Screening report

Gilead Sciences, Inc. · Package insert of record

TRODELVY (SACITUZUMAB GOVITECAN)

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).
4 / 6NIOSH hazard criteria present in this label
Special handling: present in the label
Carcinogenicity: not found
Developmental: present in the label
Reproductive: present in the label
Genotoxicity: present in the label
Organ toxicity: not found
Manufacturer special-handling information
6 passages in the label

“…and Administration Reconstitution TRODELVY is a hazardous drug. Follow applicable special handling and disposal procedures 1 . Calculate the required dose (mg) of TRODELVY based on t…”

2 more passages

“…Figure 3 Figure 4 15 REFERENCES 1. “OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html . 16 HOW SUPPLIED/STORAGE AND HANDLING TRODELVY (sacituzuma…”

“…per vial For intravenous infusion only Warning: Hazardous Drug Single-dose vial Discard unused portion 90370103 PRINCIPAL DISPLAY PANEL - 180 mg Vial Label PRINCIPAL DISPLAY PANEL -…”

Genotoxicity / mutagenicity
4 passages in the label

“…to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells [see Clinical Pharmacology (12.1) and (13.1) ]. Advise pregnan…”

2 more passages

“…the drug-associated risk. TRODELVY contains a genotoxic component, SN-38, and is toxic to rapidly dividing cells [see Clinical Pharmacology (12.1) and (13.1) ] . Advise pr…”

“…last dose. Males Because of the potential for genotoxicity, advise male patients with female partners of reproductive potential to use effective contraception during treatme…”

Developmental / embryo-fetal toxicity
13 passages in the label

“…on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-3…”

2 more passages

“…following initiation of TRODELVY. ( 5.5 ) Embryo-Fetal Toxicity : TRODELVY can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contracepti…”

“…[see Dosage and Administration (2.4) ]. 5.6 Embryo-Fetal Toxicity Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when adminis…”

Reproductive / fertility toxicity
4 passages in the label

“…of reproductive potential that TRODELVY may impair fertility [see (8.3) ]. Manufactured by: Gilead Sciences, Inc. 333 Lakeside Dr. Foster City, CA 94404, USA U.S. License No. 225…”

2 more passages

“…after the last dose of TRODELVY [see (8.2) ]. Infertility Advise females of reproductive potential that TRODELVY may impair fertility [see (8.3) ]. Manufactured by: Gilead Sci…”

Animal study“…Based on findings in animals, TRODELVY may impair fertility in females of reproductive potential [see (13.1) ] . 8.4 Pediatric Use Safety and effectiveness of TRODELVY have not…”

Drug-class hint
Context only · not counted

“…Sacituzumab govitecan-hziy is a Trop-2-directed antibody-drug conjugate. Sacituzumab is a humanized antibody that recognizes Trop-2. The small molecule, SN-38, is a topoisomerase I inhibitor,…”

Set aside: found but not counted (4)
NegatedCarcinogenicity: “govitecan-hziy is unknown. 13 13.1 Carcinogenicity studies have not been conducted with sacituzumab govitecan-hziy. SN-38 was clastogenic in an in vitro mammalian ce”
NegatedGenotoxicity / mutagenicity: “test in Chinese hamster ovary cells and was not mutagenic in an in vitro bacterial reverse mutation (Ames) assay. Fertility studies with sacituzumab govitecan-hziy have not be”
NegatedGenotoxicity / mutagenicity: “with sacituzumab govitecan-hziy. SN-38 was clastogenic in an in vitro mammalian cell micronucleus test in Chinese hamster ovary cells and was not mutagenic in an in vitro b”
NegatedGenotoxicity / mutagenicity: “was clastogenic in an in vitro mammalian cell micronucleus test in Chinese hamster ovary cells and was not mutagenic in an in vitro bacterial reverse mutation (Ames) assay. Ferti”
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.