Screening report

SEAGEN INC. · Package insert of record

TUKYSA (tucatinib)

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
17 passages in the label

“…TUKYSA based on severity. ( 2.2 , 5.2 ) • Embryo-Fetal Toxicity : TUKYSA can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception…”

2 more passages

“…of TUKYSA in 2.3% of patients. 5.3 Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, TUKYSA can cause fetal harm when administer…”

“…rats and rabbits during organogenesis caused embryo-fetal mortality, reduced fetal weight and fetal abnormalities at maternal exposures ≥ 1.3 times the human exposure (AUC) at t…”

Reproductive / fertility toxicity
6 passages in the label

“…of reproductive potential that TUKYSA may impair fertility [see (8.3) ] . Refer to the Full Prescribing Information of trastuzumab and capecitabine for infertility information.…”

2 more passages

“…and capecitabine for contraception and infertility information. Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating tre…”

“…and capecitabine for lactation information. Infertility • Advise males and females of reproductive potential that TUKYSA may impair fertility [see (8.3) ] . Refer to the Ful…”

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

“…level. Grade 4 Permanently discontinue TUKYSA. Hepatotoxicity Abbreviations: ULN = upper limit of normal; ALT = alanine aminotransferase; AST = aspartate aminotransferase [see Wa…”

2 more passages

“…TUKYSA based on severity. ( 2.2 , 5.1 ) • Hepatotoxicity : Severe hepatotoxicity has been reported on TUKYSA. Monitor ALT, AST and bilirubin prior to starting TUKYSA, every…”

“…( 2.2 , 5.1 ) • Hepatotoxicity : Severe hepatotoxicity has been reported on TUKYSA. Monitor ALT, AST and bilirubin prior to starting TUKYSA, every 3 weeks during treatment…”

Set aside: found but not counted (5)
NegatedCarcinogenicity: “of creatinine via OCT2 and MATE1. 13 13.1 Carcinogenicity studies have not been conducted with tucatinib. Tucatinib was not mutagenic in an in vitro bacterial reverse mutat”
NegatedGenotoxicity / mutagenicity: “conducted with tucatinib. Tucatinib was not mutagenic in an in vitro bacterial reverse mutation (Ames) assay. Tucatinib was not clastogenic in either an in vitro chromosom”
NegatedGenotoxicity / mutagenicity: “mutation (Ames) assay. Tucatinib was not clastogenic in either an in vitro chromosome aberration assay or an in vivo mouse bone marrow micronucleus assay. Fertility studi”
NegatedGenotoxicity / mutagenicity: “was not clastogenic in either an in vitro chromosome aberration assay or an in vivo mouse bone marrow micronucleus assay. Fertility studies in animals have not been conducted. In repe”
NegatedGenotoxicity / mutagenicity: “assay or an in vivo mouse bone marrow micronucleus assay. Fertility studies in animals have not been conducted. In repeat-dose toxicity studies up to 13 weeks duration, d”
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.

TUKYSA (tucatinib): 3 of 6 NIOSH criteria in the label | Clariscope