Screening report

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

OPDIVO QVANTIG (NIVOLUMAB AND HYALURONIDASE-NVHY)

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
14 passages in the label

“…with a PD-1/PD-L1 blocking antibody. (5.2) • 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. 5.3 Embryo-Fetal Toxicity Based on its mechanism of action and data from animal studies, OPDIVO QVANTIG can cause fetal harm when admini…”

“…6-month postnatal period. Hyaluronidase In an embryo-fetal development study, mice were dosed daily by subcutaneous injection during the period of organogenesis with hyaluronidas…”

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

“…colitis, immune-mediated hepatitis and hepatotoxicity, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, and immune-mediated nephritis and…”

2 more passages

“…of colitis. Immune-Mediated Hepatitis and Hepatotoxicity OPDIVO QVANTIG can cause immune-mediated hepatitis, defined as requiring the use of corticosteroids and no clear alt…”

“…and cabozantinib were diarrhea, fatigue, hepatotoxicity, palmar-plantar erythrodysesthesia syndrome, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, d…”

Drug-class hint
Context only · not counted

“…patients who were refractory or intolerant to taxane therapy, had brain metastases that were symptomatic or required treatment, had autoimmune disease, used systemic cortic…”

Set aside: found but not counted (7)
NegatedCarcinogenicity: “to assess the potential of nivolumab for carcinogenicity or genotoxicity. Fertility studies have not been performed with nivolumab. In 1-month and 3-month repeat-dose toxi”
NegatedCarcinogenicity: “studies have not been performed to assess the carcinogenic or mutagenic potential of hyaluronidase. In addition, when subcutaneous hyaluronidase (recombinant human) was adminis”
Supporting onlyCarcinogenicity: “requiring treatment or history of prior malignancy within the previous 2 years; active, known, or suspected autoimmune disease; or who received prior treatment with a che”
NegatedGenotoxicity / mutagenicity: “been performed to assess the carcinogenic or mutagenic potential of hyaluronidase. In addition, when subcutaneous hyaluronidase (recombinant human) was administered to cyno”
NegatedGenotoxicity / mutagenicity: “potential of nivolumab for carcinogenicity or genotoxicity. Fertility studies have not been performed with nivolumab. In 1-month and 3-month repeat-dose toxicology studies i”
NegatedDevelopmental / embryo-fetal toxicity: “with nivolumab. The study found no evidence of teratogenicity. Reduced fetal weight and increased numbers of fetal resorptions were observed, with no effects found at a daily d”
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.