Screening report

Akeso Biopharma, Co., Ltd · Package insert of record

Penpulimab kcqx (PENPULIMAB)

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, penpulimab-kcqx can cause fetal harm when administered to a pregnant woman.…”

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

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

“…colitis, immune-mediated hepatitis and hepatotoxicity, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis and ren…”

2 more passages

“…of patients. Immune-Mediated Hepatitis and Hepatotoxicity Penpulimab-kcqx can cause immune-mediated hepatitis. Penpulimab-kcqx in Combination with Either Cisplatin or Carbopl…”

“…including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis and hepatotoxicity, immune-mediated endocrinopathies, immune-mediat…”

Drug-class hint
Context only · not counted

“…NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. ( 1.2 ) 1.1 First-line Treatment of Recurrent or Metastatic…”

Set aside: found but not counted (4)
NegatedCarcinogenicity: “to assess the potential of penpulimab-kcqx for carcinogenicity or genotoxicity. Fertility studies have not been conducted with penpulimab-kcqx. In 6-week and 3-month repeat dose”
NegatedGenotoxicity / mutagenicity: “of penpulimab-kcqx for carcinogenicity or genotoxicity. Fertility studies have not been conducted with penpulimab-kcqx. In 6-week and 3-month repeat dose toxicology stud”
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): “Reactions [see Warnings and Precautions (5.1) ] Pneumonitis Grade 2 Withhold † Grade 3 or 4 Permanently discontinue Colitis Grade 2 or 3 Withhold † Grade 4 Permanently discontinue”
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.