Screening report

Amgen, Inc · Package insert of record

BLINCYTO (BLINATUMOMAB)

NIOSH Table 2DailyMed (opens the full label on DailyMed in a new tab)
On the NIOSH List — Table 2
This drug appears on the NIOSH List of Hazardous Drugs, 2024 (Table 2).
1 / 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: not found
Developmental / embryo-fetal toxicity
14 passages in the label

“…weighing less than 5.4 kg [see (8.4) ] . 5.13 Embryo-Fetal Toxicity Based on its mechanism of action, BLINCYTO may cause fetal harm when administered to a pregnant woman. Advise…”

2 more passages

“…have not been conducted with blinatumomab. In embryo-fetal developmental toxicity studies, a murine surrogate molecule was administered intravenously to pregnant mice during the…”

“…contact their doctor or nurse immediately. Embryo-Fetal Toxicity Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform the…”

Set aside: found but not counted (7)
NegatedCarcinogenicity: “or effectiveness of BLINCYTO. 13 13.1 No carcinogenicity or genotoxicity studies have been conducted with blinatumomab. No studies have been conducted to evaluate the effe”
NegatedGenotoxicity / mutagenicity: “of BLINCYTO. 13 13.1 No carcinogenicity or genotoxicity studies have been conducted with blinatumomab. No studies have been conducted to evaluate the effects of blinatumo”
NegatedDevelopmental / embryo-fetal toxicity: “and did not cause embryo-fetal toxicity or teratogenicity. The expected depletions of B and T cells were observed in the pregnant mice, but hematological effects were not a”
NegatedDevelopmental / embryo-fetal toxicity: “weighing less than 5.4 kg. ( 5.12 , 8.4 ) Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use”
NegatedDevelopmental / embryo-fetal toxicity: “crossed the placental barrier and did not cause embryo-fetal toxicity or teratogenicity. The expected depletions of B and T cells were observed in the pregnant mice, but hematologi”
NegatedDevelopmental / embryo-fetal toxicity: “less than 5.4 kg. ( 5.12 , 8.4 ) Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective”
NegatedDevelopmental / embryo-fetal toxicity: “the placental barrier and did not cause embryo-fetal toxicity or teratogenicity. The expected depletions of B and T cells were observed in the pregnant mice, but hematological effec”
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.