Screening report

Bayer HealthCare Pharmaceuticals Inc. · Package insert of record

HYRNUO (SEVABERTINIB)

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
19 passages in the label

“…discontinue HYRNUO based on severity. ( 5.6 ) 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) ]. 5.7 Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, HYRNUO can cause fetal harm when administer…”

“…harm when administered to a pregnant woman. In embryo-fetal development studies, oral administration of sevabertinib to pregnant rats during the period of organogenesis resulted i…”

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

“…dose. Grade 4 Permanently discontinue HYRNUO. Hepatotoxicity [see Warnings and Precautions (5.2) ] Grade 2, 3 or 4 ALT and/or AST without increased total bilirubin or Grade 3 to…”

2 more passages

“…discontinue HYRNUO based on severity. ( 5.1 ) Hepatotoxicity : Monitor liver function tests including ALT, AST, and total bilirubin at baseline prior to the first administration…”

“…[see Dosage and Administration (2.3) ] . 5.2 Hepatotoxicity HYRNUO can cause severe hepatotoxicity characterized by elevations of liver function tests. In the pooled safety pop…”

Drug-class hint
Context only · not counted

“…with documented progression on HER2-targeted antibody drug conjugates (ADCs) (Group E, N=52). Among 191 patients who received HYRNUO, 66% were exposed for greater than 6 months and 43% wer…”

Set aside: found but not counted (6)
NegatedCarcinogenicity: “MRP2, OAT1, OAT3, OCT1, or OCT2. 13 13.1 Carcinogenesis Carcinogenicity studies have not been conducted with sevabertinib. Mutagenesis Sevabertinib was not genotoxic in a”
NegatedCarcinogenicity: “OAT3, OCT1, or OCT2. 13 13.1 Carcinogenesis Carcinogenicity studies have not been conducted with sevabertinib. Mutagenesis Sevabertinib was not genotoxic in a bacterial rever”
NegatedGenotoxicity / mutagenicity: “have not been conducted with sevabertinib. Mutagenesis Sevabertinib was not genotoxic in a bacterial reverse mutation (Ames) and an in vitro micronucleus assay, or an in”
NegatedGenotoxicity / mutagenicity: “sevabertinib. Mutagenesis Sevabertinib was not genotoxic in a bacterial reverse mutation (Ames) and an in vitro micronucleus assay, or an in vivo micronucleus assay in rats.”
NegatedGenotoxicity / mutagenicity: “reverse mutation (Ames) and an in vitro micronucleus assay, or an in vivo micronucleus assay in rats. Fertility studies have not been conducted with sevabertinib. 14 CLIN”
Supporting onlyGenotoxicity / mutagenicity: “an in vitro micronucleus assay, or an in vivo micronucleus assay in rats. Fertility studies have not been conducted with sevabertinib. 14 CLINICAL STUDIES 14.1 Locally Advanced”
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.