Screening report

Mirati Therapeutics, Inc · Package insert of record

KRAZATI (ADAGRASIB)

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
2 passages in the label

“…daily (see Data) . Data Animal Data In a rat embryo-fetal development study, once daily oral administration of adagrasib to pregnant rats during the period of organogenesis resu…”

1 more passage

Animal study“…surface area [BSA]). Adagrasib induced skeletal malformations, such as bent limbs, and skeletal variations, such as bent scapula, wavy ribs, and supernumerary short cervical ribs a…”

Reproductive / fertility toxicity
4 passages in the label

“…for 1 week after the last dose [see (8.2) ]. Infertility Inform patients that KRAZATI may cause infertility [see (8.3) ]. KRAZATI (adagrasib) Distributed by: Bristol-Myers Sq…”

2 more passages

“…Inform patients that KRAZATI may cause infertility [see (8.3) ]. KRAZATI (adagrasib) Distributed by: Bristol-Myers Squibb Company Princeton, NJ 08543 USA KRAZATI and th…”

Animal study“…on findings from animal studies, KRAZATI may impair fertility in females and males of reproductive potential [see (13.1) ] . 8.4 Pediatric Use The safety and effectiveness of KRAZ…”

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

“…arrhythmia • Permanently discontinue KRAZATI Hepatotoxicity [see Warnings and Precautions (5.3) ] Grade 2 AST or ALT • Decrease KRAZATI to the next lower dose level. Grade 3 or…”

2 more passages

“…discontinue based on severity. ( 2.3 , 5.2 ) • Hepatotoxicity: Monitor liver laboratory tests prior to the start of KRAZATI and monthly for 3 months after and as clinically indic…”

“…[see Dosage and Administration (2.3) ] . 5.3 Hepatotoxicity KRAZATI can cause hepatotoxicity, which may lead to drug-induced liver injury and hepatitis. In the pooled safety po…”

Drug-class hint
Context only · not counted

“…NSCLC who previously received treatment with a platinum-based regimen and an immune checkpoint inhibitor, an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or…”

Set aside: found but not counted (12)
NegatedCarcinogenicity: “and may inhibit MATE-1/MATE-2K. 13 13.1 Carcinogenicity studies have not been conducted with adagrasib. Adagrasib was not mutagenic in an in vitro bacterial reverse mutat”
NegatedGenotoxicity / mutagenicity: “conducted with adagrasib. Adagrasib was not mutagenic in an in vitro bacterial reverse mutation (Ames) assay and was not genotoxic in an in vitro chromosomal aberration as”
NegatedGenotoxicity / mutagenicity: “reverse mutation (Ames) assay and was not genotoxic in an in vitro chromosomal aberration assay or an in vivo micronucleus assay in rats. Fertility studies were not cond”
NegatedGenotoxicity / mutagenicity: “assay and was not genotoxic in an in vitro chromosomal aberration assay or an in vivo micronucleus assay in rats. Fertility studies were not conducted with adagrasib. In toxicology stud”
NegatedGenotoxicity / mutagenicity: “chromosomal aberration assay or an in vivo micronucleus assay in rats. Fertility studies were not conducted with adagrasib. In toxicology studies of up to 13-weeks in duration”
NegatedDevelopmental / embryo-fetal toxicity: “did not cause adverse development effects or embryo-fetal lethality at exposures below the human exposure at the recommended dose of 600 mg twice daily (see Data) . Data Anima”
NegatedDevelopmental / embryo-fetal toxicity: “developmental effects and did not affect embryo-fetal survival in rabbits at doses up to 30 mg/kg once daily. 8.2 Lactation Risk Summary There are no data on the presence of”
NegatedOrgan toxicity (verify at low doses): “causes • Permanently discontinue KRAZATI Interstitial Lung Disease / Pneumonitis [see Warnings and Precautions (5.4) ] Any Grade • Withhold KRAZATI if ILD/pneumonitis is suspected. • Per”
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.