Screening report

Genentech, Inc. · Package insert of record

POLIVY (POLATUZUMAB 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
5 passages in the label

“…prior to intravenous infusion. POLIVY is a hazardous drug. Follow applicable special handling and disposal procedures. 1 Parenteral drug products should be inspected visually fo…”

2 more passages

“…lasting at least 12 months. 15 REFERENCES "OSHA Hazardous Drugs." OSHA . http://www.osha.gov/SLTC/hazardousdrugs/index.html 16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied POLIVY (…”

“…POLIVY is a hazardous drug. Follow applicable special handling and disposal procedures. 1 Parenteral drug products should be inspected visually for particulate matter and discoloration prior to a…”

Genotoxicity / mutagenicity
4 passages in the label

“…the last dose [see (13.1) ] . Males Based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatm…”

2 more passages

Animal study“…vedotin-piiq 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…”

Animal study“…rat bone marrow micronucleus study through an aneugenic mechanism. MMAE was not mutagenic in the bacterial reverse mutation (Ames) assay or the L5178Y mouse lymphoma forward…”

Developmental / embryo-fetal toxicity
18 passages in the label

“…immediately if extravasation occurs. ( 5.8 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use ef…”

2 more passages

“…judgment of the treating physician. 5.9 Embryo-Fetal Toxicity Based on the mechanism of action and findings from animal studies, POLIVY can cause fetal harm when administer…”

“…of 1.8 mg/kg POLIVY every 21 days resulted in embryo-fetal mortality and structural abnormalities (see Data ) . Advise a pregnant woman of the potential risks to a fetus. D…”

Reproductive / fertility toxicity
3 passages in the label

“…males of reproductive toxicity that POLIVY may impair fertility [See (8.3) ]. POLIVY ® [polatuzumab vedotin-piiq] Manufactured by: Genentech, Inc . A Member of the Roche Group 1 DNA…”

2 more passages

“…2 months after the last dose [see (8.2) ] . Infertility Advise females and males of reproductive toxicity that POLIVY may impair fertility [See (8.3) ]. POLIVY ® [polatuzuma…”

Animal study“…final dose [see Nonclinical Toxicity (13.1) ] . Infertility Females Based on findings in animal studies with MMAE-containing antibody-drug conjugates (ADCs), POLIVY may impair fem…”

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

“…burden or rapidly proliferative tumors. ( 5.6 ) Hepatotoxicity: Monitor liver enzymes and bilirubin. ( 5.7 ) Infusion Site Extravasation Injury: Ensure patent venous access prior…”

2 more passages

“…including tumor lysis syndrome prophylaxis. 5.7 Hepatotoxicity Serious cases of hepatotoxicity that were consistent with hepatocellular injury, including elevations of transaminas…”

“…5.7 Hepatotoxicity Serious cases of hepatotoxicity that were consistent with hepatocellular injury, including elevations of transaminases and/or bilirubin, have occurr…”

Drug-class hint
Context only · not counted

“…Polatuzumab vedotin-piiq is a CD79b-directed antibody-drug conjugate with activity against dividing B cells. The small molecule, MMAE, is an anti-mitotic agent covalently attached to the a…”

Set aside: found but not counted (5)
NegatedCarcinogenicity: “of polatuzumab products is unknown. 13 13.1 Carcinogenicity studies in animals have not been performed with polatuzumab vedotin-piiq or MMAE. MMAE was positive for genotoxici”
NegatedCarcinogenicity: “in patients with previously treated B-cell malignancies at the recommended dosage. 12.3 Pharmacokinetics The exposure parameters of acMMAE and unconjugated MMAE (the cytotoxic”
Supporting onlyCarcinogenicity: “clearance was 0.9 L/day in patients with B-cell malignancies. The median (min, max) unconjugated MMAE terminal half-life was 3.74 days (1.58 to 10.1 days) days after the first pola”
NegatedGenotoxicity / mutagenicity: “through an aneugenic mechanism. MMAE was not mutagenic in the bacterial reverse mutation (Ames) assay or the L5178Y mouse lymphoma forward mutation assay. Fertility studies”
NegatedDevelopmental / embryo-fetal toxicity: “risks to a fetus. Data Animal Data No embryo-fetal development studies in animals have been performed with polatuzumab vedotin-piiq. In an embryo-fetal developmental stud”
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.