FOTIVDA (Tivozanib): 2 of 6 NIOSH criteria in the label

Screening report

AVEO Pharmaceuticals, Inc. · Package insert of record

FOTIVDA (Tivozanib)

Not on the NIOSH ListDailyMed

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

Carcinogenicity

Developmental

Reproductive

Genotoxicity

Organ toxicity

Developmental / embryo-fetal toxicity

26 passages in the label

“…if signs or symptoms of RPLS occur. ( 5.10 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. (…”

2 more passages

“…[see DOSAGE AND ADMINISTRATION (2.2) ] . 5.11 Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, FOTIVDA can cause fetal harm when administe…”

“…harm when administered to a pregnant woman. In embryo-fetal developmental studies, oral administration of tivozanib to pregnant animals during the period of organogenesis caused m…”

Reproductive / fertility toxicity

6 passages in the label

“…and Males of Reproductive Potential: Can impair fertility. ( 8.3 ) Hepatic Impairment: Adjust dosage in patients with moderate hepatic impairment. Avoid use in patients with sev…”

2 more passages

“…of reproductive potential that FOTIVDA can impair fertility [see (8.3) ] . Allergic Reactions to Tartrazine (FD&C Yellow No.5) FOTIVDA 0.89 mg capsule contains FD&C Yellow No.5…”

“…one month after the last dose [see (8.2) ]. Infertility Advise males and females of reproductive potential that FOTIVDA can impair fertility [see (8.3) ] . Allergic Reaction…”

Set aside: found but not counted (4)

NegatedCarcinogenicity: “OCT1, OATP1B1, OATP1B3, or BSEP. 13 13.1 Carcinogenicity studies have not been conducted with tivozanib. Tivozanib was not mutagenic in a bacterial reverse mutation (Ames)”

NegatedGenotoxicity / mutagenicity: “conducted with tivozanib. Tivozanib was not mutagenic in a bacterial reverse mutation (Ames) assay and was not clastogenic in an in vitro cytogenetic assay in Chinese hams”

NegatedGenotoxicity / mutagenicity: “reverse mutation (Ames) assay and was not clastogenic in an in vitro cytogenetic assay in Chinese hamster ovary cells or in an in vivo mouse bone marrow micronucleus assay”

NegatedGenotoxicity / mutagenicity: “ovary cells or in an in vivo mouse bone marrow micronucleus assay. In animal studies assessing mating and fertility parameters, oral doses ≥ 0.03 mg/kg/day (0.2 times the maximum”

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.