Screening report

UroGen Pharma, Inc · Package insert of record

ZUSDURI (MITOMYCIN)

NIOSH Table 1DailyMed (opens the full label on DailyMed in a new tab)
On the NIOSH List — Table 1
This drug appears on the NIOSH List of Hazardous Drugs, 2024 (Table 1).
3 / 6NIOSH hazard criteria present in this label
Special handling: present in the label
Carcinogenicity: present in the label
Developmental: present in the label
Reproductive: not found
Genotoxicity: not found
Organ toxicity: not found
Manufacturer special-handling information
14 passages in the label

“…excessive heat over 40°C (104°F). ZUSDURI is a hazardous drug. Follow applicable special handling and disposal procedures. 1 2.4 Bladder Instillation of ZUSDURI See the Instructions…”

2 more passages

“…≥ 12 months 79% (137) 15 REFERENCES "OSHA Hazardous Drugs." OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html 16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ZUSDURI i…”

“…excessive heat over 40°C (104°F). ZUSDURI is a hazardous drug. Procedures for Proper Handling and Disposal of hazardous drugs should be followed. Supplies Needed ZUSDURI available i…”

Carcinogenicity
3 passages in the label

“…produced a greater than 100% increase in tumor incidence in male Sprague-Dawley rats, and a greater than 50% increase in tumor incidence in female Swiss mice. The effect of ZUS…”

2 more passages

“…rats, and a greater than 50% increase in tumor incidence in female Swiss mice. The effect of ZUSDURI on fertility is unknown. 14 CLINICAL STUDIES ENVISION Study The efficacy of…”

Animal study“…been conducted. Mitomycin has been found to be carcinogenic in rats and mice. At doses approximating the recommended intravenous clinical dose in humans, mitomycin produced a gr…”

Developmental / embryo-fetal toxicity
16 passages in the label

“…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 ,…”

2 more passages

“…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 preg…”

“…patient labeling (Patient Information). Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females t…”

Set aside: found but not counted (1)
NegatedCarcinogenicity: “long-term studies in animals to evaluate carcinogenic potential from instillation of mitomycin into the bladder have not been conducted. Mitomycin has been found to be car”
These matched a hazard term but the text negates the finding, or names a test, a disease or a drug class rather than a finding about this drug. Shown so you can review them yourself.

For information only. This is a count of how many of the six NIOSH hazard-criteria appear in this label after negated and supporting-only statements are set aside. Findings from animal studies count, as NIOSH’s definition counts them, and are tagged “Animal data”. It is not a hazard determination, and the drug-class hint is not counted.