Screening report
VYLOY (ZOLBETUXIMAB)
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: present in the label
Genotoxicity: not found
Organ toxicity: not found
Developmental / embryo-fetal toxicity
1 passage in the label
“…the potential risk. Data Animal Data In an embryo-fetal development toxicity study, zolbetuximab-clzb was intravenously administered to pregnant mice during the period of orga…”
Reproductive / fertility toxicity
1 passage in the label
“…for pregnancy testing, contraception, and infertility information. 8.4 Pediatric Use The safety and effectiveness of VYLOY in pediatric patients have not been established. 8…”
Set aside: found but not counted (8)
NegatedManufacturer special-handling information: “No incompatibilities have been observed with o closed system transfer devices composed of PP, PE, stainless steel, silicone (rubber/oil/resin), polyisoprene, PVC with TOTM plastici”
Supporting onlyManufacturer special-handling information: “cells via antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Zolbetuximab-clzb in combination with chemotherapy had increased”
NegatedCarcinogenicity: “performed with zolbetuximab-clzb to evaluate carcinogenicity, mutagenicity, or . 14 CLINICAL STUDIES SPOTLIGHT The efficacy of VYLOY in combination with mFOLFOX6 was evaluate”
NegatedGenotoxicity / mutagenicity: “zolbetuximab-clzb to evaluate carcinogenicity, mutagenicity, or . 14 CLINICAL STUDIES SPOTLIGHT The efficacy of VYLOY in combination with mFOLFOX6 was evaluated in SPOTLIGHT”
NegatedDevelopmental / embryo-fetal toxicity: “women to inform any drug-associated risks. Embryo-fetal toxicity was not observed in pregnant mice intravenously administered zolbetuximab-clzb [see Data] . VYLOY should only”
NegatedDevelopmental / embryo-fetal toxicity: “period of organogenesis and did not result in embryo-fetal toxicity at doses up to 300 mg/kg (approximately 1.9 times the recommended clinical dose based on AUC). Zolbetuximab-cl”
NegatedDevelopmental / embryo-fetal toxicity: “to inform any drug-associated risks. Embryo-fetal toxicity was not observed in pregnant mice intravenously administered zolbetuximab-clzb [see Data] . VYLOY should only be given”
NegatedDevelopmental / embryo-fetal toxicity: “of organogenesis and did not result in embryo-fetal toxicity at doses up to 300 mg/kg (approximately 1.9 times the recommended clinical dose based on AUC). Zolbetuximab-clzb crosse”
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.