Screening report

Partner Therapeutics, Inc. · Package insert of record

BIZENGRI (ZENOCUTUZUMAB)

Not on the NIOSH ListDailyMed (opens the full label on DailyMed in a new tab)
Developmental / reproductive language
The label notes developmental and/or reproductive toxicity. Many drugs carry this language and are not classified as hazardous.
2 / 6NIOSH hazard criteria present in this label
Special handling: not found
Carcinogenicity: not found
Developmental: present in the label
Reproductive: not found
Genotoxicity: not found
Organ toxicity: present in the label
Developmental / embryo-fetal toxicity
28 passages in the label

“…dihydrate polysorbate 20 water WARNING: EMBRYO-FETAL TOXICITY Embryo-Fetal Toxicity: Exposure to BIZENGRI during pregnancy can cause embryo-fetal harm. Advise patients of t…”

2 more passages

“…20 water WARNING: EMBRYO-FETAL TOXICITY Embryo-Fetal Toxicity: Exposure to BIZENGRI during pregnancy can cause embryo-fetal harm. Advise patients of this risk and the need…”

“…Exposure to BIZENGRI during pregnancy can cause embryo-fetal harm. Advise patients of this risk and the need for effective contraception [see Warnings and Precautions (5.4) , (8.…”

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

“…reaction Permanently discontinue BIZENGRI. Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions (5.2) ] Grade 1 Interrupt BIZENGRI until recovery. Consider prompt init…”

2 more passages

“…IRR or hypersensitivity/anaphylaxis. ( 5.1 ) Interstitial Lung Disease (ILD)/Pneumonitis : Monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis. Permanently disconti…”

“…or hypersensitivity/anaphylaxis reactions. 5.2 Interstitial Lung Disease/Pneumonitis BIZENGRI can cause serious and life-threatening interstitial lung disease (ILD)/pneumonitis. In the eNRGy s…”

Drug-class hint
Context only · not counted

“…systemic therapy with FOLFIRINOX, gemcitabine/taxane-based therapy, or both. A total of 27 patients (90%) had an NRG1 gene fusion detected by RNA-based NGS that may include…”

Set aside: found but not counted (5)
Supporting onlyManufacturer special-handling information: “mediates antibody-dependent cellular cytotoxicity (ADCC). Zenocutuzumab-zbco showed antitumor activity in mouse models of NRG1 fusion-positive lung and pancreatic can”
NegatedCarcinogenicity: “No studies have been performed to assess the carcinogenic or mutagenic potential of zenocutuzumab-zbco. Animal fertility studies have not been conducted with zenocutuzumab-zbc”
Supporting onlyCarcinogenicity: “blood creatinine increased, back pain, myelodysplastic syndrome, and respiratory disorder. There were 2 fatal adverse reactions, one due to COVID-19 and one due to respiratory failure”
NegatedGenotoxicity / mutagenicity: “been performed to assess the carcinogenic or mutagenic potential of zenocutuzumab-zbco. Animal fertility studies have not been conducted with zenocutuzumab-zbco. 14 CLINICA”
NegatedDevelopmental / embryo-fetal toxicity: “Data There were no animal reproductive or developmental toxicity studies conducted with zenocutuzumab-zbco. A literature-based assessment of the effects on reproduction demonstrated th”
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.