Screening report

Corcept Therapeutics Incorporated · Package insert of record

Lifyorli (RELACORILANT)

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: present in the label
Genotoxicity: not found
Organ toxicity: not found
Developmental / embryo-fetal toxicity
22 passages in the label

“…for systemic glucocorticoids. ( 5.3 ) Embryo-Fetal Toxicity : LIFYORLI can cause fetal harm. Advise females of reproductive potential of the risk to a fetus and to use ef…”

2 more passages

“…purposes, [see Contraindications ( 4 )] . 5.4 Embryo-Fetal Toxicity Based on data from animal studies, LIFYORLI can cause fetal harm when administered to a pregnant woman. Oral a…”

“…in adverse developmental outcomes, including embryo-fetal mortality. Advise pregnant women of the potential risk to a fetus. Verify pregnancy status of females of reproductive p…”

Reproductive / fertility toxicity
1 passage in the label

“…of nab-paclitaxel for contraception and infertility information. LIFYORLI can cause fetal harm when administered to a pregnant woman [see ( 8.1 )] . Pregnancy Testing Ve…”

Drug-class hint
Context only · not counted

“…prior bevacizumab, 99.5% had received a prior taxane (19% in the last line of therapy and 4% in the platinum-resistant setting) and 61% had received a prior PARP inhibitor.…”

Set aside: found but not counted (10)
Supporting onlyManufacturer special-handling information: “is a glucocorticoid receptor antagonist antineoplastic agent. Relacorilant chemical names: (R)-(1-(4-fluorophenyl)-6-((1-methyl-1H-pyrazol-4-yl)sulfonyl)-4,4a,5,6,7,8-hexahyd”
NegatedCarcinogenicity: “There was no evidence of relacorilant-induced carcinogenicity in either study. Mutagenesis Relacorilant was not genotoxic in the bacterial reverse mutation (Ames) assay, an in”
Supporting onlyCarcinogenicity: “CORT125295 are inhibitors of BCRP. 13 13.1 Carcinogenesis In a 6-month carcinogenicity study, transgenic rasH2 mice were orally administered up to 100 mg/kg/day relacorilant”
NegatedGenotoxicity / mutagenicity: “carcinogenicity in either study. Mutagenesis Relacorilant was not genotoxic in the bacterial reverse mutation (Ames) assay, an in vitro human lymphocyte micronu”
NegatedGenotoxicity / mutagenicity: “either study. Mutagenesis Relacorilant was not genotoxic in the bacterial reverse mutation (Ames) assay, an in vitro human lymphocyte micronucleus assay, or an in vivo micron”
NegatedGenotoxicity / mutagenicity: “(Ames) assay, an in vitro human lymphocyte micronucleus assay, or an in vivo micronucleus assay in rats. In a fertility study, relacorilant was administered orally to male r”
NegatedGenotoxicity / mutagenicity: “lymphocyte micronucleus assay, or an in vivo micronucleus assay in rats. In a fertility study, relacorilant was administered orally to male rats prior to and throughout mating”
NegatedDevelopmental / embryo-fetal toxicity: “the period of organogenesis did not result in fetal malformations [see Data ] . Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Data 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.