Overview
Inlexzo is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. This treatment is intended for individuals whose bladder cancer has not responded to standard BCG therapy. Inlexzo is also known by its drug name, gemcitabine.

Inlexzo is a nucleoside metabolic inhibitor. It is believed to work by interfering with the DNA of cancer cells, preventing them from growing and multiplying in the lining of the bladder.

How do I take it?
Prescribing information states that Inlexzo is inserted directly into the bladder using a urinary catheter and stylet. The treatment is given once every three weeks for up to six months (total of eight doses), followed by one dose every 12 weeks (total of six doses). Each dose is removed after a three-week period. Inlexzo should be administered exactly as prescribed by a healthcare provider.

Side effects
Common side effects of Inlexzo include urinary frequency, urinary tract infection, dysuria (painful urination), micturition urgency (urgent need to urinate), urinary tract pain, bladder irritation, and hematuria (blood in the urine). Laboratory changes such as decreased hemoglobin, decreased lymphocytes, increased lipase, increased creatinine, increased potassium, increased liver enzymes (AST and ALT), and decreased sodium may also occur.

Rare but serious side effects may include bladder perforation, hypersensitivity reactions, and the risk of developing metastatic (spreading) bladder cancer if cystectomy (bladder removal) is delayed. Inlexzo may also cause fetal harm, so effective contraception is advised, and breastfeeding should be avoided. Special precautions must be taken before undergoing MRI imaging while receiving this treatment.

For more information about this treatment, visit:
Inlexzo (Gemcitabine Intravesical System) — Janssen Biotech