Initial US Approval:

2025

Key Clinical Studies:

SunRISe-1 (NCT04640623)

Drug Class/Description:

Nucleoside metabolic inhibitor-containing intravesical system

Indications and Usage:

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. 

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).
• Insert into the bladder using the co-packaged urinary catheter and stylet only.
• Remove INLEXZO after each 3-week indwelling period. 
• See Full Prescribing Information and Instructions for Use for insertion and removal procedures.

Dosage Forms and Strengths: 

• One single-dose 225 mg gemcitabine intravesical system

Contraindications: 

• Perforation of the bladder
• Prior hypersensitivity reaction to gemcitabine or any component of the product 

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.
• Risk of Metastatic Bladder Cancer with Delayed Cystectomy: Delaying cystectomy can lead to the development of metastatic bladder cancer, which can be lethal.
• Magnetic Resonance Imaging (MRI) Safety: INLEXZO can only be safely scanned with MRI under certain conditions.
• Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. 

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. 

Use in Specific Populations:

• Lactation: Advise not to breastfeed.

Adapted From:

https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219683s000lbl.pdf

 

Every health-care provider should make their own determination regarding specific safe and appropriate patient care practices, including drug dosages and indications. The provider should always consult the most recent prescribing/product information. FDA Focus information is not guaranteed to be accurate, complete, or current. JADPRO and its editors, authors, reviewers, and commentators cannot be held responsible for any liability incurred as a consequence of the application of any of the information listed within.