Screening report

Takeda Pharmaceuticals America, Inc. · Package insert of record

Iclusig (PONATINIB HYDROCHLORIDE)

NIOSH Table 2DailyMed (opens the full label on DailyMed in a new tab)
On the NIOSH List — Table 2
This drug appears on the NIOSH List of Hazardous Drugs, 2024 (Table 2).
4 / 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: present in the label
Organ toxicity: present in the label
Genotoxicity / mutagenicity
2 passages in the label

“…assay in human lymphocytes, nor was it clastogenic in an in vivo mouse micronucleus assay at oral doses up to 2000 mg/kg. Ponatinib may impair female fertility. In a fe…”

1 more passage

“…nor was it clastogenic in an in vivo mouse micronucleus assay at oral doses up to 2000 mg/kg. Ponatinib may impair female fertility. In a fertility study in male and female ra…”

Developmental / embryo-fetal toxicity
18 passages in the label

“…has not been established. ( 5.16 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use e…”

2 more passages

“…with gastrointestinal perforation. 5.17 Embryo-Fetal Toxicity Based on its mechanism of action and findings from animal studies, ICLUSIG can cause fetal harm when administe…”

“…Data Ponatinib was studied for effects on embryo-fetal development in pregnant rats given oral doses of 0.3 mg/kg/day, 1 mg/kg/day, and 3 mg/kg/day during organogenesis (25 r…”

Reproductive / fertility toxicity
4 passages in the label

“…of reproductive potential of the potential for reduced fertility from ICLUSIG [see (8.3) , (13.1) ] . Instructions for Taking ICLUSIG Advise patients to take ICLUSIG exactly as pre…”

2 more passages

“…for 1 week after the last dose [see (8.2) ] . Infertility Advise females of reproductive potential of the potential for reduced fertility from ICLUSIG [see (8.3) , (13.1) ]…”

Animal study“…Females Based on animal data, ponatinib may impair fertility in females of reproductive potential [see (13.1) ] . It is not known whether these effects on fertility are reversibl…”

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

“…THROMBOEMBOLIC EVENTS, HEART FAILURE, and HEPATOTOXICITY WARNING: ARTERIAL OCCLUSIVE EVENTS, VENOUS THROMBOEMBOLIC EVENTS, HEART FAILURE, and HEPATOTOXICITY See full prescri…”

2 more passages

“…THROMBOEMBOLIC EVENTS, HEART FAILURE, and HEPATOTOXICITY See full prescribing information for complete boxed warning. Arterial occlusive events (AOEs), including fatalities,…”

“…new or worsening heart failure. ( 2.2 , 5.3 ) Hepatotoxicity, liver failure and death have occurred in ICLUSIG-treated patients. Monitor liver function tests. Interrupt or disco…”

Set aside: found but not counted (5)
Supporting onlyCarcinogenicity: “OAT1 and OAT3. 13 13.1 In a 2 year carcinogenicity study, male and female rats were administered daily oral doses of ponatinib of 0.05 mg/kg/day, 0.1 mg/kg/day, 0.2”
NegatedGenotoxicity / mutagenicity: “in females at 0.8 mg/kg/day. Ponatinib was not mutagenic in a bacterial mutagenesis (Ames) assay, was not clastogenic in a chromosome aberration assay in human lymphocytes, n”
NegatedGenotoxicity / mutagenicity: “Ponatinib was not mutagenic in a bacterial mutagenesis (Ames) assay, was not clastogenic in a chromosome aberration assay in human lymphocytes, nor was it clastogenic in”
NegatedGenotoxicity / mutagenicity: “a bacterial mutagenesis (Ames) assay, was not clastogenic in a chromosome aberration assay in human lymphocytes, nor was it clastogenic in an in vivo mouse micronucleus assay”
NegatedGenotoxicity / mutagenicity: “(Ames) assay, was not clastogenic in a chromosome aberration assay in human lymphocytes, nor was it clastogenic in an in vivo mouse micronucleus assay at oral doses up to 2000 mg/k”
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.