SUMMARY

• INLEXZO (gemcitabine intravesical system) is an intravesical drug releasing system (iDRS), referred to as TAR-200 in literature, which contains gemcitabine hydrochloride, a nucleoside metabolic inhibitor.^1,2 
• INLEXZO is a sterile, non-resorbable intravesical system containing the equivalent of 225 mg gemcitabine (present as 256.3 mg of gemcitabine hydrochloride). INLEXZO is a bi-oval-shaped tube containing an almost white to light pink-brown colored gemcitabine component at the center surrounded on each side by off white to light blue-colored osmotic components.² 
  • The gemcitabine component contains 225 mg of gemcitabine and the following inactive ingredients: polyethylene glycol 8000 (8.0 mg), povidone K30 (13.4 mg), and urea (42.6 mg).
  • The osmotic components contain the following inactive ingredients: FD&C Blue No.1 (0.0042 mg), polyethylene oxide 600,000 (72.0 mg), and urea (648.0 mg).
• INLEXZO is inserted into the bladder intravesically, using the co-packaged sterile urinary catheter and a sterile stylet.^2-4
  • The urinary catheter is placed via the urethra into the bladder. INLEXZO is uncurled, loaded into the urinary catheter, and manually advanced with the stylet through the urinary shaft. INLEXZO emerges at the exit port as it is fully deployed into the bladder and INLEXZO returns to its bi-oval shape.^3,4
• The silicone bi-oval-shaped tube contains two lumens, the larger one containing the drug components and silicone spacers, and the smaller one containing a superelastic nitinol wire in a predefined shape (wireform). Both lumens are capped with a silicone adhesive. The lumen containing the gemcitabine and osmotic components has a single delivery orifice and acts as an osmotic pump for controlled release of gemcitabine during the indwelling period. See Figure: INLEXZO iDRS.^2,5

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 22 August 2025.