Screening report

Daiichi Sankyo Inc. · Package insert of record

Enhertu (FAM-TRASTUZUMAB DERUXTECAN-NXKI)

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).
6 / 6NIOSH hazard criteria present in this label
Special handling: present in the label
Carcinogenicity: present in the label
Developmental: present in the label
Reproductive: present in the label
Genotoxicity: present in the label
Organ toxicity: present in the label
Manufacturer special-handling information
8 passages in the label

“…ENHERTU (fam-trastuzumab deruxtecan-nxki) is a hazardous drug. Follow applicable special handling and disposal procedures. 1 Reconstitution Reconstitute immediately before dilution.…”

2 more passages

“…Cell Carcinoma 1 PD NA 15 REFERENCES OSHA Hazardous Drugs. OSHA . http://www.osha.gov/SLTC/hazardousdrugs/index.html 16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied/Storage E…”

“…Single-Dose Vial Discard Unused Portion Hazardous Drug KEEP REFRIGERATED 1 vial Daiichi-Sankyo AstraZeneca PRINCIPAL DISPLAY PANEL - 100 mg Vial Carton…”

Carcinogenicity
1 passage in the label

“…of patients including pneumonitis (2 patients), acute myeloid leukemia, brain edema, COVID-19, hemorrhage, hepatitis B, malignant pleural effusion, pneumonia, and vasogenic cerebral edema (o…”

Genotoxicity / mutagenicity
4 passages in the label

“…administered to a pregnant woman because it is genotoxic and targets actively dividing cells [see (8.1) , Clinical Pharmacology (12.1) , (13.1) ] . Advise patients of the…”

2 more passages

“…administered to a pregnant woman because it is genotoxic and targets actively dividing cells [see Clinical Pharmacology (12.1) , (13.1) ] . Advise patients of the potential…”

“…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
20 passages in the label

“…80 WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY Interstitial Lung Disease (ILD) and pneumonitis, including severe, life-threatening, and fatal cases, have bee…”

2 more passages

“…(2.3) , Warnings and Precautions (5.1) ] . Embryo-Fetal Toxicity: Exposure to ENHERTU during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need…”

“…Exposure to ENHERTU during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception [see Warnings and Precautions (5.4) , (…”

Reproductive / fertility toxicity
3 passages in the label

“…of reproductive potential that ENHERTU may impair fertility [see (8.3) ] . Manufactured by: Daiichi Sankyo, Inc., Basking Ridge, NJ 07920 U.S. License No. 2128 Marketed by: Daii…”

2 more passages

“…after the last dose of ENHERTU [see (8.2) ] . Infertility Advise males of reproductive potential that ENHERTU may impair fertility [see (8.3) ] . Manufactured by: Daiichi Sank…”

Animal study“…4 months after the last dose [see (13.1) ] . Infertility Based on findings in animal toxicity studies, ENHERTU may impair male reproductive function and fertility [see (13.1)…”

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

“…MONOHYDRATE SUCROSE POLYSORBATE 80 WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY Interstitial Lung Disease (ILD) and pneumonitis, including severe, life-threatening, and fata…”

2 more passages

“…LUNG DISEASE and EMBRYO-FETAL TOXICITY Interstitial Lung Disease (ILD) and pneumonitis, including severe, life-threatening, and fatal cases, have been reported with ENHERTU. Monitor fo…”

“…Precautions (5.4) , (8.1 , 8.3) ] . WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. Interstitial lung disease (ILD)…”

Drug-class hint
Context only · not counted

“…Fam-trastuzumab deruxtecan-nxki is an antibody-drug conjugate (ADC) composed of three components: 1) a humanized anti-HER2 IgG1 monoclonal antibody (mAb), covalently linked to 2) a…”

Set aside: found but not counted (6)
NegatedCarcinogenicity: “in combination with pertuzumab. 13 13.1 Carcinogenicity studies have not been conducted with fam-trastuzumab deruxtecan-nxki. The topoisomerase inhibitor component of fam”
NegatedGenotoxicity / mutagenicity: “lung chromosome aberration assay and was not mutagenic in an in vitro bacterial reverse mutation assay. Fertility studies have not been conducted with fam-trastuzumab derux”
NegatedGenotoxicity / mutagenicity: “of fam-trastuzumab deruxtecan-nxki, DXd, was clastogenic in both an in vivo rat bone marrow micronucleus assay and an in vitro Chinese hamster lung chromosome aberration assa”
NegatedGenotoxicity / mutagenicity: “assay and an in vitro Chinese hamster lung chromosome aberration assay and was not mutagenic in an in vitro bacterial reverse mutation assay. Fertility studies have not been conducted”
NegatedGenotoxicity / mutagenicity: “clastogenic in both an in vivo rat bone marrow micronucleus assay and an in vitro Chinese hamster lung chromosome aberration assay and was not mutagenic in an in vitro bacterial r”
NegatedDevelopmental / embryo-fetal toxicity: “Data There were no animal reproductive or developmental toxicity studies conducted with fam-trastuzumab deruxtecan-nxki. 8.2 Lactation Risk Summary There is no data regarding the prese”
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.