INLEXZO gemcitabine intravesical 225 mg System, 1 system
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Nucleoside Metabolic Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- 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...
Patient education
Supplement & herbal interactions
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 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 system | Per each | Per 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. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Inlexzo 225 mgthis 57894-0225-99 | Janssen | 1 system | — | — | FDA listed | — |
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⏳ Availability & generic status
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.
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.
🛈 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.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| 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 |
| Code | What it grants | Expires |
|---|---|---|
| NP | New Product | Sep 9, 2028 |
Is there a generic version of INLEXZO 225MG INTRAVESICAL SYS?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
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Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 57894-0225-01 | 1 SYSTEM in 1 BOX (57894-225-01) | 2025-09-14 | Active |
| 57894-0225-99 You're viewing this | 1 SYSTEM in 1 BOX (57894-225-99) | 2025-09-14 | Active |
Pack size FAQ
What quantity is in NDC 57894-0225-99?
What is the difference between NDC 57894-0225-99 and NDC 57894-0225-01?
What NDC number is used to bill for this package of INLEXZO gemcitabine intravesical 225 mg System?
🧭 About this NDC listing & data coverage
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) | — 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 | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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 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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
8.4Pediatric Use Safety and effectiveness of INLEXZO in pediatric patients have not been established.
🧓 Geriatric Use ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
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) ].