Screening report

SEAGEN INC. · Package insert of record

ADCETRIS (BRENTUXIMAB VEDOTIN)

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).
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
4 passages in the label

“…procedures for proper handling and disposal of hazardous drugs 1 . • Use appropriate aseptic technique for reconstitution and preparation of dosing solutions. • Determine the number…”

2 more passages

“…Figure 8 Figure 9 15 REFERENCES 1. OSHA Hazardous Drugs. OSHA . [Accessed on 30 July 2013, from http://www.osha.gov/SLTC/hazardousdrugs/index.html ] 16 HOW SUPPLIED/STORAGE A…”

“…ADCETRIS is a hazardous product. Follow special handling and disposal procedures 1 . 17 PATIENT COUNSELING INFORMATION Peripheral Neuropathy Advise patients that ADCETRIS can cause a periph…”

Genotoxicity / mutagenicity
3 passages in the label
Animal data

“…(MMAE) have not been conducted. MMAE was genotoxic in the rat bone marrow micronucleus study through an aneugenic mechanism. This effect is consistent with the pharmaco…”

2 more passages

“…rat bone marrow micronucleus study through an aneugenic mechanism. This effect is consistent with the pharmacological effect of MMAE as a microtubule-disrupting agent. MMAE…”

“…MMAE was genotoxic in the rat bone marrow micronucleus study through an aneugenic mechanism. This effect is consistent with the pharmacological effect of MMAE as a microtubul…”

Developmental / embryo-fetal toxicity
21 passages in the label

“…medications as clinically indicated ( 5.13 ). • Embryo-Fetal toxicity : Can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductiv…”

2 more passages

“…medications as clinically indicated. 5.14 Embryo-Fetal Toxicity Based on the mechanism of action and findings in animals, ADCETRIS can cause fetal harm when administered to a…”

“…dose of 1.8 mg/kg every three weeks caused embryo-fetal toxicities, including congenital malformations (see Data ). The available data from case reports on ADCETRIS use in pre…”

Reproductive / fertility toxicity
2 passages in the label
Animal data

“…degeneration, Sertoli cell vacuolation, reduced spermatogenesis, and aspermia were observed. Effects in animals were seen mainly at 5 and 10 mg/kg of brentuximab vedotin. These doses…”

1 more passage

“…the last dose of ADCETRIS [see (13.1) ]. Infertility Females Based on findings in animal studies with MMAE-containing antibody-drug conjugates (ADCs), ADCETRIS may impair f…”

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

“…tumor or high tumor burden ( 5.5 ). • Hepatotoxicity : Monitor liver enzymes and bilirubin ( 5.8 ). • Pulmonary toxicity : Monitor patients for new or worsening symptoms…”

2 more passages

“…C) hepatic impairment [see (8.7) ] . 5.8 Hepatotoxicity Fatal and serious cases of hepatotoxicity have occurred in patients receiving ADCETRIS. Cases were consistent with h…”

“…. 5.8 Hepatotoxicity Fatal and serious cases of hepatotoxicity have occurred in patients receiving ADCETRIS. Cases were consistent with hepatocellular injury, including elevations…”

Drug-class hint
Context only · not counted

“…and proliferation. Brentuximab vedotin is an antibody-drug conjugate (ADC). The antibody is a chimeric IgG1 directed against CD30. The small molecule, MMAE, is a microtubule-disrupting age…”

Set aside: found but not counted (4)
NegatedCarcinogenicity: “on efficacy is not known. 13 13.1 Carcinogenicity studies with brentuximab vedotin or the small molecule (MMAE) have not been conducted. MMAE was genotoxic in the r”
Supporting onlyCarcinogenicity: “of disease progression or relapse, second malignancy, or death due to any cause. Efficacy results are summarized in Table 14 . Table 14: Efficacy Results in Pediatric Patie”
NegatedGenotoxicity / mutagenicity: “as a microtubule-disrupting agent. MMAE was not mutagenic in the bacterial reverse mutation assay (Ames test) or the L5178Y mouse lymphoma forward mutation assay. Fertility st”
NegatedGenotoxicity / mutagenicity: “in the bacterial reverse mutation assay (Ames test) or the L5178Y mouse lymphoma forward mutation assay. Fertility studies with brentuximab vedotin or MMAE have not been”
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.