Screening report

Janssen Biotech, Inc. · Package insert of record

TALVEY (TALQUETAMAB)

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
14 passages in the label

“…discontinuation based on severity. ( 5.8 ) Embryo-Fetal Toxicity : May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use…”

2 more passages

“…[see Dosage and Administration (2.5) ] . 5.9 Embryo-Fetal Toxicity Based on its mechanism of action, TALVEY may cause fetal harm when administered to a pregnant woman. Advise pr…”

“…jaundice [see Warnings and Precautions (5.8) ]. 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)
4 passages in the label

“…as recommended based on severity. ( 5.7 ) Hepatotoxicity: Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold or consider…”

2 more passages

“…[see Dosage and Administration (2.5) ] . 5.8 Hepatotoxicity TALVEY can cause hepatotoxicity. In the clinical trial, elevated ALT occurred in 33% of patients, with Grade 3 or 4…”

“…(2.5) ] . 5.8 Hepatotoxicity TALVEY can cause hepatotoxicity. In the clinical trial, elevated ALT occurred in 33% of patients, with Grade 3 or 4 ALT elevation occurring in 2.7%;…”

Set aside: found but not counted (3)
NegatedCarcinogenicity: “or effectiveness of TALVEY. 13 13.1 No carcinogenicity or genotoxicity studies have been conducted with talquetamab-tgvs. No studies have been conducted to evaluate the”
NegatedGenotoxicity / mutagenicity: “of TALVEY. 13 13.1 No carcinogenicity or genotoxicity studies have been conducted with talquetamab-tgvs. No studies have been conducted to evaluate the effects of talqu”
NegatedDevelopmental / embryo-fetal toxicity: “drug associated risk. No animal reproductive or developmental toxicity studies have been conducted with talquetamab-tgvs. Talquetamab-tgvs causes T-cell activation and cytokine release; immu”
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.