RASONQUE (DARAXONRASIB): 2 of 6 NIOSH criteria in the label

Screening report

Revolution Medicines, Inc. · Package insert of record

RASONQUE (DARAXONRASIB)

Not on the NIOSH ListDailyMed

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

Carcinogenicity

Developmental

Reproductive

Genotoxicity

Organ toxicity

Developmental / embryo-fetal toxicity

15 passages in the label

“…ILD/pneumonitis are identified. ( 2.3 , 5.5 ) Embryo-Fetal Toxicity : RASONQUE can cause fetal harm. Advise of the potential risk to the fetus and to use effective contraception.…”

2 more passages

“…[see Dosage and Administration (2.3) ] . 5.6 Embryo-Fetal Toxicity Based on findings in animals, RASONQUE can cause fetal harm when administered to a pregnant woman. In an anima…”

“…[see Warnings and Precautions (5.5) ] . Embryo-Fetal Toxicity Advise females to inform their healthcare provider if they are pregnant or become pregnant. Inform females of…”

Organ toxicity (verify at low doses)

13 passages in the label

“…dose level. Grade 4 Permanently discontinue. Interstitial Lung Disease/Pneumonitis [see Warnings and Precautions (5.5) ] Grade 2 Withhold RASONQUE until recovery to ≤ Grade 1. If appropriate…”

2 more passages

“…perforation are identified. ( 2.3 , 5.4 ) Interstitial Lung Disease (ILD)/Pneumonitis : Monitor for new or worsening pulmonary symptoms. Withhold if suspected. If appropriate, reduce the…”

“…[see Dosage and Administration (2.3) ]. 5.5 Interstitial Lung Disease (ILD)/Pneumonitis RASONQUE can cause interstitial lung disease or pneumonitis. In clinical trials of patients with panc…”

Set aside: found but not counted (9)

NegatedCarcinogenicity: “pravastatin (an OATP1B3 substrate). 13 13.1 Carcinogenesis Carcinogenesis studies have not been conducted with daraxonrasib. Mutagenesis Daraxonrasib was not mutagenic in an”

NegatedCarcinogenicity: “OATP1B3 substrate). 13 13.1 Carcinogenesis Carcinogenesis studies have not been conducted with daraxonrasib. Mutagenesis Daraxonrasib was not mutagenic in an in vitro bacter”

NegatedGenotoxicity / mutagenicity: “have not been conducted with daraxonrasib. Mutagenesis Daraxonrasib was not mutagenic in an in vitro bacterial reverse mutation (Ames) assay, not clastogenic in an in vit”

NegatedGenotoxicity / mutagenicity: “daraxonrasib. Mutagenesis Daraxonrasib was not mutagenic in an in vitro bacterial reverse mutation (Ames) assay, not clastogenic in an in vitro micronucleus assay in human pe”

NegatedGenotoxicity / mutagenicity: “in human peripheral blood lymphocytes, and not genotoxic in an in vivo mouse bone marrow micronuclei test. No fertility studies have been conducted with daraxonrasib. In ge”

NegatedGenotoxicity / mutagenicity: “bacterial reverse mutation (Ames) assay, not clastogenic in an in vitro micronucleus assay in human peripheral blood lymphocytes, and not genotoxic in an in vivo mouse bone m”

NegatedGenotoxicity / mutagenicity: “(Ames) assay, not clastogenic in an in vitro micronucleus assay in human peripheral blood lymphocytes, and not genotoxic in an in vivo mouse bone marrow micronuclei test. No f”

NegatedOrgan toxicity (verify at low doses): “discontinue if no other potential causes of ILD/pneumonitis are identified. ( 2.3 , 5.5 ) Embryo-Fetal Toxicity : RASONQUE can cause fetal harm. Advise of the potential risk to th”

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.