Screening report

AbbVie Inc. · Package insert of record

DECNUPAZ (PIVEKIMAB SUNIRINE-PVZY)

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
11 passages in the label

“…technique to prepare DECNUPAZ. DECNUPAZ is a hazardous drug. Follow applicable special handling and disposal procedures in accordance with local requirements. 1 Determine the dose…”

2 more passages

“…b Kaplan-Meier estimate. 15. REFERENCES 1 “OSHA Hazardous Drugs.” OSHA http://www.osha.gov/SLTC/hazardousdrugs/index.html 16. HOW SUPPLIED/STORAGE AND HANDLING How Supplied DECNUPAZ…”

“…for injection 2 mg per vial WARNING: Hazardous Drug For intravenous infusion after reconstitution and two dilutions 1 Single-dose Vial Discard Unused Portion Dispense the…”

Genotoxicity / mutagenicity
6 passages in the label

“…to a pregnant woman because it contains a genotoxic compound (FGN849) and affects actively dividing cells [see Clinical Pharmacology ( 12.1 ), ( 13.1 )] . Advise patie…”

2 more passages

Animal study“…sunirine-pvzy or the small molecule FGN849. Mutagenesis FGN849 was mutagenic in the bacterial reverse mutation (Ames) assay and clastogenic in the in vitro and in vivo (ra…”

Animal study“…small molecule FGN849. Mutagenesis FGN849 was mutagenic in the bacterial reverse mutation (Ames) assay and clastogenic in the in vitro and in vivo (rat) micronucleus assays.…”

Developmental / embryo-fetal toxicity
14 passages in the label

“…potential to cause embryofetal lethality and teratogenicity. 8.2 Lactation Risk Summary There are no data on the presence of pivekimab sunirine-pvzy or its metabolites in hum…”

2 more passages

“…episodes in certain susceptible people. ( 5.4 ) Embryo-fetal toxicity : Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. (…”

“…in asthmatic than in non-asthmatic people. 5.5 Embryo-Fetal Toxicity Based on its mechanism of action, DECNUPAZ can cause embryo-fetal harm when administered to a pregnant woman b…”

Reproductive / fertility toxicity
3 passages in the label

“…not to breastfeed ( 8.2 ) Infer tility : May impair fertility ( 8.3 ) Moderate to Severe Hepatic Impairment : Avoid use of DECNUPAZ ( 8.7 ) Moderate to Severe Renal Impairment : Avo…”

2 more passages

“…4 months after the last dose [see ( 13.1 )] . Infertility Based on its mechanism of action, DECNUPAZ may impair male and female reproductive function and fertility. 8.4 Pediatri…”

“…4 months after the last dose [see ( 8.3 )] . Infertility Advise females and males of reproductive potential that DECNUPAZ may impair reproductive function and fertility [see…”

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

“…20 WATER METHIONINE white to off-white WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) DECNUPAZ can cause h…”

2 more passages

“…OBSTRUCTION SYNDROME) DECNUPAZ can cause hepatotoxicity, including severe or fatal hepatic VOD (also known as sinusoidal obstruction syndrome) [see Warnings and Precautions…”

“…complete boxed warning. VOD, a severe form of hepatotoxicity, has been reported in patients with BPDCN treated with DECNUPAZ, including severe or fatal hepatic VOD. ( 5.1 ) Clos…”

Drug-class hint
Context only · not counted

“…G4723A to the DGN549C linker-payload. The antibody-drug conjugate (ADC) contains approximately two DGN549C molecules sulfonated prior to conjugation and bound to the heavy chains (HC) o…”

Set aside: found but not counted (4)
NegatedCarcinogenicity: “of pivekimab sunirine-pvzy. 13. 13.1 Carcinogenesis Carcinogenicity studies have not been conducted with pivekimab sunirine-pvzy or the small molecule FGN849. Mutagene”
NegatedCarcinogenicity: “sunirine-pvzy. 13. 13.1 Carcinogenesis Carcinogenicity studies have not been conducted with pivekimab sunirine-pvzy or the small molecule FGN849. Mutagenesis FGN849 was”
Supporting onlyCarcinogenicity: “diagnosed or concurrently present hematologic malignancy at the time of BPDCN diagnosis The efficacy of DECNUPAZ in patients with treatment-naїve BPDCN was based on the rate of”
NegatedDevelopmental / embryo-fetal toxicity: “Data Animal Data Animal reproductive or developmental toxicity studies were not conducted with pivekimab sunirine-pvzy. The cytotoxic component of DECNUPAZ, FGN849, is a DNA-alkylati”
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.

DECNUPAZ (PIVEKIMAB SUNIRINE-PVZY): 5 of 6 NIOSH criteria in the label | Clariscope