zusduri
Zusduri (Mitomycin) is an alkylating drug used to treat Adenocarcinoma, Urinary Bladder Neoplasms, Pancreatic Neoplasms, Stomach Neoplasms.
Mitomycin · by Urogen Pharma
Available as a generic: Mitomycin
Key facts
- Active ingredient
- Mitomycin
- Drug class
- Alkylating Drug
- Form
- Kit
- Strength
- Mitomycin 40MG/VIAL
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Urogen Pharma
- FDA application
- NDA215793
What is Zusduri?
From the FDA label:Mitomycin (also known as mitomycin-C) is an alkylating drug isolated from the broth of Streptomyces . Mitomycin is a blue-violet crystalline powder with a molecular formula of C 15 H 18 N 4 O 5 , and a molecular weight of 334.33. Its chemical name is 7-amino-9α-methoxymitosane, and it has the following structural formula: Mitomycin is heat stable, has a high melting point, and is freely soluble in organic solvents. ZUSDURI is supplied in a kit containing two vials of sterile lyophilized mitomycin for intravesical solution, 40 mg each, and one vial of 60 mL of sterile hydrogel, to be used as a vehicle for reconstitution. Mitomycin for intravesical solution is a sterile, lyophilized, grey to greyish-purple, cake or powder that contains mitomycin 40 mg and mannitol 80 mg in each vial. Hydrogel is a sterile, clear, colorless gel with or without bubbles at room temperature or clear, colorless liquid at 2°C to 8°C (36°F to 46°F), which contains 0.11 g hydroxypropyl methylcellulose, 17.12 g poloxamer, 0.63 g polyethylene glycol, and water for injection in each vial. Once reconstituted, ZUSDURI is a clear, purple, viscous liquid at 2°C to 8°C (36°F to 46°F) or semisolid gel at room temperature, which may contain a few visible particles and have a pH between 6.0 and 8.0. Chemical Structure
How to use
Administer ZUSDURI by intravesical instillation only. Do not administer by pyelocalyceal instillation or by any other route. ( 2.1 ) The recommended dose of ZUSDURI is 75 mg (56 mL) instilled once weekly for six weeks. ( 2.2 ) 2.1 Important Administration Instructions Administer ZUSDURI by intravesical instillation only. Do not administer by pyelocalyceal instillation or by any other route. 2.2 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. [see Dosage and Administration (2.4) ] 2.3 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. Storage Instructions for Reconstituted ZUSDURI: Instill reconstituted ZUSDURI as soon as possible. If not used immediately, store reconstituted ZUSDURI: under refrigeration at 2℃ to 8℃ (36°F to 46°F) for up to 7 days; or under refrigeration at 2℃ to 8℃ (36°F to 46°F) for up to 6 days followed by no more than 24 hours at room temperature, 20°C to 25°C (68°F to 77°F). Discard 7 days after reconstitution.…
Side effects
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/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice. The safety of ZUSDURI was evaluated in ENVISION, a single-arm, multicenter study in 240 patients with recurrent LG-IR-NMIBC [see Clinical Studies (14) ]. Patients received 75 mg ZUSDURI instilled once a week for 6 consecutive weeks. The median number of doses of ZUSDURI administered to patients was 6 (range 1-6) doses and 228 patients (95%) received all six scheduled doses. Serious adverse reactions occurred in 12% of patients who received ZUSDURI, including urinary retention (0.8%) and urethral stenosis (0.4%). A fatal adverse reaction of cardiac failure occurred in 1 patient (0.4%) receiving…
Warnings
Important safety information
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 adverse reactions if administered to patients with a perforated bladder or to those in whom the integrity of the bladder mucosa has been compromised. Evaluate the bladder before the intravesical instillation of ZUSDURI and do not administer to patients with a perforated bladder or mucosal compromise until bladder integrity has been restored [see Contraindications (4) ]. 5.2 Embryo-Fetal Toxicity Based on findings in animals and mechanism of action, ZUSDURI can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of mitomycin resulted in teratogenicity. Advise females of reproductive potential to use effective contraception during treatment with ZUSDURI and for 6 months following the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ZUSDURI and for 3 months following the last dose [see Use in Specific Populations (8.1 , 8.3) and Clinical Pharmacology (12.1) ].
Who should not take Zusduri
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 )
Storing Zusduri, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Discard 7 days after reconstitution.”
Drug class
How this class works, per Cyclophosphamide — StatPearls, NCBI Bookshelf (NIH).
May treat (source: NIH RxClass)
See how Zusduri ranks — best-rated alkylating drug for:
Dosage forms
Kit
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Zusduri treat?
- Zusduri (Mitomycin) may be used to treat adenocarcinoma, urinary bladder neoplasms, pancreatic neoplasms, stomach neoplasms, colorectal neoplasms, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Zusduri work?
- Zusduri is a alkylating drug. Alkylating chemotherapy drugs attach chemical groups to a cell's DNA, forming cross-links that lock the two DNA strands together. This damage stops the cell from copying its DNA and dividing, which triggers it to die; because they are not limited to one phase of the cell cycle, they can act on cells whether or not they are actively dividing.
- Is there a coupon or discount for Zusduri?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Zusduri. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Zusduri?
- Zusduri is marketed by Urogen Pharma. You can see Urogen Pharma's full profile, rating, and other products on pharmaranks.
- Is Zusduri a brand-name or generic drug?
- Zusduri is a brand-name product with the active ingredient Mitomycin. Lower-cost generic equivalents containing Mitomycin are available — ask your pharmacist.
- Is Zusduri available over the counter?
- No. Zusduri is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Zusduri come in?
- Zusduri is currently marketed as kit, per the FDA's National Drug Code Directory.
- What class of drug is Zusduri?
- Zusduri is classified as alkylating drug, per the FDA's Established Pharmacologic Class.
- Is Zusduri FDA-registered?
- Zusduri is on record with the U.S. FDA under application number NDA215793. You can verify this on its official FDA label.
- Is Zusduri safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Zusduri. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Zusduri?
- Zusduri's side effects are taken directly from its FDA label. From the label: 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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