Screening report

Kura Oncology, Inc. · Package insert of record

Komzifti (ZIFTOMENIB)

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.
2 / 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: not found
Developmental / embryo-fetal toxicity
17 passages in the label

“…if the QTc interval is > 500 ms. ( 5.2 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of reproductive potential of the potential risk to a fetus and to use e…”

2 more passages

“…( 7.1 ), Clinical Pharmacology ( 12.2 )] . 5.3 Embryo-Fetal Toxicity Based on findings in animals and its mechanism of action, KOMZIFTI can cause embryo-fetal harm when administer…”

“…and its mechanism of action, KOMZIFTI can cause embryo-fetal harm when administered to a pregnant woman. In animal reproduction studies, oral administration of ziftomenib to pregna…”

Reproductive / fertility toxicity
2 passages in the label
Animal data

“…Based on findings in animals, KOMZIFTI may impair fertility in females and males of reproductive potential. Findings in animals were not reversible after a 4-week recovery period…”

1 more passage

“…KOMZIFTI and for 3 months after the last dose. Infertility Based on findings in animals, KOMZIFTI may impair fertility in females and males of reproductive potential. Findings in…”

Set aside: found but not counted (6)
NegatedCarcinogenicity: “OATP1B1, OATP1B3, BSEP, or MRP2. 13 13.1 Carcinogenicity studies have not been conducted with ziftomenib. In a repeat dose toxicity study in mice treated with ziftomenib f”
Supporting onlyCarcinogenicity: “interaction by ziftomenib blocks oncogenic activity of mutant NPM1, which induces differentiation of leukemic cells as evidenced by increased expression of differ”
NegatedGenotoxicity / mutagenicity: “organs in one animal. Ziftomenib was not mutagenic in an in vitro bacterial reverse mutation assay and was not genotoxic in an in vitro micronucleus assay or in an in v”
NegatedGenotoxicity / mutagenicity: “bacterial reverse mutation assay and was not genotoxic in an in vitro micronucleus assay or in an in vivo mouse bone marrow micronucleus assay. Fertility studies in animals”
NegatedGenotoxicity / mutagenicity: “assay and was not genotoxic in an in vitro micronucleus assay or in an in vivo mouse bone marrow micronucleus assay. Fertility studies in animals have not been conducted with”
NegatedGenotoxicity / mutagenicity: “assay or in an in vivo mouse bone marrow micronucleus assay. Fertility studies in animals have not been conducted with ziftomenib. In a repeat dose, 13-week toxicity study i”
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.