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INLEXZO gemcitabine intravesical 225 mg System, 1 system — NDC 57894-0225-01 package photo

INLEXZO gemcitabine intravesical 225 mg System, 1 system

by Janssen Biotech, Inc · 1 SYSTEM in 1 BOX (57894-225-01)
NDC 57894-0225-01
🏷️ FDA NDC (as labeled) 57894-225-01 billing pads the product segment with a zero
This package
Contains1 system Pack sizes2 compare ↓
Also comes in: 1 system 57894-0225-99
Rx only Brand On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 57894-225-01
Product NDC 57894-225
11-digit billing NDC 57894022501
NCPDP billing unit EA — each (per item)
RxCUI 2723386, 2723391
UNII B76N6SBZ8R
Application # NDA219683
SPL Set ID 3aef8dbc-34d0-4150-89f0-3b16cf0fbfdb
Established class (EPC) Nucleoside Metabolic Inhibitor
Mechanism of action Nucleic Acid Synthesis Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-09-14
Route INTRAVESICAL
Dosage form SYSTEM
Substance GEMCITABINE
GPI-14 21300034102320
GCN Seq No 088228
GCN 58328
HICL code 010798
Ingredient (HICL) Gemcitabine Hcl
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1B
Therapeutic class — specific (HIC3) Antineoplastic - Antimetabolites
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name INLEXZO 225MG INTRAVESICAL SYS
FDB brand name Inlexzo
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 57894-225-01 — 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 → 57894-0225-01. 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 Nucleoside Metabolic Inhibitor class.

Pharmacologic class Nucleoside Metabolic Inhibitor
Drug family (ATC) Pyrimidine analogues
How it works Nucleic Acid Synthesis Inhibitors
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.

🏭 Manufacturer & labeler

LabelerJanssen Biotech, Inc
Application holderJANSSEN BIOTECH INC
FDA applicationNDA219683 (NDA)
Labeler code57894
First marketedSep 2025
Product typeHuman Prescription Drug
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.

🩺 Clinical

Label name INLEXZO 225MG INTRAVESICAL SYS Ingredient Gemcitabine Hcl
📖 What it is MedlinePlus · NLM

Gemcitabine intravesical system is used to treat a certain type of bladder cancer. Gemcitabine is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Gemcitabine is used for several different cancers depending on which form you receive. The IV injection (brands include Avgemsi and Gemcitabine) treats pancreatic cancer, non-small...
  • Common side effects include nausea, vomiting, fatigue from low red blood cells, fever, and skin rash. Your care team will regularly check your blood counts because gemcitabine can...
  • What side effects should I expect, and which ones mean I need to call my doctor right away?
  • No — gemcitabine can seriously harm or kill an unborn baby, so it must not be used during pregnancy. If you are a woman of childbearing age, you'll need to use reliable contracepti...
📖 Read our full Gemcitabine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • 8 mg UNII Q662QK8M3B
    Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
  • UNII 2126FD486L
    Polyethylene oxide 600000 is a synthetic polymer derived from ethylene. It acts as a binder and thickener in medicines, helping hold ingredients together and control how quickly the drug dissolves or releases.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • UNII 8W8T17847W
    A nitrogen-containing chemical compound used in pharmaceuticals as a humectant to retain moisture, and sometimes as a keratolytic agent in topical formulations to help soften and remove dead skin cells.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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.

💲 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 · J9183 $72,984.241 / J9183 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)57894-225-01
11-digit billing NDC57894-0225-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ9183
DescriptorGEMCITABINE INTRAVESICAL SYSTEM, 225 MG
Billing units / pkg1 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Inlexzo 225 mgthis 57894-0225-01 Janssen 1 system — — 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

🏛️
2025
First FDA approval
Sep 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2038
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 Nov 2038. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Sep 9, 2025 RLD RS ⏳ ~12.2 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 12636300 — method of use (U-4552)
US 8679094 — drug product
US 10729823 — drug product
US 12403086 — drug product
US 12576253 — drug product
US 12447241 — drug product
Exclusivity NP
2025 2027 2029 2031 2033 2035 2037 2039
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 (6)
PatentTypeUse codeExpires
US 12636300 ↗ Method of use U-4552 Nov 7, 2038
US 8679094 ↗ Drug product — Apr 15, 2032
US 10729823 ↗ Drug product — Aug 19, 2034
US 12403086 ↗ Drug product — Jun 28, 2030
US 12576253 ↗ Drug product — Dec 17, 2030
US 12447241 ↗ Drug product — Aug 19, 2034
FDA exclusivity
CodeWhat it grantsExpires
NPNew ProductSep 9, 2028
Common questions
Is there a generic version of INLEXZO 225MG INTRAVESICAL SYS?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for INLEXZO 225MG INTRAVESICAL SYS. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Nov 2038 — 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.

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

Medicare Part D (outpatient prescription) spending for Inlexzo — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Inlexzo. 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
$11.8M
Claims incl. refills
163
Beneficiaries
73
Spend / beneficiary
$161,648.91
Spend / claim
$72,394.91
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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Gemcitabine intravesical — the ingredient across all brands.

Top reported reactions

Dysuria54
Pollakiuria51
Micturition Urgency28
Urinary Tract Infection21
Bladder Pain18
Bladder Spasm18
Haematuria18

Age at onset

Adult4
Elderly54

Reporter sex

0 reports
Male · 84%
Female · 16%

Serious outcomes

Hospitalization21
Death2
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2025 2026 236 26
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
57894-0225-01 You're viewing this 1 SYSTEM in 1 BOX (57894-225-01) 2025-09-14 Active
57894-0225-99 1 SYSTEM in 1 BOX (57894-225-99) 2025-09-14 Active

Pack size FAQ

What quantity is in NDC 57894-0225-01?
NDC 57894-0225-01 contains 1 system — 1 system in 1 box.
What is the difference between NDC 57894-0225-01 and NDC 57894-0225-99?
Both are INLEXZO gemcitabine intravesical 225 mg System — the drug itself is identical. NDC 57894-0225-01 is the 1 system package, while NDC 57894-0225-99 is the 1 system package.
What NDC number is used to bill for this package of INLEXZO gemcitabine intravesical 225 mg System?
Bill NDC 57894-0225-01 — the 11-digit billing format is 57894022501. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
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 ✓ Available
Inactive ingredients (structured) ✓ 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 FDA registers it as 57894-225-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 57894-0225-01, written without dashes as 57894022501. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 57894-0225-01, the first segment (57894) is the labeler code FDA assigned to Janssen Biotech, Inc; the middle segment (0225) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Janssen Biotech, Inc. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 system (57894-0225-99). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Janssen Biotech, 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 J9183 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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
🎯 Indications and Usage 69 words ▾

1 INDICATIONS AND USAGE INLEXZO is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. INLEXZO is a nucleoside metabolic inhibitor-containing intravesical system, indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION For Intravesical Administration Only Insert INLEXZO (225 mg of gemcitabine) into the bladder once every 3 weeks up to 6 months (8 doses), followed by once every 12 weeks (6 doses). ( 2.2 ) Insert into the bladder using the co-packaged urinary catheter and stylet only. ( 2.1 ) Remove INLEXZO after each 3-week indwelling period.

( 2.2 ) See Full Prescribing Information and Instructions for Use for insertion and removal procedures. ( 2.3 )

2.1Important Administration Instructions Administer INLEXZO intravesically only. Do NOT administer by any other route. INLEXZO is co-packaged with a urinary catheter and stylet used to insert INLEXZO through the urinary catheter into the bladder.

Administer using the co-packaged urinary catheter and stylet only. INLEXZO should be inserted and removed by a trained healthcare provider. Healthcare providers should become thoroughly familiar with the insertion and removal instructions before attempting insertion or removal of INLEXZO.

Prophylactic antibiotics may be used at the discretion of the treating healthcare provider with each INLEXZO insertion and removal.

2.2Recommended Dosage Insert INLEXZO (225 mg of gemcitabine) into the bladder once every 3 weeks for up to 6 months (8 doses), followed by once every 12 weeks for up to 18 months (6 doses), or until persistent or recurrent NMIBC, disease progression, or unacceptable toxicity. Remove INLEXZO after each 3-week indwelling period. Missed Dose If a dose is missed, it should be administered as closely as possible to the original treatment schedule.

2.3Preparation and Intravesical Administration See the Instructions for Use enclosed in the carton for complete information on preparation, intravesical administration, and removal of INLEXZO. INLEXZO is a hazardous drug. Follow applicable special handling and disposal procedures while handling INLEXZO and during the insertion and removal procedure.

1 Instruct patients to drink approximately 1500 mL of fluids per day during therapy with INLEXZO to ensure adequate urine production for drug release. Instruct patients not to empty the bladder immediately prior to the insertion procedure. Presence of urine in the bladder can facilitate deployment of INLEXZO.

Patients can resume micturition after the insertion procedure. During indwelling period of approximately 3 weeks, advise patients to avoid urine contact with skin, to void urine sitting on a toilet, to wash hands with soap and water and to wash their genital area with water after each urination, and to flush the toilet after use.

💊 Dosage Forms and Strengths 50 words ▾

3 DOSAGE FORMS AND STRENGTHS One single-dose 225 mg strength gemcitabine intravesical system consisting of a flexible bi-oval shaped tube containing an almost white to light pink-brown colored component at the center surrounded by off white to light blue components. One single-dose 225 mg gemcitabine intravesical system ( 3 )

⛔ Contraindications 53 words ▾

4 CONTRAINDICATIONS INLEXZO is contraindicated in patients with: Perforation of the bladder [see Warnings and Precautions (5.1) ] . Prior hypersensitivity reactions to gemcitabine or any component of the product. Perforation of the bladder ( 4 , 5.1 ) Prior hypersensitivity reaction to gemcitabine or any component of the product ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Risks in Patients with Perforated Bladder : Evaluate the bladder before the intravesical insertion of INLEXZO. Do not administer to patients with a perforated bladder or in whom the integrity of the bladder mucosa has been compromised. ( 4 , 5.1 ) Risk of Metastatic Bladder Cancer with Delayed Cystectomy : Delaying cystectomy can lead to the development of metastatic bladder cancer, which can be lethal.

( 5.2 ) Magnetic Resonance Imaging (MRI) Safety : INLEXZO can only be safely scanned with MRI under certain conditions. ( 5.3 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

( 5.4 , 8.1 , 8.3 )

5.1Risks in Patients with Perforated Bladder INLEXZO may lead to systemic exposure to gemcitabine and to severe adverse reactions if administered to patients with a perforated bladder or to those in whom the integrity of the bladder mucosa has been compromised. Evaluate the bladder before the intravesical administration of INLEXZO and do not administer to patients with a perforated bladder or mucosal compromise until bladder integrity has been restored [see Contraindications (4) ].

5.2Risk of Metastatic Bladder Cancer with Delayed Cystectomy Delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal. The risk of developing muscle invasive or metastatic bladder cancer increases the longer cystectomy is delayed in the presence of persisting CIS. Of the 83 evaluable patients with BCG-unresponsive CIS treated with INLEXZO in Cohort 2 of SunRISe-1, seven patients (8%) progressed to muscle invasive (T2 or greater) bladder cancer.

Three patients (3.5%) had progression determined at the time of cystectomy. The median time between determination of persistent or recurrent CIS or T1 and progression to muscle invasive disease was 94 days.

5.3Magnetic Resonance Imaging (MRI) Safety INLEXZO may be used with MRI only under the specific predefined conditions provided below to avoid potential safety hazards or severe adverse reactions. Based on clinical experience in patients treated with INLEXZO indwelling in the bladder who underwent MRI scans and nonclinical testing, INLEXZO is MR Conditional. A patient with INLEXZO indwelling in the bladder can be scanned in an MR system under the following conditions: Static magnetic field of 1.5-Tesla and 3-Tesla, only.

Maximum spatial gradient magnetic field of 5000 Gauss/cm or less. Maximum magnetic resonance system reported, whole body averaged specific absorption rate of 2-W/kg for 60 minutes of continuous scanning (i.e., per pulse sequence or back-to-back sequences without breaks) in the Normal Operating Mode of operation for the MR system. Under the scan conditions defined, INLEXZO is expected to produce a maximum temperature rise of 2°C after 15 minutes of continuous scanning.

In nonclinical testing, the image artifact caused by INLEXZO extends approximately 2 mm from INLEXZO using a gradient echo pulse sequence and a 3-Tesla MR system.

5.4Embryo-Fetal Toxicity Based on animal data and its mechanism of action, INLEXZO can cause fetal harm when administered to a pregnant woman if systemic exposure occurs [see Clinical Pharmacology (12.1) ] . In animal reproduction studies, systemic administration of gemcitabine was teratogenic, embryotoxic, and fetotoxic in mice and rabbits. Advise pregnant women and females of reproductive potential of the potential risk to a fetus.

Advise females of reproductive potential to use effective contraception during treatment and for 6 months after final removal of INLEXZO. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after final removal of INLEXZO [see Use in Specific Populations (8.1 , 8.3) ] .

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most common (>15%) adverse reactions, including laboratory abnormalities, are urinary frequency, urinary tract infection, dysuria, micturition urgency, decreased hemoglobin, increased lipase, urinary tract pain, decreased lymphocytes, hematuria, increased creatinine, increased potassium, increased AST, decreased sodium, bladder irritation, and increased ALT. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-526-7736 (1-800-JANSSEN) 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 the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of INLEXZO monotherapy was evaluated in Cohort 2 of SunRISe-1, a multi-center, open-label study in 85 adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors [see Clinical Studies (14.1) ].

Patients received INLEXZO (225 mg of gemcitabine) inserted into the bladder every 3 weeks for 6 months, followed by once every 12 weeks for up to 18 months, or until unacceptable toxicity, disease persistence, recurrence, or progression [see Dosage and Administration (2.2) ] . The median number of doses of INLEXZO administered to patients was 9 (range: 1 to 14) doses. The median duration of exposure to INLEXZO was 41 weeks (range: 1 to 108 weeks).

Serious adverse reactions occurred in 24% of patients receiving INLEXZO. Serious adverse reactions that occurred in >2% of patients included urinary tract infection, hematuria, pneumonia, and urinary tract pain. Fatal adverse reactions occurred in 1.2% of patients who received INLEXZO, including cognitive disorder.

Permanent discontinuation of INLEXZO due to an adverse reaction occurred in 7% of patients. Adverse reactions which resulted in permanent discontinuation of INLEXZO in >1% of patients included bladder irritation, urinary frequency, cognitive disorder, hydronephrosis, and urinary tract disorder. Dosage interruptions of INLEXZO due to an adverse reaction occurred in 41% of patients.

Adverse reactions which required dosage interruption in >3% of patients included urinary tract infection, urinary tract pain, hematuria, urinary frequency, micturition urgency, dysuria, and genital pain. The most common (>15%) adverse reactions, including laboratory abnormalities, were urinary frequency, urinary tract infection, dysuria, micturition urgency, decreased hemoglobin, increased lipase, urinary tract pain, decreased lymphocytes, hematuria, increased creatinine, increased potassium, increased AST, decreased sodium, bladder irritation, and increased ALT.

Table 1 summarizes the adverse reactions in SunRISe-1. Table 1: Adverse Reactions Occurring in >15% of Patients in SunRISe-1 Adverse Reaction INLEXZO N=85 All Grades % Grade 3 or 4 % Urinary frequency 48 0 Urinary tract infection Includes other related terms 44 6 Dysuria 42 0 Micturition urgency 34 0 Urinary tract pain 26 7 Hematuria 24

2.4Bladder irritation 16 0 Other clinically significant adverse reactions (<15%) included fatigue (14%), genital pain (12%), diarrhea (11%), urinary incontinence (9%), urinary retention (7%), and nocturia (4.7%). Table 2: Select Laboratory Abnormalities (>15%) That Worsened from Baseline in Patients Who Received INLEXZO in SunRISe-1 Laboratory Abnormality INLEXZO The denominator used to calculate the rate varied from 82 to 83 based on the number of patients with a baseline value and at least one post-treatment value.

All Grades (%) Grade 3 or 4 (%) Hematology Decreased Hemoglobin 31

1.2 Decreased Lymphocytes 24

4.8 Chemistry Increased Lipase 28 12 Increased Creatinine 24 0 Increased Potassium 22

1.2 Increased AST 17

1.2 Decreased Sodium 16

4.8Increased ALT 16 1.2

👥 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 animal data and its mechanism of action, INLEXZO can cause fetal harm when administered to a pregnant woman if systemic exposure occurs [see Clinical Pharmacology (12.1) ] . There are no available data on the use of INLEXZO in pregnant women to inform a drug-associated risk. In animal reproduction studies, systemic administration of gemcitabine was teratogenic, embryotoxic, and fetotoxic in mice and rabbits (see Data ) .

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Gemcitabine is embryotoxic in mice.

Daily systemic dosing of gemcitabine to pregnant mice increased the incidence of fetal malformation (cleft palate, incomplete ossification) at doses of 1.5 mg/kg/day. Gemcitabine was embryotoxic and fetotoxic in rabbits. Daily systemic dosing of gemcitabine to pregnant rabbits resulted in fetotoxicity (decreased fetal viability, reduced litter sizes, and developmental delays) and increased the incidence of fetal malformations (fused pulmonary artery, absence of gall bladder) at doses of 0.1 mg/kg/day.

8.2Lactation Risk Summary There is no information regarding the presence of gemcitabine or its metabolites in human milk, or their effects on the breastfed infant or milk production following INLEXZO administration. Because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment and for 1 week after final removal of INLEXZO.

8.3Females and Males of Reproductive Potential INLEXZO can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ]. Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating INLEXZO. Contraception Females Advise females of reproductive potential to use effective contraception during treatment and for 6 months after final removal of INLEXZO.

Males Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after final removal of INLEXZO [see Nonclinical Toxicology (13.1) ] . Infertility Males Based on animal studies, INLEXZO may impair fertility in males of reproductive potential [see Nonclinical Toxicology (13.1) ] . It is not known whether these effects on fertility are reversible.

8.4Pediatric Use Safety and effectiveness of INLEXZO in pediatric patients have not been established.

8.5Geriatric Use Of the patients given INLEXZO monotherapy in Cohort 2 of SunRISe-1, 72% were 65 years of age or older and 34% were 75 years or older. There were insufficient numbers of patients <65 years of age to determine if these patients respond differently to patients 65 years of age and older.

🤰 Pregnancy 193 words ▾

8.1Pregnancy Risk Summary Based on animal data and its mechanism of action, INLEXZO can cause fetal harm when administered to a pregnant woman if systemic exposure occurs [see Clinical Pharmacology (12.1) ] . There are no available data on the use of INLEXZO in pregnant women to inform a drug-associated risk. In animal reproduction studies, systemic administration of gemcitabine was teratogenic, embryotoxic, and fetotoxic in mice and rabbits (see Data ) .

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Gemcitabine is embryotoxic in mice.

Daily systemic dosing of gemcitabine to pregnant mice increased the incidence of fetal malformation (cleft palate, incomplete ossification) at doses of 1.5 mg/kg/day. Gemcitabine was embryotoxic and fetotoxic in rabbits. Daily systemic dosing of gemcitabine to pregnant rabbits resulted in fetotoxicity (decreased fetal viability, reduced litter sizes, and developmental delays) and increased the incidence of fetal malformations (fused pulmonary artery, absence of gall bladder) at doses of 0.1 mg/kg/day.

🧒 Pediatric Use 15 words ▾

8.4Pediatric Use Safety and effectiveness of INLEXZO in pediatric patients have not been established.

🧓 Geriatric Use 54 words ▾

8.5Geriatric Use Of the patients given INLEXZO monotherapy in Cohort 2 of SunRISe-1, 72% were 65 years of age or older and 34% were 75 years or older. There were insufficient numbers of patients <65 years of age to determine if these patients respond differently to patients 65 years of age and older.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Gemcitabine kills cells undergoing DNA synthesis and blocks the progression of cells through the G1/S-phase boundary. Gemcitabine is metabolized by nucleoside kinases to diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides. Gemcitabine diphosphate inhibits ribonucleotide reductase, an enzyme responsible for catalyzing the reactions that generate deoxynucleoside triphosphates for DNA synthesis, resulting in reductions in deoxynucleotide concentrations, including dCTP.

Gemcitabine triphosphate competes with dCTP for incorporation into DNA. The reduction in the intracellular concentration of dCTP by the action of the diphosphate enhances the incorporation of gemcitabine triphosphate into DNA (self-potentiation). After the gemcitabine nucleotide is incorporated into DNA, only one additional nucleotide is added to the growing DNA strands, which eventually results in the initiation of apoptotic cell death.

12.2Pharmacodynamics The exposure-response relationship and time-course of pharmacodynamic response for the safety and effectiveness of INLEXZO have not been fully characterized.

12.3Pharmacokinetics The systemic exposure of gemcitabine and the inactive uracil metabolite (2´-deoxy-2´,2´-difluorouridine [dFdU]), were evaluated between Days 2 and 7 during the indwelling period. The plasma gemcitabine concentrations were below the lower limit of quantification (0.1 µg/mL) in all patients at all time points. Eighteen patients (17%) had at least one quantifiable plasma dFdU concentration above the lower limit of quantification (0.1 µg/mL) and the maximum observed plasma dFdU concentration was 0.4 µg/mL.

Plasma concentrations of both gemcitabine and dFdU are estimated to be less than 1% of the expected C max after intravenous administration of gemcitabine. Excretion Gemcitabine and dFdU are excreted in urine throughout the indwelling period for INLEXZO. Of the total gemcitabine dose, 77% was excreted by Day 7 and 99% was excreted by Day 21 in urine as gemcitabine and dFdU.

Mean urinary excretion on Days 2 through 5 ranged from 21 to 32 mg per day excreted in the urine as gemcitabine and dFdU.

🧬 Mechanism of Action 121 words ▾

12.1Mechanism of Action Gemcitabine kills cells undergoing DNA synthesis and blocks the progression of cells through the G1/S-phase boundary. Gemcitabine is metabolized by nucleoside kinases to diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides. Gemcitabine diphosphate inhibits ribonucleotide reductase, an enzyme responsible for catalyzing the reactions that generate deoxynucleoside triphosphates for DNA synthesis, resulting in reductions in deoxynucleotide concentrations, including dCTP.

Gemcitabine triphosphate competes with dCTP for incorporation into DNA. The reduction in the intracellular concentration of dCTP by the action of the diphosphate enhances the incorporation of gemcitabine triphosphate into DNA (self-potentiation). After the gemcitabine nucleotide is incorporated into DNA, only one additional nucleotide is added to the growing DNA strands, which eventually results in the initiation of apoptotic cell death.

📦 How Supplied / Storage and Handling 121 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied INLEXZO (gemcitabine intravesical system) contains 225 mg gemcitabine. INLEXZO (NDC# 57894-225-01) is available in a carton containing: One sterile single-dose of INLEXZO in two clear laminate sleeves and packaged in an inner pouch. The inner pouch and a desiccant are packaged in an outer foil pouch.

The outside surfaces of the inner and outer pouches are not sterile. One sterile urinary catheter and one sterile stylet packaged together in a pouch. Storage Store in the original carton at 20°C to 25°C (68°F to 77°F); with excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] .

Handling INLEXZO is a hazardous drug. Follow applicable special handling and disposal procedures. 1

📦 Storage and Handling 43 words ▾

Storage Store in the original carton at 20°C to 25°C (68°F to 77°F); with excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . Handling INLEXZO is a hazardous drug. Follow applicable special handling and disposal procedures. 1

📋 Description ~2 min read ▾

11 DESCRIPTION INLEXZO contains gemcitabine hydrochloride, a nucleoside metabolic inhibitor. Gemcitabine hydrochloride is 2'-deoxy-2',2'- difluorocytidine monohydrochloride (β-isomer) with a molecular formula of C9H11F2N3O4 ∙ HCl, and a molecular weight of 299.66. The structural formula is: INLEXZO is a sterile, non-resorbable intravesical system containing the equivalent of 225 mg gemcitabine (present as 256.3 mg of gemcitabine hydrochloride).

Gemcitabine Intravesical System INLEXZO is a bi-oval-shaped tube containing an almost white to light pink-brown colored gemcitabine component at the center surrounded on each side by off white to light blue-colored osmotic components. The gemcitabine component contains 225 mg of gemcitabine and the following inactive ingredients: polyethylene glycol 8000 (8.0 mg), povidone K30 (13.4 mg), and urea (42.6 mg). The osmotic components contain the following inactive ingredients: FD&C Blue No.1 (0.0042 mg), polyethylene oxide 600,000 (72.0 mg), and urea (648.0 mg).

The silicone tube contains two lumens, the larger one containing the drug components and silicone spacers, and the smaller one containing a superelastic nitinol wire in a predefined shape (wireform). Both lumens are capped with a silicone adhesive. The lumen containing the gemcitabine and osmotic components has a single delivery orifice.

INLEXZO's coiled dimensions are approximately 5.5 cm wide × 4.5 cm high. Urinary Catheter and Stylet INLEXZO is co-packaged with a sterile urinary catheter and a sterile stylet, required for transurethral insertion into the bladder. The urinary catheter and stylet are made of thermoplastic elastomer and polyethene, and consist of the following components: A semi-transparent urinary catheter, with a rounded blunt distal tip that includes a coudé tip, a product exit port near the distal tip, and a lumen which extends from the exit port to an open proximal end.

The outer diameter of the urinary catheter is 5.82 mm (17.5 Fr). Printed depth markings are placed on the urinary catheter to indicate insertion depth and orientation of the coudé tip to assist the user during insertion. A green stylet with a hub at the proximal end is used to advance INLEXZO through the urinary catheter lumen and into the bladder.

The stylet length and proximal hub prevent the stylet's distal end from advancement beyond the exit port. Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise patients to read the FDA-approved patient labeling (Patient Information). Risk of Metastatic Bladder Cancer with Delayed Cystectomy Inform patients that delaying cystectomy could lead to development of metastatic bladder cancer. Discuss the risk of metastatic bladder cancer and that the risk increases the longer cystectomy is delayed in the presence of persistent CIS [see Warnings and Precautions (5.2) ] .

Magnetic Resonance Imaging (MRI) Safety Inform patients that INLEXZO can only be safely scanned with MRI under specific conditions [see Warnings and Precautions (5.3) ] . Instruct patients who will have an MRI to tell their healthcare provider that they have INLEXZO. This information is included in the MRI Safety Information Card.

Complete the MRI Safety Information Card and give it to the patient. Embryo-Fetal Toxicity Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.4) and Use in Specific Populations (8.1) ]. Advise females of reproductive potential to use effective contraception during treatment and for 6 months after final removal of INLEXZO [see Use in Specific Populations (8.3) ] .

Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after final removal of INLEXZO [see Use in Specific Populations (8.3) ]. Lactation Advise women not to breastfeed during treatment and for 1 week after final removal of INLEXZO [see Use in Specific Populations (8.2) ]. Infertility Advise males of reproductive potential that INLEXZO may impair fertility [see Use in Specific Populations (8.3) ] .

Important Post-Treatment Instructions Instruct patients not to empty the bladder immediately prior to the insertion procedure. Advise patients to avoid contact with urine while INLEXZO is indwelling in the bladder and for at least 24 hours post-removal [see Clinical Pharmacology (12.3) ] . Advise patients to avoid urine contact with skin by voiding sitting on a toilet, flushing the toilet after use, and to wash hands with soap and water and to wash their genital area with water after each urination.

Advise patients to wash clothing soiled with urine promptly and separately from other clothing [see Dosage and Administration (2.3) ].

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