TRUQAP (capivasertib): 3 of 6 NIOSH criteria in the label

Screening report

AstraZeneca Pharmaceuticals LP · Package insert of record

TRUQAP (capivasertib)

Not on the NIOSH ListDailyMed

Carcinogenic / genotoxic findings in the label

The label reports carcinogenicity and/or genotoxicity findings — among the criteria NIOSH uses to identify hazardous drugs.

3 / 6NIOSH hazard criteria present in this label

Special handling

Carcinogenicity

Developmental

Reproductive

Genotoxicity

Organ toxicity

Genotoxicity / mutagenicity

3 passages in the label

Animal data

“…in the tested rat strain. Capivasertib was genotoxic in the in vivo rat bone marrow micronucleus assay through an aneugenic mechanism. Capivasertib was not mutagenic in v…”

2 more passages

“…rat bone marrow micronucleus assay through an aneugenic mechanism. Capivasertib was not mutagenic in vitro in a bacterial reverse mutation (Ames) assay or mouse lymphoma gen…”

“…was genotoxic in the in vivo rat bone marrow micronucleus assay through an aneugenic mechanism. Capivasertib was not mutagenic in vitro in a bacterial reverse mutation (Ames) as…”

Developmental / embryo-fetal toxicity

17 passages in the label

“…TRUQAP based on severity. ( 2.5 , 5.3 ) • Embryo-Fetal Toxicity: TRUQAP can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.…”

2 more passages

“…25% (54/212) with systemic corticosteroids. 5.4 Embryo-Fetal Toxicity Based on findings from animals and mechanism of action, TRUQAP can cause fetal harm when administered to a pre…”

“…adverse developmental outcomes, including embryo-fetal mortality, and reduced fetal weights at maternal exposures 0.7 times the human exposure (AUC) at the recommended dosage…”

Reproductive / fertility toxicity

1 passage in the label

“…or abiraterone for contraception and infertility information. TRUQAP can cause fetal harm when administered to pregnant women [see (8.1) ] . Pregnancy Testing Verify…”

Set aside: found but not counted (2)

Supporting onlyCarcinogenicity: “MATE2-K, and OCT2. 13 13.1 In a 2-year rat carcinogenicity study, rats received oral doses up to 30 mg/kg/day in males and 75 mg/kg/day in females (approximately 0.2 times a”

NegatedGenotoxicity / mutagenicity: “an aneugenic mechanism. Capivasertib was not mutagenic in vitro in a bacterial reverse mutation (Ames) assay or mouse lymphoma gene mutation assay. In repeat-dose toxicity”

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.