Screening report

Exelixis, Inc. · Package insert of record

CABOMETYX (CABOZANTINIB)

NIOSH Table 2DailyMed (opens the full label on DailyMed in a new tab)
On the NIOSH List — Table 2
This drug appears on the NIOSH List of Hazardous Drugs, 2024 (Table 2).
4 / 6NIOSH hazard criteria present in this label
Special handling: not found
Carcinogenicity: present in the label
Developmental: present in the label
Reproductive: present in the label
Genotoxicity: not found
Organ toxicity: present in the label
Carcinogenicity
2 passages in the label
Animal data

“…mice and Sprague-Dawley rats. In the 2-year rat carcinogenicity study, once daily oral administration of cabozantinib resulted in a statistically significant increase in the inci…”

1 more passage

“…of this finding is unknown. 13 13.1 The carcinogenic potential of cabozantinib has been evaluated in two species: rasH2 transgenic mice and Sprague-Dawley rats. In the 2-…”

Developmental / embryo-fetal toxicity
20 passages in the label

“…CABOMETYX depending on severity. ( 5.15 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use ef…”

2 more passages

“…[see Dosage and Administration (2.3) ] . 5.16 Embryo-Fetal Toxicity Based on data from animal studies and its mechanism of action, CABOMETYX can cause fetal harm when administere…”

“…risk to a fetus. Data Animal Data In an embryo-fetal development study in pregnant rats, daily oral administration of cabozantinib throughout organogenesis caused increased…”

Reproductive / fertility toxicity
2 passages in the label
Animal data

“…Based on findings in animals, CABOMETYX may impair fertility in females and males of reproductive potential [see (13.1) ] . 8.4 Pediatric Use The safety and effectiveness of CABO…”

1 more passage

“…and for 4 months after the final dose. Infertility Females and Males Based on findings in animals, CABOMETYX may impair fertility in females and males of reproductive pot…”

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

“…PPE resolves or decreases to Grade 1. ( 5.7 ) Hepatotoxicity: When used in combination with nivolumab, higher frequencies of Grade 3 and 4 ALT and AST elevation may occur than w…”

2 more passages

“…the combination for severe or life- threatening hepatotoxicity. ( 5.8 ) Adrenal Insufficiency: When used in combination with nivolumab, primary or secondary adrenal insufficiency…”

“…[see Dosage and Administration (2.3) ] . 5.8 Hepatotoxicity CABOMETYX in combination with nivolumab can cause hepatic toxicity with higher frequencies of Grades 3 and 4 ALT and…”

Set aside: found but not counted (5)
NegatedCarcinogenicity: “recommended 60 mg dose). Cabozantinib was not carcinogenic in a 26-week carcinogenicity study in rasH2 transgenic mice at a slightly higher exposure than the intended human the”
NegatedCarcinogenicity: “Cabozantinib was not carcinogenic in a 26-week carcinogenicity study in rasH2 transgenic mice at a slightly higher exposure than the intended human therapeutic exposure. Cabozan”
NegatedGenotoxicity / mutagenicity: “therapeutic exposure. Cabozantinib was not mutagenic in vitro in the bacterial reverse mutation (Ames) assay and was not clastogenic in both the in vitro cytogenetic assa”
NegatedGenotoxicity / mutagenicity: “reverse mutation (Ames) assay and was not clastogenic in both the in vitro cytogenetic assay using human lymphocytes or in the in vivo mouse micronucleus assay. Based on n”
NegatedGenotoxicity / mutagenicity: “using human lymphocytes or in the in vivo mouse micronucleus assay. Based on nonclinical findings, male and female fertility may be impaired by treatment with CABOMETYX. In a ferti”
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.