Screening report

Citius Pharmaceuticals, Inc. · Package insert of record

LYMPHIR (DENILEUKIN DIFTITOX-CXDL)

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.
3 / 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: present in the label
Developmental / embryo-fetal toxicity
14 passages in the label

“…treatment as clinically indicated. ( 5.4 ) 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

“…[see Dosage and Administration ( 2.4 )] . 5.5 Embryo-Fetal Toxicity Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman. Verify t…”

“…[see Warnings and Precautions ( 5.4 )]. Embryo-Fetal Toxicity Advise pregnant women and female patients of reproductive potential of the potential risk to a fetus. Advise f…”

Reproductive / fertility toxicity
1 passage in the label
Animal data

“…LYMPHIR and for 7 days after the last dose. Infertility Males Based on findings in rats, male fertility may be compromised by treatment with LYMPHIR [see ( 13.1 )] . The rev…”

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

“…Grade 3 Permanently discontinue LYMPHIR. Hepatotoxicity [see Warnings and Precautions ( 5.4 )] Grade 2: ALT/AST 3 to 5 x upper limit of normal (ULN) Maintain LYMPHIR dose M…”

2 more passages

“…reactions based on severity. ( 5.3 ) Hepatotoxicity: Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. ( 5.4 ) Embryo-Fetal…”

“…Institute appropriate medical management. 5. 4 Hepatotoxicity LYMPHIR can cause hepatotoxicity. In the pooled safety population, elevated ALT occurred in 70% of patients, with Gr…”

Set aside: found but not counted (5)
NegatedCarcinogenicity: “There have been no studies to assess the carcinogenic potential of denileukin diftitox-cxdl. Denileukin diftitox-cxdl showed no evidence of mutagenicity in the Ames test a”
NegatedGenotoxicity / mutagenicity: “Denileukin diftitox-cxdl showed no evidence of mutagenicity in the Ames test and the chromosomal aberration assay. There have been no studies to assess the effect of denileuk”
NegatedGenotoxicity / mutagenicity: “of mutagenicity in the Ames test and the chromosomal aberration assay. There have been no studies to assess the effect of denileukin diftitox on fertility. In a 14-week repeat-dose to”
NegatedGenotoxicity / mutagenicity: “showed no evidence of mutagenicity in the Ames test and the chromosomal aberration assay. There have been no studies to assess the effect of denileukin diftitox on fertili”
NegatedDevelopmental / embryo-fetal toxicity: “risk. No animal reproductive and developmental toxicity studies have been conducted with denileukin diftitox. Denileukin diftitox-cxdl causes depletion of regulatory T lymphoc”
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.