Screening report

GlaxoSmithKline LLC · Package insert of record

Jemperli (DOSTARLIMAB)

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 ef…”

2 more passages

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

“…[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 pro…”

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

“…including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated nephritis with r…”

2 more passages

“…reactions) are discussed below. Immune-Mediated Pneumonitis JEMPERLI can cause immune-mediated pneumonitis, which can be fatal. In patients treated with other PD-1/PD-L1-blocking…”

“…Pneumonitis JEMPERLI can cause immune-mediated pneumonitis, which can be fatal. In patients treated with other PD-1/PD-L1-blocking antibodies, the incidence of pneumonitis is hig…”

Set aside: found but not counted (4)
NegatedCarcinogenicity: “to assess the potential of dostarlimab-gxly for carcinogenicity or genotoxicity. Fertility studies have not been conducted with dostarlimab-gxly. In 1- and 3-month repeat-dose to”
NegatedGenotoxicity / mutagenicity: “of dostarlimab-gxly for carcinogenicity or genotoxicity. Fertility studies have not been conducted with dostarlimab-gxly. In 1- and 3-month repeat-dose toxicology studies”
NegatedDevelopmental / embryo-fetal toxicity: “As reported in the literature, there were no malformations related to the blockade of PD-1/PD-L1 signaling in the offspring of these animals; however, immune-mediated disorders”
NegatedOrgan toxicity (verify at low doses): “[see Warnings and Precautions ( 5.1 )] Pneumonitis Grade 2 Withhold b Grade 3 or 4 or recurrent Grade 2 Permanently discontinue Colitis Grade 2 or 3 Withhold b Grade 4 Pe”
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.