (≥ 20%) are ureteric obstruction, flank pain, urinary tract infection, hematuria, renal dysfunction, nausea, abdominal pain, fatigue, dysuria, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact UroGen Pharma at 1-855-987-6436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice. The safety of JELMYTO was evaluated in Olympus, an open-label, single-arm study in 71 patients with LG-UTUC [see Clinical Studies (14) ] . For the 71 patients treated with JELMYTO during the treatment period, the median number of instillations was 6 (range: 3-6).

Following initial treatment, 29 patients were treated with up to 11 doses of maintenance instillations, with a median of 6 instillations (range: 1-11). Serious adverse reactions occurred in 39% of patients who received JELMYTO. Serious adverse reactions in > 3% of patients included ureteric obstruction (including ureteric stenosis and hydronephrosis), flank pain, and urosepsis.

Two deaths occurred due to cerebrovascular accident and failure to thrive. JELMYTO was permanently discontinued due to an adverse reaction in 17 (24%) patients, including 11 patients who discontinued during the treatment phase and 6 who discontinued during the maintenance phase. Adverse reactions resulting in study drug discontinuation of JELMYTO in > 3% of patients who received JELMYTO included ureteric obstruction.

Dosage interruptions due to an adverse reaction occurred in 37% of patients who received JELMYTO. Adverse reactions requiring dosage interruption in > 3% of patients who received JELMYTO included renal dysfunction, ureteric obstruction, urinary tract infection, and flank pain. The most common adverse reactions (≥ 20%) reported were ureteric obstruction, flank pain, urinary tract infection, hematuria, renal dysfunction, nausea, abdominal pain, fatigue, dysuria, and vomiting.

Table 1 summarizes the adverse reactions in Olympus. Table 1: Adverse Reactions (≥ 10% All Grades) in Patients Who Received JELMYTO in Olympus JELMYTO Graded per National Cancer Institute Common Terminology Criteria for Adverse Events. Version 5.0 (NCI CTCAE v5) (n=71) Adverse Reaction All Grades (%) Grade 3-4 (%) Renal and urinary disorders Ureteric Obstruction Includes hydronephrosis, obstructive uropathy, pelvi-ureteric obstruction, ureteric obstruction, ureteric stenosis, and urinary tract obstruction.

58 17 Ureteric stenosis 44 9 Hydronephrosis 18 6 Urinary tract obstruction 7

1.4 Pelvi-ureteric obstruction 6

1.4Ureteric obstruction 2.8

1.4Obstructive uropathy 1.4 0 Flank pain Includes flank pain and back pain. 41

2.8Hematuria Includes hematuria and hemorrhage urinary tract. 34

2.8Urinary tract infection Includes urinary tract infection, pyelonephritis, and urinary tract infection fungal. 34

4.2Renal dysfunction Includes renal impairment, acute kidney injury, and renal failure. 25

2.8 Dysuria 23 0 Pollakiuria 14 0 Gastrointestinal disorders Nausea 25

1.4Abdominal pain Includes abdominal pain and abdominal pain lower. 24

1.4 Vomiting 20

4.2General disorders and administration site conditions Fatigue Includes asthenia, fatigue, and malaise. 24

1.4 Pyrexia 13

1.4 Chills 11 0 Blood and lymphatic system disorders Anemia 14

1.4Skin and subcutaneous tissue disorders Rash Includes rash, dermatitis allergic, rash generalized, genital rash, eczema, rash maculo-papular, and skin exfoliation. 14 0 Pruritus 13 0 Metabolism and nutrition disorders Decr… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed. ( 8.2 )

8.1Pregnancy Risk Summary Based on findings in animals and mechanism of action, JELMYTO can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on JELMYTO use in pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of mitomycin resulted in teratogenicity (see Data ) .

Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% - 4% and 15% - 20%, respectively.

Data Animal Data Teratological changes have been noted with mitomycin in animal studies.

8.2Lactation Risk Summary There are no data on the presence of mitomycin in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with JELMYTO and for 1 week following the last dose.

8.3Females and Males of Reproductive Potential JELMYTO can cause fetal harm when administered to pregnant women [see Use in Specific Populations (8.1) ] . Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating JELMYTO. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with JELMYTO and for 6 months following the last dose.

Males 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.

8.4Pediatric Use Safety and efficacy in pediatric patients have not been established.

8.5Geriatric Use Of the total number of patients in the Olympus trial, 75% (53 patients) were 65 years of age and over and 37% (26 patients) were 75 years of age and over. Clinical studies of JELMYTO did not include sufficient numbers of younger patients less than 65 years old to determine whether they respond differently from older patients.

8.6Renal Impairment No data are available in patients with severe renal impairment. Avoid use of JELMYTO in patients with a Glomerular Filtration Rate of < 30 mL/min.

🤰 Pregnancy 127 words ▾

8.1Pregnancy Risk Summary Based on findings in animals and mechanism of action, JELMYTO can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on JELMYTO use in pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of mitomycin resulted in teratogenicity (see Data ) .

Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% - 4% and 15% - 20%, respectively.

Data Animal Data Teratological changes have been noted with mitomycin in animal studies.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and efficacy in pediatric patients have not been established.

🧓 Geriatric Use 60 words ▾

8.5Geriatric Use Of the total number of patients in the Olympus trial, 75% (53 patients) were 65 years of age and over and 37% (26 patients) were 75 years of age and over. Clinical studies of JELMYTO did not include sufficient numbers of younger patients less than 65 years old to determine whether they respond differently from older patients.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Mitomycin inhibits the synthesis of deoxyribonucleic acid (DNA). The guanine and cytosine content correlates with the degree of mitomycin-induced cross-linking. At high concentrations of the drug, cellular RNA and protein synthesis are also suppressed.

12.2Pharmacodynamics There is insufficient data to characterize an exposure-response relationship or time course of pharmacodynamic response for mitomycin.

12.3Pharmacokinetics Absorption The systemic exposure of mitomycin following instillation of up to 60 mg of mitomycin as JELMYTO into the pyelocalyceal system was evaluated pre-instillation and hourly for up to six hours post-instillation in six patients. The concentrations of mitomycin in plasma were variable and ranged from 2.43 to 12.80 ng/mL over the course of treatment; the mean C max was 6.24 ng/mL, which is estimated to be less than 1% of the expected C max after intravenous administration. Elimination Following instillation into the pyelocalyceal system, JELMYTO forms a semisolid gel which dissolves from normal kidney urine flow releasing mitomycin for up to 4 to 6 hours.

Mitomycin is eliminated unchanged in the urine. Systemically absorbed mitomycin is rapidly cleared from the serum and approximately 10% is excreted unchanged in the urine. Metabolism Mitomycin is metabolized primarily in the liver, but metabolism occurs in other tissues as well.

It is believed that the rate of clearance is inversely proportional to the maximal serum concentration because of saturation of the degradative pathways.

🧬 Mechanism of Action 38 words ▾

12.1Mechanism of Action Mitomycin inhibits the synthesis of deoxyribonucleic acid (DNA). The guanine and cytosine content correlates with the degree of mitomycin-induced cross-linking. At high concentrations of the drug, cellular RNA and protein synthesis are also suppressed.

📦 How Supplied / Storage and Handling 141 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied JELMYTO kit – NDC 72493-103-03 JELMYTO is available in a kit containing the following: Two 40 mg (each) single-dose vials of mitomycin for pyelocalyceal solution supplied as a sterile, lyophilized, grey to greyish-purple, cake or powder. (NDC 72493-101-40) One 20 mL single-dose vial of sterile hydrogel supplied as a sterile, clear, colorless gel with or without bubbles at room temperature or clear, colorless liquid at 2°C to 8°C (36°F to 46°F), to be used as a vehicle for reconstitution. (NDC 72493-102-20)

16.2Storage and Handling Store the JELMYTO kit at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Avoid excessive heat over 40°C (104°F). Protect from light. JELMYTO is a hazardous drug. Follow applicable special handling and disposal procedures . 1

📦 Storage and Handling 52 words ▾

16.2Storage and Handling Store the JELMYTO kit at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Avoid excessive heat over 40°C (104°F). Protect from light. JELMYTO is a hazardous drug. Follow applicable special handling and disposal procedures . 1

📋 Description ~1 min read ▾

11 DESCRIPTION Mitomycin (also known as mitomycin-C) is an alkylating drug isolated from the broth of Streptomyces . Mitomycin is a blue-violet crystalline powder with a molecular formula of C 15 H 18 N 4 O 5 , and a molecular weight of 334.33. Its chemical name is 7-amino-9α-methoxymitosane, and it has the following structural formula: Mitomycin is heat stable, has a high melting point, and is freely soluble in organic solvents.

JELMYTO is supplied in a kit containing two vials of sterile lyophilized mitomycin for pyelocalyceal solution, 40 mg each, and one vial of 20 mL of sterile hydrogel, to be used as a vehicle for reconstitution. Mitomycin for pyelocalyceal solution is a sterile, lyophilized, grey to greyish-purple, cake or powder that contains mitomycin 40 mg and mannitol 80 mg in each vial. Sterile hydrogel is a sterile, clear, colorless gel with or without bubbles at room temperature or clear, colorless liquid at 2°C to 8°C (36°F to 46°F), which contains 0.04 g hydroxypropyl methylcellulose, 5.67 g poloxamer, 0.21 g polyethylene glycol, and water for injection in each vial.

Once reconstituted, JELMYTO is a clear, purple, viscous liquid at 2°C to 8°C (36°F to 46°F) or semisolid gel at room temperature with a concentration of 4 mg per mL of mitomycin, which may contain a few visible particles and have a pH between 6.0 and 8.0. Chemical Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Ureteric Obstruction Inform patients that ureteric obstruction may occur, and ureteral stents or alternative procedures may be required during treatment with JELMYTO. Advise patients to contact their healthcare provider immediately if signs and symptoms of ureteric obstruction, including flank pain and/or fever, occur [see Warnings and Precautions (5.1) ].

Bone Marrow Suppression Inform patients that JELMYTO may decrease blood counts such as white blood cells and platelets. Thus, it is important that periodic assessment of their blood counts be performed to detect the development of neutropenia and thrombocytopenia [see Warnings and Precautions (5.2) ]. Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus.

Advise females to inform their healthcare providers of a known or suspected pregnancy [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1) ] . Advise females of reproductive potential to use effective contraception during treatment with JELMYTO and for 6 months following the last dose [see Use in Specific Populations (8.3) ] . 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 [see Use in Specific Populations (8.3) ].

Lactation Advise women not to breastfeed during treatment with JELMYTO and for 1 week following the last dose [see Use in Specific Populations (8.2) ]. Important Post-Treatment Instructions [see Dosage and Administration (2.1) ] Advise patients that JELMYTO contains mitomycin which is a violet to blue color and may discolor urine following the instillation procedure. Advise patients to avoid contact with urine for at least six hours post-instillation.

Advise patients to void sitting on a toilet, flush the toilet several times after use, and to wash hands, perineum or glans with soap and water after each instillation procedure. Advise patients to wash clothing soiled with urine promptly and separately from other clothing.

🧬 Pharmacokinetics 172 words ▾

12.3Pharmacokinetics Absorption The systemic exposure of mitomycin following instillation of up to 60 mg of mitomycin as JELMYTO into the pyelocalyceal system was evaluated pre-instillation and hourly for up to six hours post-instillation in six patients. The concentrations of mitomycin in plasma were variable and ranged from 2.43 to 12.80 ng/mL over the course of treatment; the mean C max was 6.24 ng/mL, which is estimated to be less than 1% of the expected C max after intravenous administration. Elimination Following instillation into the pyelocalyceal system, JELMYTO forms a semisolid gel which dissolves from normal kidney urine flow releasing mitomycin for up to 4 to 6 hours.

Mitomycin is eliminated unchanged in the urine. Systemically absorbed mitomycin is rapidly cleared from the serum and approximately 10% is excreted unchanged in the urine. Metabolism Mitomycin is metabolized primarily in the liver, but metabolism occurs in other tissues as well.

It is believed that the rate of clearance is inversely proportional to the maximal serum concentration because of saturation of the degradative pathways.

🧬 Pharmacodynamics 19 words ▾

12.2Pharmacodynamics There is insufficient data to characterize an exposure-response relationship or time course of pharmacodynamic response for mitomycin.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The efficacy of JELMYTO is based on the results of the Olympus study (NCT02793128), an open-label, single-arm, multicenter trial that enrolled 71 patients with treatment-naïve or recurrent non-invasive low-grade upper tract urothelial cancer (LG-UTUC) with at least one measurable papillary tumor 5 to ≤ 15 mm located above the ureteropelvic junction; patients who had larger tumors could have had tumor debulking prior to treatment, in order to meet the criteria. Patients were excluded from the trial for a history of carcinoma in situ (CIS) in the urinary tract, invasive urothelial carcinoma within 5 years, high grade papillary urothelial carcinoma within 2 years; or for BCG treatment within 6 months of JELMYTO treatment.

Following biopsy and prior to treatment, patients were required to have at least one remaining visible tumor with a diameter of at least 5 mm. Patients received JELMYTO 4 mg per mL via ureteral catheter or nephrostomy tube with total instillation volume based on individualized volumetric measurements using pyelography with the intent to fill the renal pelvis. Patients were treated with 6 instillations once a week.

Patients who maintained a complete response (CR) after the initial treatment period were allowed to proceed to the follow-up period. During the initial treatment period, 71 patients were treated with JELMYTO, of whom 41 were subsequently continued in the follow-up period. During the follow-up period, 29 patients received at least one dose of maintenance therapy.

The baseline demographic and disease characteristics for the trial population were: median age 71 years (range: 42-87 years); 68% male; 87% White; 90% Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1 and 10% ECOG PS 2. The median number of papillary lesions subsequent to debulking and/or biopsy and prior to treatment was 1 lesion (range: 1, 5), the median diameter of the largest lesion was 8.0 mm (range: 5.0, 15.0), and the median total visible tumor burden was 10.0 mm (range: 5.0, 25.0). Twenty-six (37%) patients underwent tumor debulking during the six weeks preceding enrollment.

Of 71 enrolled patients, 48% had tumors located in regions not amenable to endoscopic resection. General anesthesia was used in 37% of patients for at least one instillation during the treatment period and for 83% of patients for at least one instillation during the follow-up period. The major efficacy outcome measures were CR and durability of CR at 12 months after determination of CR based on ureteroscopic and local pathology assessment.

CR was defined as complete absence of tumor lesions in the ipsilateral pyelocalyceal system at 3 months after initiation of JELMYTO by urine cytology and ureteroscopy. Biopsy was performed if warranted. Durability of response in patients with a CR was evaluated at 3, 6, 9 and 12 months following the initial assessment.

Assessment of durability of CR subsequent to these evaluations was performed per local standards of care. Forty-one patients (58%) achieved CR in the study (95% CI: 45%, 69%). Of the 41 patients who achieved CR, 23 (56%) of the patients remained at CR at the 12-month time point for assessment of durability, 8 (20%) experienced recurrence of disease, and 10 (24%) were unable to be evaluated (died, discontinued from the study, or were indeterminate for ongoing response).

The median duration of response was not reached (range: 0, 18.8 months and ongoing). One patient, who achieved 6 months of durable CR, was diagnosed with metastatic urothelial carcinoma approximately 4.5 months after the last dose of study medication and died from the disease.

🧪 Nonclinical Toxicology 86 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Adequate long-term studies in animals to evaluate carcinogenic potential from instillation of mitomycin into the pyelocalyceal system have not been conducted. Mitomycin has been found to be carcinogenic in rats and mice. At doses approximating the recommended intravenous clinical dose in humans, mitomycin produced a greater than 100% increase in tumor incidence in male Sprague-Dawley rats, and a greater than 50% increase in tumor incidence in female Swiss mice.

The effect of JELMYTO on fertility is unknown.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 83 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Adequate long-term studies in animals to evaluate carcinogenic potential from instillation of mitomycin into the pyelocalyceal system have not been conducted. Mitomycin has been found to be carcinogenic in rats and mice. At doses approximating the recommended intravenous clinical dose in humans, mitomycin produced a greater than 100% increase in tumor incidence in male Sprague-Dawley rats, and a greater than 50% increase in tumor incidence in female Swiss mice.

The effect of JELMYTO on fertility is unknown.

📚 References 8 words ▾

15 REFERENCES 1. "OSHA Hazardous Drugs." OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

📄 Patient Package Insert ~3 min read ▾

Patient Information JELMYTO ® (jel-MYE-toe) (mitomycin) for pyelocalyceal solution This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 09/2022 What is JELMYTO?

JELMYTO is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC). It is not known if JELMYTO is safe and effective for use in children. Who should not receive JELMYTO?

Do not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract. Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you: are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby.

You should not become pregnant during treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO. Females who are able to become pregnant: Your healthcare provider will check to see if you are pregnant before starting treatment with JELMYTO.

You should use effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose. Talk to your healthcare provider if you have questions about birth control options that are right for you. Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose. are breastfeeding or plan to breastfeed.

It is not known if JELMYTO passes into your breast milk. Do not breastfeed during treatment with JELMYTO and for 1 week after the last dose. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine. Especially tell your healthcare provider if you take water pills (diuretic).

How will I receive JELMYTO? Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO treatment. Your healthcare provider will provide instructions about how and when to take sodium bicarbonate.

JELMYTO will be given to you by your healthcare provider. You will receive JELMYTO 1 time a week for 6 weeks. It is important that you receive all 6 doses of JELMYTO according to your healthcare provider's instructions.

Your healthcare provider may recommend up to an additional 11 monthly doses. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. JELMYTO is given to your kidney through a tube called a catheter.

During treatment with JELMYTO, your healthcare provider may tell you to take additional medicines or change how you take your current medicines. Ask your healthcare provider if you have any questions. After receiving JELMYTO: JELMYTO may cause your urine color to change to a violet to blue color.

Avoid contact between your skin and urine for at least 6 hours. To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.

Clothing that comes in contact with urine should be washed right away and washed separately from other clothing. What are the possible side effects of JELMYTO? JELMYTO may cause serious side effects, including: Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction).

If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain. Tell your healthcare provider right away if you develop side pain or feve… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR PHARMACY (IFP) JELMYTO ® (jel-MYE-toe) (mitomycin) for pyelocalyceal solution Purpose of this Instructions for Pharmacy This Instructions for Pharmacy contains information on how to prepare JELMYTO using pharmacy supplies and a Chilling Block. Intended Use of JELMYTO JELMYTO (mitomycin) for pyelocalyceal solution is indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC). 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 20°C to 25°C (68°F to 77°F) for up to 96 hours (4 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: JELMYTO Kit containing: 2 Vials of Mitomycin for Pyelocalyceal Solution, 40 mg/vial 1 Vial Sterile Hydrogel, 20 mL/vial 1 JELMYTO Admixture Label JELMYTO Full Prescribing Information (PI) JELMYTO Instructions for Pharmacy (IFP) JELMYTO Instructions for Administration (IFA) Pharmacy Supplies (Provided by Your Facility) Do not substitute any of these components . 3 × TEVADAPTOR ® or OnGuard ® 2 CSTD Vial Adaptors 3 × TEVADAPTOR ® or OnGuard ® 2 CSTD Syringe Adaptors 1 × Luer Lock connector 2 × 10 mL Luer Lock syringes 1 × 20 mL Luer Lock syringe 1 × 20-25G needle (for drawing up sterile water) 2 mL sterile water 70% Isopropyl alcohol or equivalent 1 × Light protective bag 1 × Chilling Block (device design may vary) Note: The day before your preparation, put the Chilling Block in the freezer at -20°C to -12°C (-4°F to 10.4°F) overnight.

Please refer to the Chilling Block Instructions for Use for more information. Steps to Prepare JELMYTO Admixture A. Freeze Chilling Block The day before preparation, put the Chilling Block in the freezer at -20°C to -12°C (-4°F to 10.4°F) overnight.

Note: Please refer to the Chilling Block Instructions for Use for additional information. 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 adaptor to one of the 10 mL syringes. Connect a syringe adaptor to the 20 mL syringe.

Place the three vials, the 10 mL syringe, and the 20 mL syringe into the Chilling Block for at least 10 minutes. While the vials and syringes are in the Chilling Block, withdraw 2 mL of sterile water into the other 10 mL syringe and set aside for later use. C.

Create Pre-Wetting Solution (PWS) Slowly fill the chilled 20 mL syringe with 14 mL of sterile hydrogel. Recap the chilled 20 mL syringe and place it in the Chilling Block. Slowly fill the chilled 10 mL syringe with 4 mL of sterile hydrogel.

Discard the unused portion of sterile hydrogel. Replace the needle on 2 mL sterile water syringe with the Luer Lock connector. Remove the syringe adaptor from the 4 mL sterile hydrogel syringe.

Connect the 4 mL sterile hydrogel syringe to the other side of the Luer Lock connector on the 2 mL sterile water syringe. Gently mix the sterile water with the sterile hydrogel by pushing the plungers back and forth at least 25 times to create the "pre-wetting solution" (PWS). Transfer the 6 mL PWS into one of the syringes.

Replace the Luer Lock connector on the 6 mL PWS syringe with a new syringe adaptor. Place the 6 mL PWS syringe… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel ~2 min read ▾

PRINCIPAL DISPLAY PANEL - Kit Carton NDC 72493-103-03 Jelmyto ® (mitomycin) for pyelocalyceal solution Attention Pharmacist: Reconstitution is required prior to dispensing. See the Instructions for Pharmacy before proceeding. SINGLE-DOSE KIT Warning: For Pyelocalyceal Use Only Rx Only Contents of Kit: 2 Vials of JELMYTO ® (mitomycin) for pyelocalyceal solution, 40 mg per Vial 1 Vial Sterile Hydrogel, 20 mL per Vial 1 Admixture Label Full Prescribing Information Instructions for Pharmacy Instructions for Administration Warning: Hazardous Drug Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).

Avoid excessive heat over 40°C (104°F). Protect from light. Reconstituted JELMYTO should be instilled as soon as possible after reconstitution.

Store reconstituted JELMYTO at 20°C to 25°C (68°F to 77°F) for up to 96 hours (4 days). Protect reconstituted JELMYTO from light. When ready to instill, chill JELMYTO to -3°C to 5°C (27°F to 41°F) for at least 10 minutes, but no longer than one hour, to revert it to a liquid form.

UroGen ® Pharma PRINCIPAL DISPLAY PANEL - Kit Carton

PRINCIPAL DISPLAY PANEL - 40 mg Vial Label NDC 72493-101-40 Single-Dose Vial Sterile Jelmyto ® (mitomycin) for pyelocalyceal solution 40 mg per Vial See Instructions for Pharmacy for preparation instructions Must be Reconstituted with Sterile Hydrogel Before Use Warning: For Pyelocalyceal Use Only Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Avoid excessive heat over 40°C (104°F). Protect from light.

Warning: Hazardous Drug Rx Only PRINCIPAL DISPLAY PANEL - 40 mg Vial Label

PRINCIPAL DISPLAY PANEL - 20 mL Vial Label NDC 72493-102-20 Single-Dose Vial Sterile Hydrogel For use in preparation of JELMYTO™ (mitomycin) for pyelocalyceal solution Not for Direct Administration See Instructions for Pharmacy for preparation instructions Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Avoid excessive heat over 40°C (104°F). Rx Only 20 mL per Vial PRINCIPAL DISPLAY PANEL - 20 mL Vial Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Mitomycin (matched by generic name) — the program that covers self-administered drugs. 3 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Mitomycin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$74.8K
Claims incl. refills
56
Beneficiaries
39
Spend / beneficiary
$1,916.80
Spend / claim
$1,334.92
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by UroGen Pharma, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
UroGen Pharma, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J9281 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 72490-0046-10 · Nufabrx 72493-0106-03 · UroGen →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.