Screening report

Janssen Biotech, Inc. · Package insert of record

Darzalex Faspro (daratumumab and hyaluronidase-fihj (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
18 passages in the label

“…FASPRO to allow recovery of platelets. ( 5.5 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise pregnant women of the potential risk to a fetus and advise females of reproduct…”

2 more passages

“…FASPRO until recovery of platelets. 5.6 Embryo-Fetal Toxicity Based on the mechanism of action, DARZALEX FASPRO can cause fetal harm when administered to a pregnant woman.…”

“…[see Warnings and Precautions (5.5) ] . Embryo-Fetal Toxicity Advise pregnant women of the potential hazard to a fetus. Advise females of reproductive potential to inform t…”

Organ toxicity (verify at low doses)
1 passage in the label

“…recovery of blood cell counts in the event of myelosuppression [see Warnings and Precautions (5.4 , 5.5) ] . 2.8 Preparation and Administration DARZALEX FASPRO should be administered…”

Set aside: found but not counted (9)
Supporting onlyManufacturer special-handling information: “tumor cell lysis through complement dependent cytotoxicity (CDC), antibody dependent cell mediated cytotoxicity (ADCC) and antibody dependent cellular phagocytosis (ADCP). A s”
NegatedCarcinogenicity: “of daratumumab products. 13 13.1 No carcinogenicity or genotoxicity studies have been conducted with daratumumab. No animal studies have been performed to evaluate th”
NegatedCarcinogenicity: “effects on fertility in males or females. No carcinogenicity, genotoxicity, or fertility studies were conducted for recombinant human hyaluronidase. There were no effects on r”
NegatedCarcinogenicity: “form of the endogenous human hyaluronidase, no carcinogenicity, mutagenesis, or effects on fertility are expected. 14 CLINICAL STUDIES 14.1 Newly Diagnosed Multiple Myeloma In C”
NegatedGenotoxicity / mutagenicity: “human hyaluronidase, no carcinogenicity, mutagenesis, or effects on fertility are expected. 14 CLINICAL STUDIES 14.1 Newly Diagnosed Multiple Myeloma In Combination wit”
NegatedGenotoxicity / mutagenicity: “products. 13 13.1 No carcinogenicity or genotoxicity studies have been conducted with daratumumab. No animal studies have been performed to evaluate the potential effe”
NegatedGenotoxicity / mutagenicity: “in males or females. No carcinogenicity, genotoxicity, or fertility studies were conducted for recombinant human hyaluronidase. There were no effects on reproductive ti”
NegatedDevelopmental / embryo-fetal toxicity: “the human dose) and there were no effects on embryo-fetal development in pregnant mice given 360,000 U/kg hyaluronidase subcutaneously daily during organogenesis, which is 720 t”
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.