Screening report

Coherus Oncology, Inc. · Package insert of record

LOQTORZI (TORIPALIMAB-TPZI)

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 e…”

2 more passages

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

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

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

“…reactions. Colitis resolved in all 3 patients. Hepatotoxicity and Immune-Mediated Hepatitis LOQTORZI in Combination with Cisplatin and Gemcitabine LOQTORZI in combination with ci…”

2 more passages

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

“…including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated nephritis with r…”

Drug-class hint
Context only · not counted

“…or metastatic NPC who had received prior platinum-based chemotherapy for treatment of recurrent or metastatic NPC or had disease progression within 6 months of completion of p…”

Set aside: found but not counted (3)
NegatedCarcinogenicity: “to test the potential of toripalimab-tpzi for carcinogenicity or genotoxicity. Fertility studies have not been conducted with toripalimab-tpzi. In 4-week and 26-week repeat-dos”
NegatedGenotoxicity / mutagenicity: “of toripalimab-tpzi for carcinogenicity or genotoxicity. Fertility studies have not been conducted with toripalimab-tpzi. In 4-week and 26-week repeat-dose toxicology stu”
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.