Screening report

Janssen Biotech, Inc. · Package insert of record

TECVAYLI (TECLISTAMAB-CQYV)

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

“…of TECVAYLI based on severity. ( 2.5 , 5.7 ) 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) ] . 5.8 Embryo-Fetal Toxicity Based on its mechanism of action, TECVAYLI may cause fetal harm when administered to a pregnant patient. Advis…”

“…[see Warnings and Precautions (5.7) ]. Embryo-Fetal Toxicity Advise pregnant patients and females of reproductive potential of the potential risk to a fetus. Advise female…”

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

“…None. None. ( 4 ) 5 WARNINGS AND PRECAUTIONS Hepatotoxicity : Can cause hepatotoxicity, including fatalities. Monitor liver enzymes and bilirubin at baseline and during treatme…”

2 more passages

“…AND PRECAUTIONS Hepatotoxicity : Can cause hepatotoxicity, including fatalities. Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated.…”

“…or by telephone at 1-855-810-8064. 5.4 Hepatotoxicity TECVAYLI can cause hepatotoxicity, including fatalities. There was one fatal case of hepatic failure in MajesTEC-1.…”

Set aside: found but not counted (3)
NegatedCarcinogenicity: “teclistamab products is unknown. 13 13.1 No carcinogenicity or genotoxicity studies have been conducted with teclistamab-cqyv. No studies have been conducted to evaluate the”
NegatedGenotoxicity / mutagenicity: “is unknown. 13 13.1 No carcinogenicity or genotoxicity studies have been conducted with teclistamab-cqyv. No studies have been conducted to evaluate the effects of tecli”
NegatedDevelopmental / embryo-fetal toxicity: “drug associated risk. No animal reproductive or developmental toxicity studies have been conducted with TECVAYLI. Teclistamab-cqyv causes T-cell activation and cytokine release; immune activ”
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.