INLEXZO 225 mg/1
gemcitabine intravesical · SYSTEM · Janssen Biotech, Inc
INLEXZO is a system containing gemcitabine intravesical at 225 mg/1, taken intravesical. Manufactured by Janssen Biotech, Inc.
Key Facts
- Brand Name
- INLEXZO
- Generic Name
- gemcitabine intravesical
- NDC Code (Product)
57894-225- Manufacturer
- Janssen Biotech, Inc
- Strength
- 225 mg/1
- Dosage Form
- SYSTEM
- Route
- INTRAVESICAL
- Marketing Status
- Application #
- NDA219683
- Drug Class
- Nucleoside Metabolic Inhibitor [EPC]
- Marketing Start
- 09/14/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & 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 & 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 ) 2.1 Important 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. 2.2 Recommended Dosage Insert INLEXZO (225 mg of gemcitabine)…
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 )
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. 6.1 Clinical 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 1…
Frequently Asked Questions
What is INLEXZO used for?
INLEXZO contains gemcitabine intravesical. It is a system taken intravesical. Consult your doctor for specific uses.
Is INLEXZO a controlled substance?
INLEXZO is not classified as a controlled substance by the DEA.
What is the generic name for INLEXZO?
The generic name for INLEXZO is gemcitabine intravesical. There are no other listed brand versions of gemcitabine intravesical.
What is the NDC code for INLEXZO 225 mg/1?
The NDC (National Drug Code) for INLEXZO 225 mg/1 is 57894-225, listed by Janssen Biotech, Inc.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)