Screening report

Eli Lilly and Company · Package insert of record

Verzenio (abemaciclib)

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
19 passages in the label

“…rats during the period of organogenesis caused teratogenicity and decreased fetal weight at maternal exposures that were similar to the human clinical exposure based on area un…”

2 more passages

“…of abemaciclib during organogenesis was teratogenic and caused decreased fetal weight at maternal exposures that were similar to human clinical exposure based on AUC at…”

“…treat as medically appropriate. ( 2.2 , 5.5 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. ( 5.6…”

Reproductive / fertility toxicity
6 passages in the label

“…bone marrow micronucleus assay. Abemaciclib may impair fertility in males of reproductive potential. In repeat-dose toxicity studies up to 3-months duration, abemaciclib-related findin…”

2 more passages

“…of reproductive potential that VERZENIO may impair fertility [see ( 8.3 )] . Drug Interactions Inform patients to avoid concomitant use of ketoconazole. Dose reduction may be req…”

“…combination with VERZENIO for contraception and infertility information. When used in combination, advise patients to use effective contraception during treatment and for the long…”

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

“…VERZENIO Dosage Modifications and Management — Hepatotoxicity Abbreviations: ALT = alanine aminotransferase, AST = aspartate aminotransferase, ULN = upper limit of normal. Monito…”

2 more passages

“…a a Excluding diarrhea, hematologic toxicity, hepatotoxicity, ILD/pneumonitis, and VTEs. CTCAE Grade VERZENIO Dosage Modifications Grade 1 or 2 No dosage modification is require…”

“…Grade 3 or 4 ILD or pneumonitis. ( 2.2 , 5.3 ) Hepatotoxicity: Increases in serum transaminase levels have been observed. Perform liver function tests (LFTs) before initiating tr…”

Drug-class hint
Context only · not counted

“…or after endocrine therapy, had received a taxane in any setting, and who received 1 or 2 prior chemotherapy regimens in the metastatic setting. Patients received VERZEN…”

Set aside: found but not counted (7)
NegatedCarcinogenicity: “in a 2-year rat study. Abemaciclib was not carcinogenic in male and female rats at oral doses up to 3 mg/kg/day (approximately 1 time the exposure at the maximum recommended”
Supporting onlyCarcinogenicity: “13 13.1 Abemaciclib was assessed for carcinogenicity in a 2-year rat study. Abemaciclib was not carcinogenic in male and female rats at oral doses up to 3 mg/kg/day (a”
NegatedGenotoxicity / mutagenicity: “active human metabolites M2 and M20 were not mutagenic in a bacterial reverse mutation (Ames) assay or clastogenic in an in vitro chromosomal aberration assay in Chinese ha”
NegatedGenotoxicity / mutagenicity: “in a bacterial reverse mutation (Ames) assay or clastogenic in an in vitro chromosomal aberration assay in Chinese hamster ovary cells or human peripheral blood lymphocytes. Abe”
NegatedGenotoxicity / mutagenicity: “lymphocytes. Abemaciclib, M2, and M20 were not clastogenic in an in vivo rat bone marrow micronucleus assay. Abemaciclib may impair fertility in males of reproductive potential”
NegatedGenotoxicity / mutagenicity: “(Ames) assay or clastogenic in an in vitro chromosomal aberration assay in Chinese hamster ovary cells or human peripheral blood lymphocytes. Abemaciclib, M2, and M20 were not clastogen”
NegatedGenotoxicity / mutagenicity: “not clastogenic in an in vivo rat bone marrow micronucleus assay. Abemaciclib may impair fertility in males of reproductive potential. In repeat-dose toxicity studies up to 3-mon”
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.