Screening report

Regeneron Pharmaceuticals, Inc. · Package insert of record

LIBTAYO (CEMIPLIMAB-RWLC)

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.
2 / 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: present in the label
Developmental / embryo-fetal toxicity
16 passages in the label

“…with a PD-1/PD-L1 blocking antibody. ( 5.3 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of ef…”

2 more passages

“…prior to or after an allogeneic HSCT. 5.4 Embryo-Fetal Toxicity Based on its mechanism of action, LIBTAYO can cause fetal harm when administered to a pregnant woman. Animal s…”

“…[see Warnings and Precautions (5.3) ]. Embryo-Fetal Toxicity Advise females of reproductive potential that LIBTAYO can cause harm to a fetus and to inform their healthcare…”

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

“…Reactions [see Warnings and Precautions (5.1) ] Pneumonitis Grade 2 Withhold Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. Perm…”

2 more passages

“…including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adv…”

“…reactions) are discussed below. Immune-Mediated Pneumonitis LIBTAYO can cause immune-mediated pneumonitis. The definition of immune-mediated pneumonitis included the required use…”

Drug-class hint
Context only · not counted

“…Cell Lung Cancer (NSCLC) in combination with platinum-based chemotherapy for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) with no EGFR, ALK o…”

Set aside: found but not counted (4)
NegatedCarcinogenicity: “to assess the potential of cemiplimab-rwlc for carcinogenicity or genotoxicity. In a 3-month repeat-dose toxicology study in sexually mature cynomolgus monkeys, there were no ce”
NegatedGenotoxicity / mutagenicity: “of cemiplimab-rwlc for carcinogenicity or genotoxicity. In a 3-month repeat-dose toxicology study in sexually mature cynomolgus monkeys, there were no cemiplimab-rwlc-re”
NegatedDevelopmental / embryo-fetal toxicity: “As reported in the literature, there were no malformations related to the blockade of PD-1/PD-L1 signaling in the offspring of these animals; however, immune-mediated disorders”
NegatedOrgan toxicity (verify at low doses): “pneumonitis. The definition of immune-mediated pneumonitis included the required use of systemic corticosteroids or other immunosuppressants and the absence of a clear alternate”
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.