Screening report

BeOne Medicines USA, Inc. · Package insert of record

TEVIMBRA (tislelizumab-jsgr)

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, TEVIMBRA can cause fetal harm when administered to a pregnant woman. Animal…”

“…(HSCT) [see Warnings and Precautions (5.3) ]. Embryo-Fetal Toxicity Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provi…”

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

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

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 TEVIMBRA can cause immune-mediated pneumonitis, which can be fatal. In patients treated with other PD-1/PD-L1 blocking…”

Drug-class hint
Context only · not counted

“…choice of a fluoropyrimidine- and platinum-based chemotherapy (CAPOX or FP), or trastuzumab 8 mg/kg loading dose (Cycle 1 Day 1) followed by 6 mg/kg intravenous infusio…”

Set aside: found but not counted (3)
NegatedCarcinogenicity: “assess the potential of tislelizumab-jsgr for carcinogenicity or genotoxicity. In a 3-month repeat-dose toxicology study in cynomolgus monkeys, there were no notable effects in”
NegatedGenotoxicity / mutagenicity: “of tislelizumab-jsgr for carcinogenicity or genotoxicity. In a 3-month repeat-dose toxicology study in cynomolgus monkeys, there were no notable effects in the male and fe”
NegatedDevelopmental / embryo-fetal toxicity: “As reported in the literature, there were no malformations related to the blockade of PD-1 signaling in the offspring of these animals; however, immune-mediated disorders occurr”
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.