Screening report

Janssen Biotech, Inc. · Package insert of record

Rybrevant Faspro (AMIVANTAMAB AND HYALURONIDASE-LPUJ (HUMAN RECOMBINANT))

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
22 passages in the label

“…RYBREVANT FASPRO based on severity. ( 5.5 ) Embryo-Fetal Toxicity : Can 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 (2.8) ] . 5.6 Embryo-Fetal Toxicity Based on its mechanism of action and findings from animal models, RYBREVANT FASPRO can cause fetal harm when a…”

“…in an increased incidence of impairment of embryo-fetal development, embryo lethality, and abortion. Verify pregnancy status of females of reproductive potential prior to init…”

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

“…4 Permanently discontinue RYBREVANT FASPRO. Interstitial Lung Disease (ILD)/pneumonitis [see Warnings and Precautions (5.2) ] Any Grade Withhold RYBREVANT FASPRO if ILD/pneumonitis is suspe…”

2 more passages

“…FASPRO based on severity. ( 2.8 , 5.1 ) Interstitial Lung Disease (ILD)/Pneumonitis : Monitor for new or worsening symptoms indicative of ILD/pneumonitis. Immediately withhold RYBREVANT…”

“…[see Dosage and Administration (2.8) ] . 5.2 Interstitial Lung Disease/Pneumonitis RYBREVANT FASPRO can cause severe and fatal interstitial lung disease (ILD)/pneumonitis. RYBREVANT FASPRO (…”

Drug-class hint
Context only · not counted

“…test, whose disease has progressed on or after platinum-based chemotherapy. ( 1 , 2.2 ) 1.1 First-Line Treatment of NSCLC with EGFR Exon 19 Deletions or Exon 21 L858R Substitution M…”

Set aside: found but not counted (7)
Supporting onlyManufacturer special-handling information: “through antibody-dependent cellular cytotoxicity (ADCC) and trogocytosis mechanisms, respectively. Hyaluronan is a polysaccharide found in the extracellular matrix o”
NegatedCarcinogenicity: “to assess the potential of amivantamab for carcinogenicity or genotoxicity. Fertility studies have not been performed to evaluate the potential effects of amivantamab. In 6-”
NegatedCarcinogenicity: “studies have not been performed to assess the carcinogenic or mutagenic potential of hyaluronidase. In addition, when hyaluronidase (recombinant human) was administered to cyno”
NegatedGenotoxicity / mutagenicity: “been performed to assess the carcinogenic or mutagenic potential of hyaluronidase. In addition, when hyaluronidase (recombinant human) was administered to cynomolgus monkey”
NegatedGenotoxicity / mutagenicity: “potential of amivantamab for carcinogenicity or genotoxicity. Fertility studies have not been performed to evaluate the potential effects of amivantamab. In 6-week and 3-month”
NegatedDevelopmental / embryo-fetal toxicity: “the human dose. The study found no evidence of teratogenicity. Reduced fetal weight and increased numbers of fetal resorptions were observed, with no effects found at a daily d”
NegatedDevelopmental / embryo-fetal toxicity: “MET signaling has resulted in embryo lethality, malformations, and post-natal death in animals (see Data ). Advise pregnant women and females of reproductive potential of the poten”
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.