Screening report

Boehringer Ingelheim Pharmaceuticals, Inc. · Package insert of record

HERNEXEOS (ZONGERTINIB)

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.
3 / 6NIOSH hazard criteria present in this label
Special handling: not found
Carcinogenicity: not found
Developmental: present in the label
Reproductive: present in the label
Genotoxicity: not found
Organ toxicity: present in the label
Developmental / embryo-fetal toxicity
16 passages in the label

“…HERNEXEOS based on severity. ( 5.3 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. (…”

2 more passages

“…[see Dosage and Administration (2.3) ]. 5.4 Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, HERNEXEOS can cause fetal harm when adminis…”

“…risk to a fetus. Data Animal Data In an embryo-fetal development study, pregnant rats received oral doses of 10, 30, or 60 mg/kg/day of zongertinib during the period of org…”

Reproductive / fertility toxicity
5 passages in the label

“…of reproductive potential that HERNEXEOS may impair fertility [see (8.3) ] . Administration Instructions Instruct patients weighing less than 90 kg to take two 60 mg tablets once…”

2 more passages

“…2 weeks after the last dose [see (8.2) ] . Infertility Advise females and males of reproductive potential that HERNEXEOS may impair fertility [see (8.3) ] . Administration…”

Animal study“…on findings from animal studies, HERNEXEOS may impair fertility in females. The effects in female animals were reversible [see (13.1) ] . Males Based on findings from animal studies…”

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

“…Criteria for Adverse Events (CTCAE) version 5.0 Hepatotoxicity [see Warnings and Precautions (5.1) ] Grade 3 or 4 ALT and/or AST without increased total bilirubin Interrupt HERNEX…”

2 more passages

“…None. None. ( 4 ) 5 WARNINGS AND PRECAUTIONS Hepatotoxicity : Monitor liver function tests including ALT, AST, and total bilirubin at baseline prior to administration, every 2…”

“…and to use effective contraception. ( 5.4 ) 5.1 Hepatotoxicity HERNEXEOS can cause severe and life-threatening hepatotoxicity, including drug induced liver injury. In the pooled s…”

Drug-class hint
Context only · not counted

“…kinase inhibitor (TKI) or HER2-targeted antibody-drug conjugate (ADC). Efficacy results are summarized in Table 6. Table 6 Efficacy Results for Beamion LUNG-1 in Previously Treated No…”

Set aside: found but not counted (7)
NegatedCarcinogenicity: “(a sensitive CYP2C8 substrate). 13 13.1 Carcinogenesis Carcinogenicity studies have not been conducted with zongertinib. Mutagenesis Zongertinib was not mutagenic in an i”
NegatedCarcinogenicity: “CYP2C8 substrate). 13 13.1 Carcinogenesis Carcinogenicity studies have not been conducted with zongertinib. Mutagenesis Zongertinib was not mutagenic in an in vitro bacteri”
NegatedGenotoxicity / mutagenicity: “have not been conducted with zongertinib. Mutagenesis Zongertinib was not mutagenic in an in vitro bacterial reverse mutation (Ames) assay. Zongertinib was not genotoxic”
NegatedGenotoxicity / mutagenicity: “zongertinib. Mutagenesis Zongertinib was not mutagenic in an in vitro bacterial reverse mutation (Ames) assay. Zongertinib was not genotoxic in an in vivo rat bone marrow m”
NegatedGenotoxicity / mutagenicity: “mutation (Ames) assay. Zongertinib was not genotoxic in an in vivo rat bone marrow micronucleus test and did not induce DNA breaks in a comet assay in liver or duodenum.”
NegatedGenotoxicity / mutagenicity: “was not genotoxic in an in vivo rat bone marrow micronucleus test and did not induce DNA breaks in a comet assay in liver or duodenum. Dedicated animal fertility studies have not”
NegatedDevelopmental / embryo-fetal toxicity: “study in rabbits, there were no adverse embryo-fetal findings in pregnant animals administered oral doses of zongertinib up to 120 mg/kg/day (2.4 times the human exposure b”
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.