Screening report

Array BioPharma Inc. · Package insert of record

BRAFTOVI (ENCORAFENIB)

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.
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
16 passages in the label

“…or cetuximab. ( 5.10 ) 5.1 New Primary Malignancies New primary malignancies, cutaneous and noncutaneous, have been observed in patients treated with BRAF inhibitors and c…”

2 more passages

“…5.10 ) 5.1 New Primary Malignancies New primary malignancies, cutaneous and noncutaneous, have been observed in patients treated with BRAF inhibitors and can occur with BRAFTOVI. C…”

“…and can occur with BRAFTOVI. Cutaneous Malignancies In COLUMBUS, cutaneous squamous cell carcinoma (cuSCC), including keratoacanthoma (KA), occurred in 2.6%, and basal cel…”

Developmental / embryo-fetal toxicity
15 passages in the label

“…for QTc of 500 ms or greater. ( 5.7 ) • Embryo-Fetal Toxicity : Can cause fetal harm. Advise females with reproductive potential of potential risk to the fetus and to use e…”

2 more passages

“…(2.5) , Adverse Reactions (6.1) ] . 5.8 Embryo-Fetal Toxicity Based on its mechanism of action, BRAFTOVI can cause fetal harm when administered to a pregnant woman. Encoraf…”

“…syncope [see Warnings and Precautions (5.7) ] . Embryo-Fetal Toxicity • Advise females with reproductive potential of the potential risk to a fetus. Advise females to contact their…”

Reproductive / fertility toxicity
5 passages in the label

“…Males of Reproductive Potential : BRAFTOVI may impair fertility. ( 8.3 ) 8.1 Pregnancy Risk Summary Based on its mechanism of action, BRAFTOVI can cause fetal harm when administered t…”

2 more passages

“…of reproductive potential that BRAFTOVI may impair fertility [see (8.3) ] . Drug Interactions Coadministration of BRAFTOVI with a strong or moderate CYP3A inhibitor may increase…”

“…2 weeks after the last dose [see (8.2) ] . Infertility Advise males of reproductive potential that BRAFTOVI may impair fertility [see (8.3) ] . Drug Interactions Coadminist…”

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

“…Malignancies Permanently discontinue BRAFTOVI. Cardiomyopathy [see Warnings and Precautions (5.3) ] • Symptomatic congestive heart failure or absolute decrease in LVEF of greater th…”

2 more passages

“…can occur with BRAF inhibitors. ( 5.2 ) • Cardiomyopathy : Assess left ventricular ejection fraction (LVEF) before initiating treatment with BRAFTOVI and binimetinib, and after…”

“…(1) , Dosage and Administration (2.1) ] . 5.3 Cardiomyopathy Cardiomyopathy, manifesting as left ventricular dysfunction associated with symptomatic or asymptomatic decreases in ej…”

Drug-class hint
Context only · not counted

“…of systemic therapy in the metastatic setting (platinum-based chemotherapy and/or anti-PD-1/PD-L1 therapies), age 18 years or older, Eastern Cooperative Oncology Group (ECOG) perfor…”

Set aside: found but not counted (3)
NegatedCarcinogenicity: “relevant plasma concentrations. 13 13.1 Carcinogenicity studies with encorafenib have not been conducted. Encorafenib was not genotoxic in studies evaluating reverse muta”
NegatedGenotoxicity / mutagenicity: “have not been conducted. Encorafenib was not genotoxic in studies evaluating reverse mutations in bacteria, chromosomal aberrations in mammalian cells, or micronuclei in bo”
NegatedGenotoxicity / mutagenicity: “evaluating reverse mutations in bacteria, chromosomal aberrations in mammalian cells, or micronuclei in bone marrow of rats. No dedicated fertility studies were performed with encorafe”
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.