Screening report

Rigel Pharmaceuticals, Inc. · Package insert of record

VEPPANU (VEPDEGESTRANT)

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
19 passages in the label

“…discontinue VEPPANU based on severity. ( 5.1 ) Embryo-Fetal Toxicity : VEPPANU can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contrace…”

2 more passages

“…[see Dosage and Administration ( 2.3 )] . 5.2 Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, VEPPANU can cause fetal harm when administe…”

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

2 more passages

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

Animal study“…on findings from animal studies, VEPPANU may impair fertility in females and males of reproductive potential. The effects of vepdegestrant on fertility were reversible in female ani…”

Set aside: found but not counted (8)
NegatedCarcinogenicity: “OAT3, OATP1B1, OATP1B3, or OCT2. 13 13.1 Carcinogenesis Vepdegestrant was not carcinogenic in a 6-month carcinogenicity study in rasH2 transgenic mice with daily oral admi”
NegatedCarcinogenicity: “13.1 Carcinogenesis Vepdegestrant was not carcinogenic in a 6-month carcinogenicity study in rasH2 transgenic mice with daily oral administration of vepdegestrant up to 800”
NegatedCarcinogenicity: “Vepdegestrant was not carcinogenic in a 6-month carcinogenicity study in rasH2 transgenic mice with daily oral administration of vepdegestrant up to 800 mg/kg/day. Mutagenesis Ve”
NegatedGenotoxicity / mutagenicity: “of vepdegestrant up to 800 mg/kg/day. Mutagenesis Vepdegestrant was not mutagenic in an in vitro bacterial reverse mutation assay (Ames) or clastogenic in an in vitr”
NegatedGenotoxicity / mutagenicity: “mg/kg/day. Mutagenesis Vepdegestrant was not mutagenic in an in vitro bacterial reverse mutation assay (Ames) or clastogenic in an in vitro human lymphocyte micronucleus as”
NegatedGenotoxicity / mutagenicity: “bacterial reverse mutation assay (Ames) or clastogenic in an in vitro human lymphocyte micronucleus assay or an in vivo rat micronucleus assay. Fertility studies with vep”
NegatedGenotoxicity / mutagenicity: “or clastogenic in an in vitro human lymphocyte micronucleus assay or an in vivo rat micronucleus assay. Fertility studies with vepdegestrant in animals have not been conducted.”
NegatedGenotoxicity / mutagenicity: “lymphocyte micronucleus assay or an in vivo rat micronucleus assay. Fertility studies with vepdegestrant in animals have not been conducted. In repeat-dose toxicity studies up to”
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.