Screening report

Sanofi-Aventis U.S. LLC · Package insert of record

Sarclisa Escena (ISATUXIMAB-IRFC)

Not on the NIOSH ListDailyMed (opens the full label on DailyMed in a new tab)
Carcinogenic / genotoxic findings in the label
The label reports carcinogenicity and/or genotoxicity findings — among the criteria NIOSH uses to identify hazardous drugs.
2 / 6NIOSH hazard criteria present in this label
Special handling: not found
Carcinogenicity: present in the label
Developmental: present in the label
Reproductive: not found
Genotoxicity: not found
Organ toxicity: not found
Carcinogenicity
14 passages in the label

“…[see Dosage and Administration (2.3) ] . 5.4 Second Primary Malignancies Second primary malignancies were reported in 3.9% of patients in clinical trials with SARCLISA ESCENA in combinatio…”

2 more passages

“…(2.3) ] . 5.4 Second Primary Malignancies Second primary malignancies were reported in 3.9% of patients in clinical trials with SARCLISA ESCENA in combination with Pd, Kd, and VRd (IRAK…”

“…and Administration (2.3) ] . 5.4 Second Primary Malignancies Second primary malignancies were reported in 3.9% of patients in clinical trials with SARCLISA ESCENA in combination wi…”

Developmental / embryo-fetal toxicity
17 passages in the label

“…of complete response. ( 5.5 , 7.1 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. (…”

2 more passages

“…response. [see Drug Interactions (7.1) ] . 5.6 Embryo-Fetal Toxicity Based on its mechanism of action, isatuximab-irfc can cause fetal harm when administered to a pregnant woman.…”

“…(5.5) and Drug Interactions (7.1) ] . Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females o…”

Set aside: found but not counted (3)
Supporting onlyManufacturer special-handling information: “including antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and complement dependent cytotoxicity (CDC). Isatuximab-irf”
NegatedCarcinogenicity: “of SARCLISA ESCENA is unknown. 13 13.1 Carcinogenicity and genotoxicity studies have not been conducted with isatuximab-irfc. Fertility studies have not been conducted w”
NegatedGenotoxicity / mutagenicity: “is unknown. 13 13.1 Carcinogenicity and genotoxicity studies have not been conducted with isatuximab-irfc. Fertility studies have not been conducted with isatuximab-ir”
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.

Sarclisa Escena (ISATUXIMAB-IRFC): 2 of 6 NIOSH criteria in the label | Clariscope