Screening report

Sun Pharmaceutical Industries, Inc. · Package insert of record

UNLOXCYT (cosibelimab)

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 to use ef…”

2 more passages

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

“…[ see Warnings and Precautions (5.1 , 5.3) ]. Embryo-Fetal Toxicity Advise females of reproductive potential that UNLOXCYT can cause harm to a fetus and to inform their healthcar…”

Organ toxicity (verify at low doses)
12 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 UNLOXCYT can cause immune-mediated pneumonitis. In patients treated with other PD-1/PD-L1-blocking antibodies, the inci…”

Set aside: found but not counted (5)
Supporting onlyManufacturer special-handling information: “T cells and antigen presenting cells suppresses cytotoxic T-cell activity, T-cell proliferation, and cytokine production. Cosibelimab-ipdl binds PD-L1 and blocks the interaction”
NegatedCarcinogenicity: “to assess the potential of cosibelimab-ipdl for carcinogenicity or genotoxicity. Fertility studies have not been conducted with cosibelimab-ipdl in animals. In 1- and 3-month rep”
Supporting onlyCarcinogenicity: “with other solid tumors and hematologic malignancies. UNLOXCYT was administered intravenously at doses of 800 mg every 2 weeks (n=174), 1,200 mg every 3 weeks (n=35), or ot”
NegatedGenotoxicity / mutagenicity: “of cosibelimab-ipdl for carcinogenicity or genotoxicity. Fertility studies have not been conducted with cosibelimab-ipdl in animals. In 1- and 3-month repeat-dose toxicol”
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”
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.