Screening report

AstraZeneca Pharmaceuticals LP · Package insert of record

IMJUDO (TREMELIMUMAB)

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
15 passages in the label

“…on the severity of the reaction. ( 5.2 ) • 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

“…including Grade 3 (0.3%) adverse reactions. 5.3 Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, IMJUDO can cause fetal harm when administer…”

“…[see Warnings and Precautions (5.2) ] . Embryo-Fetal Toxicity: • Advise females of reproductive potential that IMJUDO can cause harm to a fetus and to inform their healthca…”

Organ toxicity (verify at low doses)
8 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 nephritis with r…”

“…reactions) are discussed below. Immune-Mediated Pneumonitis IMJUDO in combination with durvalumab can cause immune-mediated pneumonitis, which may be fatal. IMJUDO with Durvalumab…”

Drug-class hint
Context only · not counted

“…( 1.1 ) • in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing…”

Set aside: found but not counted (4)
Supporting onlyManufacturer special-handling information: “) 08/2026 1 INDICATIONS AND USAGE IMJUDO is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated: • in combination with durvalumab, for the treat”
NegatedCarcinogenicity: “tremelimumab-actl is unknown. 13 13.1 The carcinogenic and genotoxic potential of tremelimumab-actl have not been evaluated. Animal fertility studies have not been conducte”
NegatedGenotoxicity / mutagenicity: “is unknown. 13 13.1 The carcinogenic and genotoxic potential of tremelimumab-actl have not been evaluated. Animal fertility studies have not been conducted with tremeli”
NegatedDevelopmental / embryo-fetal toxicity: “associated with maternal toxicity or effects on embryo-fetal development at exposure levels approximately 4 to 31-times higher than those observed at a recommended dose range of 75”
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.