Screening report

Daiichi Sankyo Inc. · Package insert of record

DATROWAY (DATOPOTAMAB DERUXTECAN)

Not on the NIOSH ListDailyMed (opens the full label on DailyMed in a new tab)
Special-handling language in the label
The FDA label carries manufacturer special-handling information — for example cytotoxic, antineoplastic, or “special handling.”
5 / 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: present in the label
Manufacturer special-handling information
6 passages in the label

“…DATROWAY (datopotamab deruxtecan-dlnk) is a hazardous drug. Follow applicable special handling and disposal procedures. 1 Reconstitution Reconstitute immediately before dilution.…”

2 more passages

“…Chemical Structure 15 REFERENCES OSHA Hazardous Drugs. OSHA . http://www.osha.gov/SLTC/hazardousdrugs/index.html 16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied DATROWAY…”

“…the enclosed Medication Guide to each patient. Hazardous Drug KEEP REFRIGERATED 1 vial Daiichi-Sankyo AstraZeneca PRINCIPAL DISPLAY PANEL - 100 mg Vial Carton…”

Genotoxicity / mutagenicity
4 passages in the label

“…of DATROWAY, DXd [see Description (11) ] , is genotoxic and affects actively dividing cells [see (8.1) , Clinical Pharmacology (12.1) , (13.1) ]. Advise patients of the…”

2 more passages

“…inhibitor component of DATROWAY, DXd, is genotoxic and affects actively dividing cells [see Clinical Pharmacology (12.1) , (13.1) ] . There are no available data on t…”

“…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
12 passages in the label

“…DATROWAY based on severity. ( 2.3 , 2.4 , 5.3 ) Embryo-Fetal Toxicity : DATROWAY can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contracepti…”

2 more passages

“…[see Dosage and Administration (2.4) ]. 5.4 Embryo-Fetal Toxicity Based on its mechanism of action, DATROWAY can cause embryo-fetal harm when administered to a pregnant woman b…”

“…on its mechanism of action, DATROWAY can cause embryo-fetal harm when administered to a pregnant woman because the topoisomerase inhibitor component of DATROWAY, DXd [see Descript…”

Reproductive / fertility toxicity
5 passages in the label

“…not to breastfeed. ( 8.2 ) Infertility: May impair fertility in males and females. ( 8.3 ) 8.1 Pregnancy Risk Summary Based on its mechanism of action, DATROWAY can cause embryo-fe…”

2 more passages

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

“…Lactation: Advise not to breastfeed. ( 8.2 ) Infertility: May impair fertility in males and females. ( 8.3 ) 8.1 Pregnancy Risk Summary Based on its mechanism of action, DATROW…”

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

“…(NCI CTCAE) version 5.0. Dosage Modifications Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions (5.1) ] Asymptomatic ILD/pneumonitis Grade 1 Withhold DATROWAY until IL…”

2 more passages

“…None. None. ( 4 ) 5 WARNINGS AND PRECAUTIONS Interstitial Lung Disease (ILD) and Pneumonitis: DATROWAY can cause severe and fatal cases of ILD/pneumonitis. Monitor for new or worsening signs…”

“…contraception. ( 5.4 , 8.1 , 8.3 ) 5.1 Interstitial Lung Disease/Pneumonitis DATROWAY can cause severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis. Local…”

Drug-class hint
Context only · not counted

“…conjugate. Datopotamab deruxtecan-dlnk is an antibody-drug conjugate (ADC) composed of three components: 1) a humanized anti-Trop-2 IgG1 monoclonal antibody (mAb), covalently linked to 2)…”

Set aside: found but not counted (6)
NegatedCarcinogenicity: “deruxtecan-dlnk was observed. 13 13.1 Carcinogenicity studies have not been conducted with datopotamab deruxtecan-dlnk. The topoisomerase inhibitor component of datopot”
NegatedGenotoxicity / mutagenicity: “lung chromosome aberration assay and was not mutagenic in an in vitro bacterial reverse mutation assay. Dedicated fertility studies have not been conducted with datopotamab”
NegatedGenotoxicity / mutagenicity: “of datopotamab deruxtecan-dlnk, 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. Dedicated fertility studies have not been”
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 datopotamab deruxtecan-dlnk. 8.2 Lactation Risk Summary There are no data regarding the presence”
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.