Screening report

SEAGEN INC. · Package insert of record

TIVDAK (TISOTUMAB 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
10 passages in the label

“…as an intravenous infusion only. • TIVDAK is a hazardous drug. Follow applicable special handling and disposal procedures 1 . • DO NOT administer TIVDAK as an intravenous push or bo…”

2 more passages

“…8.3 (4.2, NR) 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 TIVDAK (t…”

“…Do not shake. Special Handling TIVDAK is a hazardous drug. Follow special handling and disposal procedures. 1 17 PATIENT COUNSELING INFORMATION Advise the patient to read the FD…”

Genotoxicity / mutagenicity
3 passages in the label
Animal data

“…vedotin-tftv or MMAE. MMAE was positive for genotoxicity in the in vivo rat bone marrow micronucleus study through an aneugenic mechanism. MMAE was not mutagenic in the ba…”

2 more passages

“…rat bone marrow micronucleus study through an aneugenic mechanism. MMAE was not mutagenic in the bacterial reverse mutation (Ames) assay or the L5178 TK +/- mouse lymphoma f…”

“…for genotoxicity in the in vivo rat bone marrow micronucleus study through an aneugenic mechanism. MMAE was not mutagenic in the bacterial reverse mutation (Ames) assay or the L517…”

Developmental / embryo-fetal toxicity
18 passages in the label

“…reactions, including SJS. ( 2.3 , 5.5 ) • Embryo-fetal toxicity: TIVDAK can cause fetal harm. Advise of the potential risk to a fetus and to use effective contraception. ( 5.…”

2 more passages

“…[see Dosage and Administration (2.3) ] . 5.6 Embryo-Fetal Toxicity Based on the mechanism of action and findings in animals, TIVDAK can cause fetal harm when administered to a p…”

“…to pregnant rats during organogenesis caused embryo-fetal mortality and structural abnormalities at exposures below the clinical exposure at the recommended dose (see Data ) . A…”

Reproductive / fertility toxicity
1 passage in the label
Animal data

“…TIVDAK and for 4 months after the last dose. Infertility Females Based on findings in animal studies with MMAE-containing antibody-drug conjugates (ADCs), TIVDAK may impair fem…”

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

“…any other location Any Permanently discontinue. Pneumonitis [see Warnings and Precautions (5.4) ] Grade 2 Any Withhold dose until Grade ≤1 for persistent or recurrent pneumonitis,…”

2 more passages

“…dose until Grade ≤1 for persistent or recurrent pneumonitis, consider resuming treatment at next lower dose level. Grade 3 or 4 Any Permanently discontinue. Severe cutaneous adver…”

“…TIVDAK based on severity. ( 2.3 , 5.3 ) • Pneumonitis: Severe, life-threatening, or fatal pneumonitis may occur. Withhold TIVDAK for persistent or recurrent Grade 2 pneumoni…”

Drug-class hint
Context only · not counted

“…pneumonitis can occur in patients treated with antibody drug conjugates containing vedotin including TIVDAK. Among patients with cervical cancer treated with TIVDAK across clinical trials, 4…”

Set aside: found but not counted (3)
NegatedCarcinogenicity: “efficacy or safety. 13 13.1 Carcinogenicity studies in animals have not been performed with tisotumab vedotin-tftv or MMAE. MMAE was positive for genotoxicity”
NegatedGenotoxicity / mutagenicity: “through an aneugenic mechanism. MMAE was not mutagenic in the bacterial reverse mutation (Ames) assay or the L5178 TK +/- mouse lymphoma forward mutation assay. Fertility s”
NegatedDevelopmental / embryo-fetal toxicity: “risk to a fetus. Data Animal Data No embryo-fetal development studies in animals have been performed with tisotumab vedotin-tftv. In an embryo-fetal development study in”
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.