Screening report

Amgen Inc · Package insert of record

LUMAKRAS (SOTORASIB)

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
1 passage in the label

“…with panitumumab. Data Animal Data In a rat embryo-fetal development study, once daily oral administration of sotorasib to pregnant rats during the period of organogenesis resu…”

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

“…aminotransferase; ULN = upper limit of normal Hepatotoxicity [see Warnings and Precautions (5.1) ] AST or ALT > 3 × and up to 5 × ULN (or > 3 × and up to 5 × baseline if baselin…”

2 more passages

“…None. None. ( 4 ) 5 WARNINGS AND PRECAUTIONS Hepatotoxicity: Monitor liver function tests every 3 weeks for the first 3 months of treatment then once monthly as clinically indi…”

“…are identified. ( 2.3 , 5.2 ) 5.1 Hepatotoxicity LUMAKRAS can cause hepatotoxicity and increased alanine aminotransferase (ALT) or increased aspartate aminotransfera…”

Drug-class hint
Context only · not counted

“…receiving an immune checkpoint inhibitor and/or platinum-based chemotherapy, an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1, and at least one measurable…”

Set aside: found but not counted (12)
NegatedCarcinogenicity: “CYP2C8, CYP2C9, CYP2C19, or CYP2D6. 13 13.1 Carcinogenicity studies have not been performed with sotorasib. Sotorasib was not mutagenic in an in vitro bacterial reverse mutat”
Supporting onlyCarcinogenicity: “of KRAS G12C, a tumor-restricted, mutant-oncogenic form of the RAS GTPase, KRAS. Sotorasib forms an irreversible, covalent bond with the unique cysteine of KRAS G12C, loc”
NegatedGenotoxicity / mutagenicity: “performed with sotorasib. Sotorasib was not mutagenic in an in vitro bacterial reverse mutation (Ames) assay and was not genotoxic in the in vivo rat micronucleus and come”
NegatedGenotoxicity / mutagenicity: “reverse mutation (Ames) assay and was not genotoxic in the in vivo rat micronucleus and comet assays. Fertility/early embryonic development studies were not conducted wi”
NegatedGenotoxicity / mutagenicity: “assay and was not genotoxic in the in vivo rat micronucleus and comet assays. Fertility/early embryonic development studies were not conducted with sotorasib. There were no advers”
NegatedDevelopmental / embryo-fetal toxicity: “use in pregnant women. In rat and rabbit embryo-fetal development studies, oral sotorasib did not cause adverse developmental effects or embryo-lethality at exposures up to”
NegatedDevelopmental / embryo-fetal toxicity: “developmental effects and did not affect embryo-fetal survival at doses up to 540 mg/kg. In a rabbit embryo-fetal development study, once daily oral administration of sotora”
NegatedDevelopmental / embryo-fetal toxicity: “developmental effects and did not affect embryo-fetal survival at doses up to 100 mg/kg. 8.2 Lactation Risk Summary There are no data on the presence of sotorasib or its met”
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.