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Inlexzo

gemcitabine intravesical
Antimetabolite (Intravesical)FDA Approved 2025TAR Therapeutics
Route
Oral
Half-Life
~22 hrs
FDA Approved
2025
Manufacturer
TAR Therapeutics
1. Indications and Usage

Adults with BCG-unresponsive NMIBC with carcinoma in situ, with or without papillary tumors.

2. Dosage and Administration

225 mg intravesical delivery system every 3 weeks for 6 months, then every 12 weeks for up to 18 months.

3. Dosage Forms and Strengths

Intravesical system: 225 mg co-packaged with urinary catheter

4. Contraindications

Active UTI. Bladder perforation.

5. Warnings and Precautions
  • Urinary Tract Adverse Reactions: Dysuria, hematuria common.
  • Device-Related Complications: Potential catheter-related injury.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Dysuria (48%), Hematuria (42%), Urinary Frequency (36%), UTI (24%), Pelvic Pain (18%), Fatigue (16%)

Dysuria
48%
Hematuria
42%
Urinary Frequency
36%
UTI
24%
Pelvic Pain
18%
Fatigue
16%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

No formal drug interaction studies. Systemic exposure minimal.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Gemcitabine inhibits DNA synthesis. The intravesical delivery system provides sustained, continuous local exposure maintaining therapeutic concentrations longer than standard bolus instillation.

Pharmacokinetics

Sustained intravesical release ~24 hours. Systemic exposure substantially lower than IV.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
  • SunRISe-1 — Gemcitabine intravesical in BCG-unresponsive NMIBC with CIS. Phase III, n=83.
    🔬 NCT04640623 ↗
Additional Resources
📋 All Gemcitabine Intravesical Trials on ClinicalTrials.gov ↗ 📚 PubMed: Gemcitabine Intravesical Clinical Trials ↗
FDA-Approved Tumor Types

Inlexzo has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Bladder Cancer
External Resources
📋 DailyMed Label ↗🏛️ FDA Drugs@FDA ↗🔬 ClinicalTrials.gov ↗📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Inlexzo. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Inlexzo (gemcitabine intravesical) approved for?

Inlexzo (gemcitabine intravesical) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Inlexzo (gemcitabine intravesical) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Inlexzo (gemcitabine intravesical) work?

Gemcitabine inhibits DNA synthesis. The intravesical delivery system provides sustained, continuous local exposure maintaining therapeutic concentrations longer than standard bolus instillation.

What are the most common side effects?

Dysuria (48%), Hematuria (42%), Urinary Frequency (36%), UTI (24%), Pelvic Pain (18%), Fatigue (16%) Dysuria 48% Hematuria 42% Urinary Frequency 36% UTI 24% Pelvic Pain 18% Fatigue 16%

← All TherapiesFull Prescribing Information ↗