Screening report

Amgen, Inc · Package insert of record

IMDELLTRA (AMG757) (Tarlatamab-dlle)

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
15 passages in the label

“…[see Dosage and Administration (2.5) ] . 5.7 Embryo-Fetal Toxicity Based on its mechanism of action, IMDELLTRA may cause fetal harm when administered to a pregnant woman. Advise…”

2 more passages

“…not been conducted with tarlatamab-dlle. In an embryo-fetal developmental toxicity study, a murine surrogate molecule was administered intravenously to pregnant mice during the pe…”

“…[see Warnings and Precautions (5.6) ] . Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females o…”

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

“…1 . Grade 4 Permanently discontinue IMDELLTRA. Hepatotoxicity [see Warnings and Precautions (5.5) ] Grade 3 Increased ALT or AST or bilirubin Withhold IMDELLTRA until improved to…”

2 more passages

“…discontinue based on severity. ( 5.4 ) Hepatotoxicity : Monitor liver enzymes and bilirubin prior to administration of all doses of IMDELLTRA up through Cycle 5 Day 15 an…”

“…[see Dosage and Administration (2.5) ] . 5.5 Hepatotoxicity IMDELLTRA can cause hepatotoxicity. In the pooled safety population [see Adverse Reactions (6.1) ] , based on labora…”

Drug-class hint
Context only · not counted

“…(ES-SCLC) with disease progression on or after platinum-based chemotherapy. IMDELLTRA is a bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager indicated for the treatm…”

Set aside: found but not counted (8)
NegatedManufacturer special-handling information: “specified administration conditions. The use of Closed System Transfer Device (CSTD) is not recommended due to potential wrong dose medication error risk. Amgen has not performed co”
NegatedManufacturer special-handling information: “The use of Closed System Transfer Device (CSTD) is not recommended due to potential wrong dose medication error risk. Amgen has not performed compatibility testing of”
NegatedManufacturer special-handling information: “performed compatibility testing of vial adaptor CSTDs with IMDELLTRA. Step 1: Reconstitute IMDELLTRA with Sterile Water for Injection Table 8 provides the required amount o”
NegatedCarcinogenicity: “of tarlatamab-dlle is unknown. 13 13.1 No carcinogenicity or genotoxicity studies have been conducted with tarlatamab-dlle. No studies have been conducted to evaluate the e”
NegatedGenotoxicity / mutagenicity: “is unknown. 13 13.1 No carcinogenicity or genotoxicity studies have been conducted with tarlatamab-dlle. No studies have been conducted to evaluate the effects of tarlat”
NegatedDevelopmental / embryo-fetal toxicity: “maternal toxicity, embryo-fetal toxicity or teratogenicity. 8.2 Lactation Risk Summary There are no data on the presence of tarlatamab-dlle in human milk or the effects on t”
NegatedDevelopmental / embryo-fetal toxicity: “barrier and did not cause maternal toxicity, embryo-fetal toxicity or teratogenicity. 8.2 Lactation Risk Summary There are no data on the presence of tarlatamab-dlle in human mi”
NegatedDevelopmental / embryo-fetal toxicity: “and did not cause maternal toxicity, embryo-fetal toxicity or teratogenicity. 8.2 Lactation Risk Summary There are no data on the presence of tarlatamab-dlle in human milk or the”
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.