Screening report

Genmab US, Inc. · Package insert of record

EPKINLY (EPCORITAMAB-BYSP)

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

“…blood cell counts during treatment. ( 5.4 ) Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use…”

2 more passages

“…factor administration as applicable. 5.5 Embryo-Fetal Toxicity Based on its mechanism of action, EPKINLY may cause fetal harm when administered to a pregnant woman. Advise p…”

“…[see Warnings and Precautions (5.4) ] . Embryo-Fetal Toxicity Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform the…”

Set aside: found but not counted (4)
Supporting onlyManufacturer special-handling information: “and rituximab resulted in both T-cell mediated cytotoxicity and natural killer (NK) cell mediated antibody-dependent cellular cytotoxicity (ADCC). 12.2 Pharmacodynamics Circula”
NegatedCarcinogenicity: “of epcoritamab-bysp is unknown. 13 13.1 No carcinogenicity or genotoxicity studies have been conducted with epcoritamab-bysp. No dedicated studies have been conducted to eva”
NegatedGenotoxicity / mutagenicity: “is unknown. 13 13.1 No carcinogenicity or genotoxicity studies have been conducted with epcoritamab-bysp. No dedicated studies have been conducted to evaluate the effect”
NegatedDevelopmental / embryo-fetal toxicity: “drug-associated risk. No animal reproductive or developmental toxicity studies have been conducted with epcoritamab-bysp. Epcoritamab-bysp causes T-cell activation and cytokine release; immu”
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.