Initial US Approval:
1974
Key Clinical Studies:
ENVISION (NCT05243550)
Drug Class/Description:
Alkylating drug
Indications and Usage:
ZUSDURI is an alkylating drug indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
Dosage and Administration:
Administer ZUSDURI by intravesical instillation only. Do not administer by pyelocalyceal instillation or by any other route.
The recommended dose of ZUSDURI is 75 mg (56 mL) instilled once weekly for six weeks.
Dosage Forms and Strengths:
For intravesical solution: A kit containing the following:
- Two 40 mg (each) single-dose vials of mitomycin for intravesical solution.
- One vial of 60 mL sterile hydrogel for reconstitution.
Contraindications:
- Perforation of the bladder,
- Prior hypersensitivity reaction to mitomycin or any component of the product.
Warnings and Precautions:
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.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus and to use effective contraception.
Adverse Reactions:
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.
Use in Specific Populations:
Lactation: Advise not to breastfeed.
Adapted From:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215793s000lbl.pdf
Every health-care provider should make their own determination regarding specific safe and appropriate patient care practices, including drug dosages and indications. The provider should always consult the most recent prescribing/product information. FDA Focus information is not guaranteed to be accurate, complete, or current. JADPRO and its editors, authors, reviewers, and commentators cannot be held responsible for any liability incurred as a consequence of the application of any of the information listed within.
