Zusduri Dosage

Important Administration Instructions

Administer ZUSDURI by intravesical instillation only. Do not administer by pyelocalyceal instillation or by any other route.

Recommended Dose

The recommended dose of ZUSDURI is 75 mg (56 mL) instilled once weekly for six weeks into the bladder via a urinary catheter.

Preparation Instructions

See the Instructions for Pharmacy enclosed in the carton for complete information on preparation.

ZUSDURI must be reconstituted with sterile hydrogel under chilled conditions. Reconstituted ZUSDURI has reverse thermal properties with a gelation point of approximately 19°C (66°F) and will appear as a viscous liquid under chilled conditions and a semisolid gel at room temperature.

Bladder Instillation of ZUSDURI

See the Instructions for Administration enclosed in the carton for complete information on bladder instillation.

ZUSDURI must be chilled at -3°C to 5°C (27°F to 41°F) to convert to a viscous liquid prior to instillation. When instilling ZUSDURI, each syringe must be emptied within thirty (30) seconds to avoid gelation.

Instillation of ZUSDURI requires syringes and a urinary catheter with fixed Luer Lock connectors.

Advise patients that ZUSDURI may discolor urine to a violet to blue color following the instillation procedure. Advise patients for at least 24 hours post-instillation to avoid urine contact with skin, to void urine sitting on a toilet, to wash hands and genital area with water and soap after each urination, and to flush the toilet several times after use.