What are the most common side effects of GEMCITABINE INTRAVESICAL?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for GEMCITABINE INTRAVESICAL. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is GEMCITABINE INTRAVESICAL the same as INLEXZO?

INLEXZO is a brand name for GEMCITABINE INTRAVESICAL. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

GEMCITABINE INTRAVESICAL

Q: What is GEMCITABINE INTRAVESICAL used for?

GEMCITABINE INTRAVESICAL (brand name INLEXZO) is a Chemotherapy indicated for 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.

Q: How does GEMCITABINE INTRAVESICAL work?

GEMCITABINE INTRAVESICAL works through the following mechanism: 12.1 Mechanism 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..

Chemotherapy

Brand names: INLEXZO

Intravesical

Mechanism of Action

12.1 Mechanism 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.

Indications

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 )

Contraindications

• 5.1 ) Prior hypersensitivity reaction to gemcitabine or any component of the product ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Risks in Patients with Perforated Bladder : Evaluate the bladder before the intravesical insertion of INLEXZO
1 ) Risk of Metastatic Bladder Cancer with Delayed Cystectomy : Delaying cystectomy can lead to the development of metastatic bladder cancer, which can be lethal
Advise patients of the potential risk to a fetus and to use effective contraception
1 Risks 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

Known Side Effects

7 documented side effects by frequency

Drug Not Working

1-10%

Fever

1-10%

Nausea

1-10%

Diarrhea

1-10%

Vomiting

1-10%

Fatigue

1-10%

Shortness of Breath

0.1-1%

Community Discussions

2 Reddit threads analysed for GEMCITABINE INTRAVESICAL

Overall Sentiment

Slightly positive

Comparison Threads

Avg Post Score

162 upvotes

Most discussed side effects in community

Edema (1)

Patient Experiences (r/pharmacy, r/AskDocs & more)

MD Pathology as a branch

For my introduction, Hey everyone I'm currently pursuing MD Pathology from a central institute. I'm making this post because u/CupNo5298 suggested that I should share my views on Pathology as a branch and what to expect from it. Pathology needs no introduction regarding it's importance as a branch.

r/indianmedschool236658mo ago

Edema

GOOD NEWS NEWS NEWS ! NCCN updated guidelines are out see table below

https://preview.redd.it/q3tid1645hpg1.png?width=1872&format=png&auto=webp&s=f952755aace12b2b665b089258391865dbd74dd9

r/IBRX87382mo ago

Community discussions are sourced from public Reddit threads. Content reflects individual opinions and is not medical advice.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → GEMCITABINE INTRAVESICAL openFDA label JSON → GEMCITABINE INTRAVESICAL FAERS adverse-event reports → GEMCITABINE INTRAVESICAL ClinicalTrials.gov → completed Phase 2+ trials of GEMCITABINE INTRAVESICAL

Compare With

0 available comparisons

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Formulations

Dosage Forms

Tablet

Route

Intravesical