Screening report

Rigel Pharmaceuticals, Inc. · Package insert of record

REZLIDHIA (OLUTASIDENIB)

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

“…) 8.1 Pregnancy Risk Summary Based on animal embryo-fetal toxicity studies, REZLIDHIA may cause fetal harm when administered to a pregnant woman. There are no available data on…”

2 more passages

“…to evaluate for a drug-associated risk. In embryo-fetal development studies, oral olutasidenib resulted in embryo-fetal death and altered fetal growth when administered to pre…”

“…studies, oral olutasidenib resulted in embryo-fetal death and altered fetal growth when administered to pregnant rats and rabbits during the period of organogenesis at exp…”

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

“…for Adverse Events (NCI CTCAE version 4.03). hepatotoxicity [see Warnings and Precautions ( 5.2 )] Withhold REZLIDHIA and monitor liver function tests, twice per week, until la…”

2 more passages

“…may increase to 150 mg twice daily if hepatotoxicity resolves to baseline for at least 28 days. If hepatotoxicity (Grade 3) recurs at 150 mg once daily, discontinue REZL…”

“…resolves to baseline for at least 28 days. If hepatotoxicity (Grade 3) recurs at 150 mg once daily, discontinue REZLIDHIA. Grade 4 hepatotoxicity or AST or ALT >3x ULN and total…”

Set aside: found but not counted (6)
NegatedCarcinogenicity: “BSEP, MRP2, MRP3, MRP4, or OAT1. 13 13.1 Carcinogenicity studies have not been conducted with olutasidenib. Olutasidenib was not genotoxic in the in vitro bacterial revers”
Supporting onlyCarcinogenicity: “msec) in 33 patients with advanced hematologic malignancies with an IDH1 mutation following a single dose and multiple doses of the approved recommended olutasidenib dosage under”
NegatedGenotoxicity / mutagenicity: “with olutasidenib. Olutasidenib was not genotoxic in the in vitro bacterial reverse mutation (Ames), in vitro human lymphocyte micronucleus, and in vivo rat bone marro”
NegatedGenotoxicity / mutagenicity: “mutation (Ames), in vitro human lymphocyte micronucleus, and in vivo rat bone marrow micronucleus assays. Fertility studies in animals have not been conducted with olutasideni”
NegatedGenotoxicity / mutagenicity: “micronucleus, and in vivo rat bone marrow micronucleus assays. Fertility studies in animals have not been conducted with olutasidenib. 13.2 Animal Toxicology and/or Pharmacol”
NegatedOrgan toxicity (verify at low doses): “mg once daily, discontinue REZLIDHIA. Grade 4 hepatotoxicity or AST or ALT >3x ULN and total bilirubin >2x ULN and alkaline phosphatase <2x ULN in the absence of a clear alterna”
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.