Screening report

Stemline Therapeutics, Inc. · Package insert of record

ORSERDU (ELACESTRANT)

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
20 passages in the label

“…treatment and periodically thereafter. ( 5.1 ) Embryo-Fetal Toxicity : ORSERDU can cause fetal harm. Advise of the potential risk to a fetus and to use effective contraception. (…”

2 more passages

“…and periodically while taking ORSERDU. 5.2 Embryo-Fetal Toxicity Based on findings in animals and its mechanism of action, ORSERDU can cause fetal harm when administered to a…”

“…in adverse developmental outcomes, including embryo-fetal mortality and structural abnormalities, at maternal exposures below the recommended dose based on area under the curve…”

Reproductive / fertility toxicity
4 passages in the label

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

2 more passages

“…1 week after the last dose [see ( 8.2 )] . Infertility Advise males and females of reproductive potential that ORSERDU may impair fertility [see ( 8.3 )] . Drug Interaction…”

Animal study“…on findings from animal studies, ORSERDU may impair fertility in females and males of reproductive potential [see ( 13.1 )] . 8.4 Pediatric Use The safety and effectiveness of ORS…”

Set aside: found but not counted (5)
NegatedCarcinogenicity: “OCT1, OATP1B1, OATP1B3 or OATP2B1. 13 13.1 Carcinogenicity studies have not been conducted with elacestrant. Elacestrant was not mutagenic in an in vitro bacterial reverse m”
NegatedGenotoxicity / mutagenicity: “conducted with elacestrant. Elacestrant was not mutagenic in an in vitro bacterial reverse mutation (Ames) assay or clastogenic in either in vitro chromosome aberration assays”
NegatedGenotoxicity / mutagenicity: “bacterial reverse mutation (Ames) assay or clastogenic in either in vitro chromosome aberration assays or an in vivo rat bone marrow micronucleus assay. Fertility studies w”
NegatedGenotoxicity / mutagenicity: “(Ames) assay or clastogenic in either in vitro chromosome aberration assays or an in vivo rat bone marrow micronucleus assay. Fertility studies with elacestrant in animals have not been co”
NegatedGenotoxicity / mutagenicity: “aberration assays or an in vivo rat bone marrow micronucleus assay. Fertility studies with elacestrant in animals have not been conducted. In repeated-dose toxicity studies up to 2”
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.