Screening report

Genentech, Inc. · Package insert of record

Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)

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.
3 / 6NIOSH hazard criteria present in this label
Special handling: not found
Carcinogenicity: not found
Developmental: present in the label
Reproductive: present in the label
Genotoxicity: not found
Organ toxicity: present in the label
Developmental / embryo-fetal toxicity
17 passages in the label

“…complications and intervene promptly. ( 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 HYBREZA can cause fetal harm when administered to a pregnant woman…”

“…normal immune response. Hyaluronidase : In an embryo-fetal study, mice were dosed daily by subcutaneous injection during the period of organogenesis with hyaluronidase (recombina…”

Reproductive / fertility toxicity
2 passages in the label

“…and for 5 months following the last dose. Infertility Females: Based on animal studies, TECENTRIQ HYBREZA may impair fertility in females of reproductive potential while rec…”

1 more passage

Animal study“…Based on animal studies, TECENTRIQ HYBREZA may impair fertility in females of reproductive potential while receiving TECENTRIQ HYBREZA treatment [see (13.1) ] . 8.4 Pediatric Use Al…”

Organ toxicity (verify at low doses)
24 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 TECENTRIQ HYBREZA can cause immune-mediated pneumonitis, including fatal adverse reactions. The incidence of pneumoniti…”

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 (8)
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”
NegatedCarcinogenicity: “studies have not been performed to assess the carcinogenic or mutagenic potential of hyaluronidase. In addition, when up to 220,000 units/kg of subcutaneous hyaluronidase (reco”
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: “been performed to assess the carcinogenic or mutagenic potential of hyaluronidase. In addition, when up to 220,000 units/kg of subcutaneous hyaluronidase (recombinant human”
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: “the human dose. The study found no evidence of teratogenicity. Reduced fetal weight and increased numbers of fetal resorptions were observed, with no effects found at a daily d”
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.