Screening report

Servier Pharmaceuticals LLC · Package insert of record

VORANIGO (vorasidenib)

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
28 passages in the label

“…VORANIGO based on severity. ( 2.3 , 5.1 ) Embryo-Fetal Toxicity : VORANIGO can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective nonhorm…”

2 more passages

“…(2.3) and Adverse Reactions (6.1) ]. 5.2 Embryo-Fetal Toxicity Based on findings from animal studies, VORANIGO can cause fetal harm when administered to a pregnant woman. In…”

“…administered to a pregnant woman. In animal embryo-fetal development studies, oral administration of vorasidenib to pregnant rats during the period of organogenesis caused embr…”

Reproductive / fertility toxicity
6 passages in the label

“…not to breastfeed. ( 8.2 ) Infertility : May impair fertility in males and females. ( 8.3 ) 8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of act…”

2 more passages

“…of reproductive potential that VORANIGO may impair fertility [see (8.3) and (13.1) ]. Drug Interactions Advise patients and caregivers to inform their healthcare provider of al…”

“…Lactation : Advise not to breastfeed. ( 8.2 ) Infertility : May impair fertility in males and females. ( 8.3 ) 8.1 Pregnancy Risk Summary Based on findings from animal studies a…”

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

“…aminotransferase; ULN = Upper limit of normal Hepatotoxicity (Elevation of ALT or AST) [see Warnings and Precautions (5.1) ] Grade 1 ALT or AST increase >ULN to 3 × ULN without…”

2 more passages

“…None. None. ( 4 ) 5 WARNINGS AND PRECAUTIONS Hepatotoxicity : VORANIGO can cause hepatic transaminase elevations, which can lead to hepatic failure, hepatic necrosis, and autoi…”

“…contraception. ( 5.2 , 8.1 , 8.3 ) 5.1 Hepatotoxicity VORANIGO can cause hepatic transaminase elevations, which can lead to hepatic failure, hepatic necrosis, and autoimm…”

Set aside: found but not counted (6)
NegatedCarcinogenicity: “does not inhibit P-gp and OATP1B1. 13 13.1 Carcinogenicity studies have not been conducted with vorasidenib. Vorasidenib and its major circulating metabolite, AGI-69460, wer”
NegatedGenotoxicity / mutagenicity: “circulating metabolite, AGI-69460, were not mutagenic in an in vitro bacterial reverse mutation (Ames) assay. Vorasidenib and AGI-69460 were not clastogenic in an in vitro”
NegatedGenotoxicity / mutagenicity: “assay. Vorasidenib and AGI-69460 were not clastogenic in an in vitro human lymphocyte micronucleus assay, or an in vivo rat bone marrow micronucleus assay. AGI-69460 did n”
NegatedGenotoxicity / mutagenicity: “not clastogenic in an in vitro human lymphocyte micronucleus assay, or an in vivo rat bone marrow micronucleus assay. AGI-69460 did not induce DNA damage in rat liver in the in viv”
NegatedGenotoxicity / mutagenicity: “micronucleus assay. AGI-69460 did not induce DNA damage in rat liver in the in vivo comet assay. Fertility studies in animals have not been conducted with vorasidenib. In repe”
Supporting onlyGenotoxicity / mutagenicity: “assay, or an in vivo rat bone marrow micronucleus assay. AGI-69460 did not induce DNA damage in rat liver in the in vivo comet assay. Fertility studies in animals have n”
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.