Screening report

AstraZeneca Pharmaceuticals LP · Package insert of record

IMFINZI (DURVALUMAB)

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. ( 5.3 ) • 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

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

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

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

“…plus chemotherapy. These include pneumonitis, hepatotoxicity, neurotoxicity, sepsis, diabetic ketoacidosis and pancytopenia (1 patient each). Serious adverse reactions occurred…”

2 more passages

“…COVID-19 pneumonia, pneumonia aspiration, interstitial lung disease and aortic aneurysm. Permanent discontinuation of adjuvant IMFINZI due to an adverse reaction occurred in 8% of patient…”

“…Includes acute interstitial pneumonitis, interstitial lung disease, pneumonitis, pulmonary fibrosis. /Radiation Pneumonitis 34 3.4 25 3 Dyspnea Includes dyspnea, and exertional dyspnea.…”

Drug-class hint
Context only · not counted

“…disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. ( 1.1 ) • in combination with tremelimumab-actl and platinum-based chemotherapy, fo…”

Set aside: found but not counted (3)
Supporting onlyManufacturer special-handling information: “By binding to its receptors, PD-L1 reduces cytotoxic T-cell activity, proliferation, and cytokine production. Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclon”
NegatedCarcinogenicity: “of IMFINZI is unknown. 13 13.1 The carcinogenic and genotoxic potential of durvalumab have not been evaluated. Animal fertility studies have not been conducted with”
NegatedGenotoxicity / mutagenicity: “is unknown. 13 13.1 The carcinogenic and genotoxic potential of durvalumab have not been evaluated. Animal fertility studies have not been conducted with durvalumab. In”
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.