Screening report

USWM, LLC · Package insert of record

iwilfin (EFLORNITHINE HYDROCHLORIDE)

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.
3 / 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: present in the label
Carcinogenicity
2 passages in the label

“…normal renal function. 13 13.1 In a 2-year carcinogenicity study, once daily oral administration of eflornithine to female rats did not result in drug-related neoplasms at d…”

1 more passage

“…metabolism, by decreasing expression of the oncogenic drivers MYCN and LIN28B in MYCN -amplified neuroblastoma. In vitro, eflornithine induced senescence and suppressed neur…”

Developmental / embryo-fetal toxicity
17 passages in the label

“…discontinue based on severity. ( 5.3 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use ef…”

2 more passages

“…Dosage and Administration (2.1 , 2.4) ]. 5.4 Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, IWILFIN can cause fetal harm when administe…”

“…risk to a fetus. Data Animal Data In an embryo-fetal development study, once daily oral administration of 30, 80 or 200 mg/kg/day eflornithine to pregnant rats during the p…”

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

“…Resume IWILFIN at the next reduced dose level. Hepatotoxicity [see Warnings and Precautions (5.2) ] Aspartate aminotransferase increased or Alanine aminotransferase increased AST…”

2 more passages

“…discontinue based on severity. ( 5.1 ) Hepatotoxicity: Monitor liver function tests before and during treatment with IWILFIN. Withhold, reduce dose, or permanently discon…”

“…[see Dosage and Administration (2.4) ]. 5.2 Hepatotoxicity IWILFIN can cause hepatotoxicity. In the pooled safety population [see Adverse Reactions (6.1) ] , Grade 3 or 4 even…”

Set aside: found but not counted (4)
Supporting onlyManufacturer special-handling information: “non-amplified neuroblastoma cells, indicating a cytostatic effect. Treatment with eflornithine prevented or delayed tumor formation in mice injected with limiting dilutions of MY”
NegatedGenotoxicity / mutagenicity: “of 1152 ± 384 mg/m 2 ). Eflornithine was not mutagenic in the in vitro bacterial reverse mutation (Ames) assay. Dedicated fertility studies were not conducted with eflornit”
NegatedDevelopmental / embryo-fetal toxicity: “was no clear evidence of eflornithine-related fetal malformations in rats or rabbits. 8.2 Lactation Risk Summary There are no data on the presence of eflornithine in human milk, the ef”
NegatedDevelopmental / embryo-fetal toxicity: “no clear evidence of eflornithine-related fetal malformations in rats or rabbits. 8.2 Lactation Risk Summary There are no data on the presence of eflornithine in human milk, the ef”
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.