Screening report

Takeda Pharmaceuticals America, Inc. · Package insert of record

Fruzaqla (FRUQUINTINIB)

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
19 passages in the label

“…during the period of organogenesis resulted in teratogenicity and embryo lethality at exposures below the clinical exposure (see Data ) . There are no data on the use of FRUZAQ…”

2 more passages

“…in certain susceptible patients. ( 5.11 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of reproductive potential of the potential risk to the fetus and to use…”

“…FCF), which may cause allergic reactions. 5.12. Embryo-Fetal Toxicity Based on findings in animal studies and its mechanism of action, FRUZAQLA can cause fetal harm when administer…”

Reproductive / fertility toxicity
2 passages in the label

“…and Precautions (5.11) and (13.1) ] . Infertility Females and Males There are no data on the effects of fruquintinib on human fertility. Based on findings in animal stud…”

1 more passage

“…the last dose of FRUZAQLA [see (8.2) ] . Infertility Advise females of reproductive potential that FRUZAQLA may cause post-implantation loss [see (8.3) , (13.1) ] . Dis…”

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

“…3 or Grade 4 Permanently discontinue FRUZAQLA. Hepatotoxicity [see Warnings and Precautions (5.5) ] Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater tha…”

2 more passages

“…who develop GI perforation or fistula. ( 5.4 ) Hepatotoxicity: Monitor liver laboratory tests prior to the start of FRUZAQLA and periodically during treatment. Withhold, reduce t…”

“…gastrointestinal perforation or fistula. 5.5. Hepatotoxicity FRUZAQLA can cause liver injury. In 911 patients with mCRC treated with FRUZAQLA, 48% experienced increased ALT or A…”

Set aside: found but not counted (6)
NegatedCarcinogenicity: “protein (MATE)1, or MATE2-K. 13. 13.1. Carcinogenicity studies have not been conducted with fruquintinib. Fruquintinib was not mutagenic in the in vitro bacterial revers”
NegatedGenotoxicity / mutagenicity: “with fruquintinib. Fruquintinib was not mutagenic in the in vitro bacterial reverse mutation (Ames) assay or clastogenic in the in vitro Chinese hamster ovary chromoso”
NegatedGenotoxicity / mutagenicity: “aberration assay. Fruquintinib was not genotoxic in the in vivo rat micronucleus or alkaline comet assays. In a fertility and early embryonic development study in rat”
NegatedGenotoxicity / mutagenicity: “bacterial reverse mutation (Ames) assay or clastogenic in the in vitro Chinese hamster ovary chromosome aberration assay. Fruquintinib was not genotoxic in the in vivo rat”
NegatedGenotoxicity / mutagenicity: “in the in vitro Chinese hamster ovary chromosome aberration assay. Fruquintinib was not genotoxic in the in vivo rat micronucleus or alkaline comet assays. In a fertility and earl”
NegatedGenotoxicity / mutagenicity: “was not genotoxic in the in vivo rat micronucleus or alkaline comet assays. In a fertility and early embryonic development study in rats, post-implantation loss was obse”
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.