TECENTRIQ (atezolizumab): 3 of 6 NIOSH criteria in the label

Screening report

Genentech, Inc. · Package insert of record

TECENTRIQ (atezolizumab)

Not on the NIOSH ListDailyMed

Developmental / reproductive language

The label notes developmental and/or reproductive toxicity. Many drugs carry this language and are not classified as hazardous.

3 / 6NIOSH hazard criteria present in this label

Special handling

Carcinogenicity

Developmental

Reproductive

Genotoxicity

Organ toxicity

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 e…”

2 more passages

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

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

Reproductive / fertility toxicity

2 passages in the label

Animal data

“…Females Based on animal studies, TECENTRIQ may impair fertility in females of reproductive potential while receiving treatment [see (13.1) ] . 8.4 Pediatric Use Alveolar Soft Part S…”

1 more passage

“…for at least 5 months following the last dose. Infertility Females Based on animal studies, TECENTRIQ may impair fertility in females of reproductive potential while receiving tr…”

Organ toxicity (verify at low doses)

53 passages in the label

“…frequent (≥ 2%) serious adverse reactions were hepatotoxicity (7%), pyrexia (6%), pneumonia (4.3%), malignant neoplasms (2.2%), and acute kidney injury (2.2%). Adverse reactions…”

2 more passages

“…edema 26 <1 21 0 Gastrointestinal Disorders Hepatotoxicity Includes alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, transa…”

“…increased, hepatitis, hepatic enzyme increased, hepatotoxicity, hypertransaminasemia, bilirubin conjugated increased, hepatocellular injury, hyperbilirubinemia, liver function tes…”

Drug-class hint

Context only · not counted

“…as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥ 1% of tumor cells,…”

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. Atezolizumab is a monoclonal antibody that binds to PD L”

NegatedCarcinogenicity: “to test the potential of atezolizumab for carcinogenicity or genotoxicity. Animal fertility studies have not been conducted with atezolizumab; however, an assessment of the”

Supporting onlyCarcinogenicity: “had known primary central nervous system (CNS) malignancy or symptomatic CNS metastases, known clinically significant liver disease, or history of idiopathic pulmonary fibrosis,”

NegatedGenotoxicity / mutagenicity: “of atezolizumab for carcinogenicity or genotoxicity. Animal fertility studies have not been conducted with atezolizumab; however, an assessment of the male and female”

NegatedDevelopmental / embryo-fetal toxicity: “As reported in the literature, there were no malformations related to the blockade of PD-L1/PD-1 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.