Screening report

Daiichi Sankyo Inc. · Package insert of record

VANFLYTA (QUIZARTINIB)

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: not found
Developmental: present in the label
Reproductive: present in the label
Genotoxicity: present in the label
Organ toxicity: not found
Genotoxicity / mutagenicity
2 passages in the label

“…7 months after the last dose. Males Based on genotoxicity findings, advise male patients with female partners of reproductive potential to use effective contraception durin…”

1 more passage

“…assays, or in an in vivo rat bone marrow micronucleus assay. Fertility studies in animals have not been conducted with quizartinib. However, adverse findings in male and fem…”

Developmental / embryo-fetal toxicity
16 passages in the label

“…VANFLYTA as appropriate. ( 2.3 , 5.1 ) Embryo-Fetal Toxicity: VANFLYTA can cause fetal harm. Advise females of reproductive potential and males with female partners of rep…”

2 more passages

“…or by telephone at 1-855-212-6670. 5.3 Embryo-Fetal Toxicity Based on findings in animals and its mechanism of action, VANFLYTA can cause fetal harm when administered to a…”

“…and its mechanism of action, VANFLYTA can cause embryo-fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on VANFLYT…”

Reproductive / fertility toxicity
4 passages in the label

“…of reproductive potential that VANFLYTA may impair fertility [see (8.3) and (13.1) ] . Lactation Advise women not to breastfeed during treatment with VANFLYTA and for one month…”

2 more passages

“…and Precautions (5.3) and (8.1 , 8.3) ]. Infertility Advise females and males of reproductive potential that VANFLYTA may impair fertility [see (8.3) and (13.1) ] . Lac…”

Animal study“…release, germ cell depletion in the testes, and oligospermia/aspermia, starting at exposures approximately 0.4 times the MRHD. After approximately one month of recovery period, all…”

Set aside: found but not counted (6)
NegatedCarcinogenicity: “BCRP at the recommended dosage. 13 13.1 Carcinogenicity studies have not been conducted with quizartinib. Quizartinib was mutagenic in a bacterial reverse mutation (Ames)”
Supporting onlyCarcinogenicity: “of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test [see Dosage and Admin”
NegatedGenotoxicity / mutagenicity: “conducted with quizartinib. Quizartinib was mutagenic in a bacterial reverse mutation (Ames) assay and not mutagenic in an in vivo transgenic rat mutation assay. Quizartin”
NegatedGenotoxicity / mutagenicity: “bacterial reverse mutation (Ames) assay and not mutagenic in an in vivo transgenic rat mutation assay. Quizartinib was not genotoxic in vitro in mouse lymphoma thymidine kinas”
NegatedGenotoxicity / mutagenicity: “rat mutation assay. Quizartinib was not genotoxic in vitro in mouse lymphoma thymidine kinase mutation and human lymphocyte chromosome aberration assays, or in an in v”
NegatedGenotoxicity / mutagenicity: “thymidine kinase mutation and human lymphocyte chromosome aberration assays, or in an in vivo rat bone marrow micronucleus assay. Fertility studies in animals have not been conducted with”
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.