Screening report

Deciphera Pharmaceuticals, LLC · Package insert of record

ROMVIMZA (VIMSELTINIB)

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
16 passages in the label

“…treatment and during treatment. ( 2.2 , 5.1 ) 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

“…[see Dosage and Administration ( 2.2 )] . 5.2 Embryo-Fetal Toxicity Based on data from animal studies and its mechanism of action, ROMVIMZA can cause fetal harm when administered…”

“…to a fetus. Data Animal Data In a rat embryo-fetal development study, pregnant female rats were dosed once daily during the period of organogenesis (gestational days 6 to…”

Reproductive / fertility toxicity
5 passages in the label

“…. Infertility Advise patients that ROMVIMZA may impair fertility [see ( 8.3 ), ( 13.1 )] . Allergic Reactions to FD&C Yellow No. 5 (Tartrazine) and No. 6 (Sunset Yellow FCF) Advise…”

2 more passages

“…1 month after the final dose [see ( 8.2 )] . Infertility Advise patients that ROMVIMZA may impair fertility [see ( 8.3 ), ( 13.1 )] . Allergic Reactions to FD&C Yellow No.…”

Animal study“…on findings from animal studies, ROMVIMZA may impair fertility [see ( 13.1 )] . 8.4 Pediatric Use The safety and effectiveness of ROMVIMZA in pediatric patients have not been estab…”

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

“…information for dosage modifications due to hepatotoxicity and drug interactions. ( 2.2 , 2.3 ) 2.1 Recommended Dosage The recommended dosage of ROMVIMZA is 30 mg orally taken…”

2 more passages

“…The recommended dosage modifications for hepatotoxicity are summarized in Table 2 . Table 2: Recommended Dosage Modifications for Hepatotoxicity Hepatotoxicity Severity ROM…”

“…. Table 2: Recommended Dosage Modifications for Hepatotoxicity Hepatotoxicity Severity ROMVIMZA Dosage Modifications ALT = alanine aminotransferase; ALP = alkaline phosphatase; AS…”

Set aside: found but not counted (8)
NegatedCarcinogenicity: “13 13.1 In a 6-month transgenic mouse carcinogenicity study at doses up to 12.5 mg/kg/day, vimseltinib was negative for carcinogenic findings. In a 2-year rat carcinoge”
NegatedCarcinogenicity: “to 12.5 mg/kg/day, vimseltinib was negative for carcinogenic findings. In a 2-year rat carcinogenicity study, female rats were orally administered vimseltinib at doses of 0.15, 0”
NegatedCarcinogenicity: “on AUC). The relevance of this finding to human carcinogenic risk is not known. In male rats receiving 1.0 mg/kg/day, two out of sixty rats were identified as having sarcomas in”
NegatedCarcinogenicity: “significant and its relevance to human carcinogenic risk is not known. Vimseltinib was not mutagenic in the bacterial reverse mutation assay (Ames). In an in vitro micro”
Supporting onlyCarcinogenicity: “for carcinogenic findings. In a 2-year rat carcinogenicity study, female rats were orally administered vimseltinib at doses of 0.15, 0.45, or 1.5 mg/kg/day. There was no evi”
NegatedGenotoxicity / mutagenicity: “risk is not known. Vimseltinib was not mutagenic in the bacterial reverse mutation assay (Ames). In an in vitro micronucleus assay, vimseltinib increased micronuclei”
NegatedGenotoxicity / mutagenicity: “reverse mutation assay (Ames). In an in vitro micronucleus assay, vimseltinib increased micronuclei after a 24 -hour incubation in the absence of metabolic activation. In vivo, v”
NegatedDevelopmental / embryo-fetal toxicity: “to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In female rats administered vimseltinib during the period of orga”
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.