Screening report

BeOne Medicines USA, Inc. · Package insert of record

BRUKINSA (zanubrutinib)

Not on the NIOSH ListDailyMed (opens the full label on DailyMed in a new tab)
Carcinogenic / genotoxic findings in the label
The label reports carcinogenicity and/or genotoxicity findings — among the criteria NIOSH uses to identify hazardous drugs.
4 / 6NIOSH hazard criteria present in this label
Special handling: not found
Carcinogenicity: present in the label
Developmental: present in the label
Reproductive: not found
Genotoxicity: present in the label
Organ toxicity: present in the label
Carcinogenicity
37 passages in the label

“…growth factor or transfusions, as needed. 5.4 Second Primary Malignancies Second primary malignancies, including non-skin carcinoma, have occurred in 14% of patients treated with BRUKINSA.…”

2 more passages

“…as needed. 5.4 Second Primary Malignancies Second primary malignancies, including non-skin carcinoma, have occurred in 14% of patients treated with BRUKINSA. The most frequent second pri…”

“…≥5% of patients were COVID-19, pneumonia, and second primary malignancy (5% each). Fatal adverse reactions occurred in 11 (4.6%) patients with the leading cause of death being COVID-19 (2.1…”

Genotoxicity / mutagenicity
2 passages in the label
Animal data

“…assay in mammalian (CHO) cells, nor was it clastogenic in an in vivo bone marrow micronucleus assay in rats. A combined male and female fertility and early embryonic develo…”

1 more passage

“…was it clastogenic in an in vivo bone marrow micronucleus assay in rats. A combined male and female fertility and early embryonic development study was conducted in rats at oral…”

Developmental / embryo-fetal toxicity
20 passages in the label

“…hepatic function throughout treatment. ( 5.6 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise women of the potential risk to a fetus and to use effective contraception. ( 5.…”

2 more passages

“…confirmation of DILI, discontinue BRUKINSA. 5.7 Embryo-Fetal Toxicity Based on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administrat…”

“…rats during the period of organogenesis caused embryo-fetal toxicity, including malformations at exposures that were 5 times higher than those reported in patients at the recommen…”

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

“…arrhythmias and manage appropriately. ( 5.5 ) Hepatotoxicity, Including Drug-Induced Liver Injury : Monitor hepatic function throughout treatment. ( 5.6 ) Embryo-Fetal Toxicity…”

2 more passages

“…benefits of continued BRUKINSA treatment. 5.6 Hepatotoxicity, Including Drug-Induced Liver Injury Hepatotoxicity, including severe, life-threatening, and potentially fatal cases…”

“…Including Drug-Induced Liver Injury Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred i…”

Drug-class hint
Context only · not counted

“…disease with 85% having received prior alkylating agents and 91% prior anti-CD20 therapy. The median number of prior therapies in those with relapsed/refractory disease was 1…”

Set aside: found but not counted (7)
NegatedCarcinogenicity: “OAT3, OCT2, OATP1B1, or OATP1B3. 13 13.1 Carcinogenicity studies have not been conducted with zanubrutinib. Zanubrutinib was not mutagenic in a bacterial mutagenicity (Ame”
NegatedGenotoxicity / mutagenicity: “with zanubrutinib. Zanubrutinib was not mutagenic in a bacterial mutagenicity (Ames) assay, was not clastogenic in a chromosome aberration assay in mammalian (CHO) cel”
NegatedGenotoxicity / mutagenicity: “Zanubrutinib was not mutagenic in a bacterial mutagenicity (Ames) assay, was not clastogenic in a chromosome aberration assay in mammalian (CHO) cells, nor was it clastogeni”
NegatedGenotoxicity / mutagenicity: “a bacterial mutagenicity (Ames) assay, was not clastogenic in a chromosome aberration assay in mammalian (CHO) cells, nor was it clastogenic in an in vivo bone marrow micronucl”
NegatedGenotoxicity / mutagenicity: “(Ames) assay, was not clastogenic in a chromosome aberration assay in mammalian (CHO) cells, nor was it clastogenic in an in vivo bone marrow micronucleus assay in rats. A combined”
NegatedDevelopmental / embryo-fetal toxicity: “to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of zanubrutin”
NegatedDevelopmental / embryo-fetal toxicity: “at doses of 30, 75, and 150 mg/kg/day. Malformations in the heart (2 or 3-chambered hearts) were noted at all dose levels in the absence of maternal toxicity. The dose of”
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.