Screening report

Regeneron Pharmaceuticals, Inc. · Package insert of record

LYNOZYFIC (linvoseltamab-gcpt)

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

“…treatment as clinically indicated. ( 5.6 ) 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) ]. 5.7 Embryo-Fetal Toxicity Based on its mechanism of action, LYNOZYFIC may cause fetal harm when administered to a pregnant woman. Advise…”

“…jaundice [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)
5 passages in the label

“…and periodically during treatment. ( 5.5 ) Hepatotoxicity: Can cause hepatotoxicity. Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indica…”

2 more passages

“…treatment. ( 5.5 ) Hepatotoxicity: Can cause hepatotoxicity. Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. ( 5.6 ) Embryo-Fetal…”

“…[see Dosage and Administration (2.5) ] . 5.6 Hepatotoxicity LYNOZYFIC can cause hepatotoxicity. In LINKER-MM1, elevated ALT occurred in 46% of patients, with Grade 3 or 4 ALT e…”

Drug-class hint
Context only · not counted

“…of patients were previously treated with a BCMA antibody-drug conjugate. Efficacy was established based on objective response rate (ORR) as determined by blinded independent review committee…”

Set aside: found but not counted (3)
NegatedCarcinogenicity: “products is unknown. 13 13.1 No carcinogenicity or genotoxicity studies have been conducted with linvoseltamab-gcpt. No animal studies have been performed to eval”
NegatedGenotoxicity / mutagenicity: “is unknown. 13 13.1 No carcinogenicity or genotoxicity studies have been conducted with linvoseltamab-gcpt. No animal studies have been performed to evaluate the effects”
NegatedDevelopmental / embryo-fetal toxicity: “drug associated risk. No animal reproductive or developmental toxicity studies have been conducted with LYNOZYFIC. Linvoseltamab-gcpt causes T-cell activation and cytokine release; immune ac”
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.