OPDUALAG (NIVOLUMAB AND RELATLIMAB-RMBW): 2 of 6 NIOSH criteria in the label

Screening report

E.R. Squibb & Sons, L.L.C. · Package insert of record

OPDUALAG (NIVOLUMAB AND RELATLIMAB-RMBW)

Not on the NIOSH ListDailyMed

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

Carcinogenicity

Developmental

Reproductive

Genotoxicity

Organ toxicity

Developmental / embryo-fetal toxicity

14 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 potential risk to a fetus and to use effec…”

2 more passages

“…prior to or after an allogeneic HSCT. 5.4 Embryo-Fetal Toxicity Based on its mechanism of action and data from animal studies, OPDUALAG can cause fetal harm when administered…”

“…[see Warnings and Precautions (5.3) ] . Embryo-Fetal Toxicity • Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare pro…”

Organ toxicity (verify at low doses)

12 passages in the label

“…Reactions [see Warnings and Precautions (5.1) ] Pneumonitis Grade 2 Withhold a Grade 3 or 4 Permanently discontinue Colitis Grade 2 or 3 Withhold a Grade 4 Permanently discontinue…”

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 OPDUALAG can cause immune-mediated pneumonitis, which may be fatal. In patients treated with other PD-1/PD-L1 blocking…”

Set aside: found but not counted (3)

NegatedCarcinogenicity: “the potential of nivolumab or relatlimab for carcinogenicity or genotoxicity. Fertility studies have not been performed with nivolumab or relatlimab. 13.2 Animal Toxicology an”

NegatedGenotoxicity / mutagenicity: “nivolumab or relatlimab for carcinogenicity or genotoxicity. Fertility studies have not been performed with nivolumab or relatlimab. 13.2 Animal Toxicology and/or Pharmacolog”

NegatedDevelopmental / embryo-fetal toxicity: “treated with nivolumab, there were no apparent malformations and no effects on neurobehavioral, immunological, or clinical pathology parameters throughout the 6-month postnatal pe”

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.