Screening report

Immunocore Commercial LLC · Package insert of record

KIMMTRAK (TEBENTAFUSP)

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.
1 / 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: not found
Developmental / embryo-fetal toxicity
14 passages in the label

“…ALT, AST, and total bilirubin ( 2.3 , 5.3 ). Embryo-Fetal toxicity : May cause fetal harm. Advise patients of reproductive potential of the potential risk to the fetus and to us…”

2 more passages

“…[see Dosage and Administration (2.3) ] . 5.4 Embryo-Fetal Toxicity Based on the mechanism of action, KIMMTRAK may cause fetal harm when administered to a pregnant woman. Advise…”

“…[see Warnings and Precautions (5.3) ] . Embryo-Fetal Toxicity Advise females to inform their healthcare provider if they are pregnant or become pregnant. Inform females of…”

Set aside: found but not counted (3)
NegatedCarcinogenicity: “not been fully characterized. 13 13.1 No carcinogenicity or genotoxicity studies have been conducted with tebentafusp-tebn. No studies have been conducted to evaluate the”
NegatedGenotoxicity / mutagenicity: “13 13.1 No carcinogenicity or genotoxicity studies have been conducted with tebentafusp-tebn. No studies have been conducted to evaluate the effects of teben”
NegatedDevelopmental / embryo-fetal toxicity: “in pregnant woman. No animal reproductive and developmental toxicity studies have been conducted with KIMMTRAK. Molecules of similar molecular weight can cross the placenta resulting in fe”
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.