Screening report

Jazz Pharmaceuticals, Inc. · Package insert of record

ZEPZELCA (Lurbinectedin)

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: not found
Developmental: present in the label
Reproductive: not found
Genotoxicity: not found
Organ toxicity: present in the label
Manufacturer special-handling information
5 passages in the label

“…Administration and Storage ZEPZELCA is a hazardous drug. Follow applicable special handling and disposal procedures 1 . Preparation • Inject 8 mL of Sterile Water for Injectio…”

2 more passages

“…Figure 1 Figure 2 15 REFERENCES 1. "OSHA Hazardous Drugs." OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html 16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ZEPZELCA…”

“…ZEPZELCA is a hazardous drug. Follow applicable special handling and disposal procedures 1 . Preparation • Inject 8 mL of Sterile Water for Injection USP into the vial, yielding a solution containi…”

Developmental / embryo-fetal toxicity
14 passages in the label

“…ZEPZELCA based on severity. ( 5.4 ) • Embryo-Fetal Toxicity : Can cause fetal harm. Advise females and males of reproductive potential of the potential risk to a fetus an…”

2 more passages

“…ZEPZELCA in combination with atezolizumab. 5.5 Embryo-Fetal Toxicity Based on animal data and its mechanism of action [see Clinical Pharmacology (12.1) ] ZEPZELCA can cause fetal…”

“…[see Warnings and Precautions (5.4) ] . Embryo-Fetal Toxicity • Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females…”

Organ toxicity (verify at low doses)
12 passages in the label

“…100,000/mm 3 • Resume ZEPZELCA at reduced dose Hepatotoxicity [see Warnings and Precautions (5.2) ] Grade 2 • Withhold ZEPZELCA until Grade ≤ 1 • Resume ZEPZELCA at same dose Gra…”

2 more passages

“…ZEPZELCA based on severity. ( 5.1 ) • Hepatotoxicity : Monitor liver function tests prior to initiating ZEPZELCA, periodically during treatment and as clinically indicat…”

“…64 days and a median duration of 8 days. 5.2 Hepatotoxicity ZEPZELCA can cause hepatotoxicity which may be severe. Monitor liver function tests prior to initiating ZEPZELCA and…”

Set aside: found but not counted (3)
NegatedCarcinogenicity: “BSEP, MATE1, OAT1, OAT3, or OCT2. 13 13.1 Carcinogenicity testing of lurbinectedin has not been performed. Lurbinectedin is genotoxic to mammalian cells in the presence and”
NegatedGenotoxicity / mutagenicity: “of metabolic activation. Lurbinectedin was not mutagenic in vitro in a bacterial reverse mutation (Ames) assay. Fertility studies with lurbinectedin were not performed. There”
NegatedGenotoxicity / mutagenicity: “has not been performed. Lurbinectedin is genotoxic to mammalian cells in the presence and absence of metabolic activation. Lurbinectedin was not mutagenic in vitro in a”
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.