ZUSDURI

The systemic exposure of mitomycin following instillation of 75 mg of mitomycin as ZUSDURI into the bladder was evaluated pre-instillation and hourly for up to six hours post-instillation in six patients. Mitomycin mean (range) maximum concentration (Cmax) is 2.3 ng/mL (0.2 to 8.9 ng/mL), which is less than 1% of the expected Cmax after intravenous administration.

MetabolismMitomycin is metabolized primarily in the liver, but metabolism occurs in other tissues as well. It is believed that the r...

ENVISION Study The efficacy of ZUSDURI was evaluated in ENVISION (NCT05243550), a single-arm, multicenter trial in 240 adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), of whom 223 were evaluable for response. LG-IR-NMIBC was defined as Ta disease, histologically confirmed by biopsy, having one or two of the following: the presence of multiple tumors, a solitary tumor > 3 cm, and/or early or frequent recurrence (≥ 1 occurrence of LG-NMIBC within 1 year of the current diagnosis). Patients were required to have a previous occurrence of LG-NMIBC (...

The most common (≥ 10%) adverse reactions, including laboratory abnormalities, that occurred in patients were increased creatinine, increased potassium, dysuria, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, increased eosinophils, decreased lymphocytes, urinary tract infection, decreased neutrophils, and hematuria. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact UroGen Pharma at 1-855-987-6436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwat...

ZUSDURI is contraindicated in patients with: Perforation of the bladder [see Warnings and Precautions (5.1) ], Prior hypersensitivity reactions to mitomycin or any component of the product. Perforation of the bladder, ( 4 ) Prior hypersensitivity reaction to mitomycin or any component of the product. ( 4 )

Risks in Patients with Perforated Bladder : Evaluate the bladder before the intravesical instillation of ZUSDURI. Do not administer to patients with a perforated bladder or in whom the integrity of the bladder mucosa has been compromised. ( 4 , 5.1 ). Embryo-Fetal Toxicity : Can cause fetal harm. Advise of potential risk to a fetus and to use effective contraception. ( 5.2 , 8.1 , 8.3 ) 5.1 Risks in Patients with Perforated Bladder ZUSDURI may lead to systemic exposure to mitomycin and severe ad...