Screening report

Jazz Pharmaceuticals, Inc. · Package insert of record

MODEYSO (DORDAVIPRONE)

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

“…life-threatening arrhythmias. ( 5.2 , 12.2 ) • Embryo-fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. (…”

2 more passages

“…[see Dosage and Administration ( 2.4 )] . 5.3 Embryo-fetal Toxicity Based on findings from animal studies and its mechanism of action, MODEYSO can cause fetal harm when administe…”

“…harm when administered to a pregnant woman. In embryo-fetal development studies, oral administration of dordaviprone to pregnant rats and rabbits during organogenesis caused embry…”

Reproductive / fertility toxicity
1 passage in the label

“…MODEYSO and for 1 month after the last dose. Infertility Based on the mechanism of action of dordaviprone (dopamine D2 receptor inhibition and alterations to mitochondrial func…”

Set aside: found but not counted (6)
NegatedCarcinogenicity: “OAT3, OATP1B1, OATP1B3, and OCT1. 13 13.1 Carcinogenesis Carcinogenicity studies with dordaviprone were not conducted. Mutagenesis Dordaviprone was not genotoxic in in vitr”
NegatedCarcinogenicity: “OATP1B3, and OCT1. 13 13.1 Carcinogenesis Carcinogenicity studies with dordaviprone were not conducted. Mutagenesis Dordaviprone was not genotoxic in in vitro (Ames and mic”
NegatedGenotoxicity / mutagenicity: “studies with dordaviprone were not conducted. Mutagenesis Dordaviprone was not genotoxic in in vitro (Ames and micronucleus assay) and in vivo (mouse micronucleus) assays.”
NegatedGenotoxicity / mutagenicity: “not conducted. Mutagenesis Dordaviprone was not genotoxic in in vitro (Ames and micronucleus assay) and in vivo (mouse micronucleus) assays. Dedicated fertility studies were”
NegatedGenotoxicity / mutagenicity: “was not genotoxic in in vitro (Ames and micronucleus assay) and in vivo (mouse micronucleus) assays. Dedicated fertility studies were not conducted with dordaviprone. 13.”
NegatedGenotoxicity / mutagenicity: “and micronucleus assay) and in vivo (mouse micronucleus) assays. Dedicated fertility studies were not conducted with dordaviprone. 13.2 Animal Toxicology and/or Pharmacology”
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.