Disclaimer:

TAR-200 is an investigational product, and the safety and efficacy of the product has not yet

been determined. There is no guarantee that TAR-200 will be filed with and/or approved for

marketing by the FDA or other Health Authorities. For additional information, you may visit www.clinicaltrials.gov

 

Chapter 1: Introduction

The purpose of this video is to provide an overview of the insertion and removal

procedures of TAR-200 and should not be used in place of the TAR-200 Instructions for Use

(IFU).

 

Chapter 2: Preparation and TAR-200 System

Personal protective equipment should be used while handling TAR-200, and during the insertion procedure.¹

Use clean technique throughout the insertion procedure.

Remove the contents of the TAR-200 packaging.

The packaging contains: TAR-200 in a foil pouch and co-packaged urinary placement catheter with stylet (UPC).²

Other materials needed for the procedure but not included with the packaging are two Luer-lock or slip tip syringes filled with water-based lubricant.

Visually inspect TAR-200 and all component pouches for damage including rips, tears, or punctures. DO NOT use any component that is damaged or has damaged packaging.1

 

Remove TAR-200 from the foil pouch.

This is an enlarged view of TAR-200, it can be compared to the size of a quarter or two-euro coin.²

TAR-200 has a drug component consisting of gemcitabine and urea minitablets, and a drug releasing component consisting of a dual lumen silicone tube. The drug component minitablets are contained within the large lumen of the silicone tube, where the urea minitablets act as an osmotic pump for controlled gemcitabine release.2 The smaller lumen contains a nitinol wire that takes a predefined bi-oval shape to ensure bladder retention for the duration of the indwelling period during which TAR-200 is designed to provide sustained, local delivery of gemcitabine in the bladder.²

 

Place TAR-200 and both the catheter and stylet of the UPC on a sterile tray.¹

If not already prefilled, fill two syringes with 2 to 3 mL water-based lubricant, and place them on the sterile tray.¹

 

Chapter 3: TAR-200 Insertion

Prepare patient for direct catheterization, lubricate the tip of the catheter shaft and advance it into the urethra until urine return occurs.¹

Note the depth marking printed on the catheter shaft and maintain this point throughout the procedure.¹

 

Use one lubricant syringe to inject 2-3mL of lubricant into the catheter shaft.¹

 

Insert either end of TAR-200 by hand into the catheter shaft.¹

 

Advance TAR-200 into the catheter shaft until it is completely uncoiled within.¹ If TAR-200 cannot be advanced due to resistance not typically experienced with catheter insertion, remove the catheter and stylet as one unit, ensuring TAR-200 is removed as well.¹

DO NOT attempt to place the removed TAR-200 again, Open and use a new TAR-200 for subsequent attempts.¹

 

Once TAR-200 has been advanced completely by hand, use the second lubricant syringe to inject an additional 2-3 mL of lubricant into the catheter.¹

Slowly advance the stylet through the catheter shaft until the stylet hub is in flush contact with the proximal end of the catheter.¹

This will ensure that TAR-200 completely exits the catheter into the bladder.¹

Remove the catheter and stylet from the urethra together. TAR-200 should remain in the bladder.¹

 

Chapter 4: TAR-200 Removal

Prepare the patient for cystoscopy procedure in accordance with institutional standard of care and introduce a cystoscope through the urethra into the bladder.¹

 

Visually inspect the bladder to locate TAR-200. Introduce non-cutting, grasping forceps into the working channel of the cystoscope. Grasp TAR-200 over the tubing and wireform.¹

Do not grasp on or near the ends of TAR-200.¹

 

While grasping TAR-200, remove the cystoscope and forceps from the urethra together as one unit removing TAR-200 under direct vision.¹

Do not pull TAR-200 through the working channel of the cystoscope.¹

Inspect the removed TAR-200 to ensure that it is intact and unbroken, then discard in accordance with institutional biohazard policies.

 

For additional information or questions please contact your MSL.

 

References:

1. Data on File. Janssen Scientific Affairs, LLC. TAR-200 Instructions for Use. TV-ART-04992.
2. Daneshmand S, et al. Urol Oncol. 2022;40:344.e1-344.e9.
3. Data on File. Janssen Scientific Affairs, LLC. Clinical Protocol 17000139BLC3002.

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