Inluriyo (imlunestrant): 4 of 6 NIOSH criteria in the label

Screening report

Eli Lilly and Company · Package insert of record

Inluriyo (imlunestrant)

Not on the NIOSH ListDailyMed

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

Carcinogenicity

Developmental

Reproductive

Genotoxicity

Organ toxicity

Genotoxicity / mutagenicity

2 passages in the label

“…reverse mutation (Ames) assay. Imlunestrant was clastogenic in an in vitro human lymphocyte micronucleus assay. Imlunestrant was not genotoxic in an in vivo rat bone marrow micr…”

1 more passage

“…was clastogenic in an in vitro human lymphocyte micronucleus assay. Imlunestrant was not genotoxic in an in vivo rat bone marrow micronucleus test and did not induce DNA breaks in…”

Developmental / embryo-fetal toxicity

20 passages in the label

“…None. None. ( 4 ) 5 WARNINGS AND PRECAUTIONS Embryo-Fetal Toxicity: INLURIYO can cause fetal harm. Advise of the potential risk to a fetus and to use effective contraception. (…”

2 more passages

“…contraception. ( 5.1 , 8.1 , 8.3 ) 5.1 Embryo-Fetal Toxicity Based on findings in animals and its mechanism of action, INLURIYO can cause fetal harm when administered to a…”

“…rats during the period of organogenesis led to embryo-fetal mortality and structural abnormalities at maternal exposures that were below the human exposure at the recommended dose…”

Reproductive / fertility toxicity

5 passages in the label

“…of reproductive potential that INLURIYO may impair fertility [see ( 8.3 )] . Drug Interactions Advise patients to inform their healthcare providers of all concomitant medications…”

2 more passages

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

“…Information of the individual products. Infertility Advise males and females of reproductive potential that INLURIYO may impair fertility [see ( 8.3 )] . Drug Interactio…”

Organ toxicity (verify at low doses)

2 passages in the label

“…Modifications - Adverse Reactions (except hepatotoxicity) Grade INLURIYO Dosage Modifications Persistent or recurrent Grade 2 that does not resolve with maximal supportive m…”

1 more passage

“…dose. Table 2: INLURIYO Dosage Modification - Hepatotoxicity Abbreviation: ALT = alanine aminotransferase, AST = aspartate aminotransferase, TBL=total bilirubin, ULN = upper lim…”

Set aside: found but not counted (6)

NegatedCarcinogenicity: “of BCRP, OCT1, OATP1B1, or OATP1B3. 13 13.1 Carcinogenesis Carcinogenicity studies have not been conducted with imlunestrant. Mutagenesis Imlunestrant was not mutagenic in th”

NegatedCarcinogenicity: “OATP1B1, or OATP1B3. 13 13.1 Carcinogenesis Carcinogenicity studies have not been conducted with imlunestrant. Mutagenesis Imlunestrant was not mutagenic in the bacterial rev”

NegatedGenotoxicity / mutagenicity: “have not been conducted with imlunestrant. Mutagenesis Imlunestrant was not mutagenic in the bacterial reverse mutation (Ames) assay. Imlunestrant was clastogenic in an i”

NegatedGenotoxicity / mutagenicity: “imlunestrant. Mutagenesis Imlunestrant was not mutagenic in the bacterial reverse mutation (Ames) assay. Imlunestrant was clastogenic in an in vitro human lymphocyte micronuc”

NegatedGenotoxicity / mutagenicity: “micronucleus assay. Imlunestrant was not genotoxic in an in vivo rat bone marrow micronucleus test and did not induce DNA breaks in the liver and duodenum comet assays.”

NegatedGenotoxicity / mutagenicity: “was not genotoxic in an in vivo rat bone marrow micronucleus test and did not induce DNA breaks in the liver and duodenum comet assays. Fertility studies with imlunestrant in ani”

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.