Screening report

Verastem Inc. · Package insert of record

AVMAPKI FAKZYNJA CO-PACK (AVUTOMETINIB POTASSIUM AND DEFACTINIB HYDROCHLORIDE)

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: not found
Developmental: present in the label
Reproductive: present in the label
Genotoxicity: present in the label
Organ toxicity: present in the label
Genotoxicity / mutagenicity
3 passages in the label
Animal data

“…in the in vitro micronucleus assay through an aneugenic mechanism and in the in vivo rat bone marrow micronucleus assay. Dedicated fertility studies have not been conducte…”

2 more passages

“…assay. Defactinib was positive in the in vitro micronucleus assay through an aneugenic mechanism and in the in vivo rat bone marrow micronucleus assay. Dedicated fertility studi…”

“…mechanism and in the in vivo rat bone marrow micronucleus assay. Dedicated fertility studies have not been conducted with defactinib. In male rats administered defactinib for…”

Developmental / embryo-fetal toxicity
13 passages in the label

“…duration of the adverse reaction. ( 2.4 , 5.4 ) Embryo-Fetal Toxicity : AVMAPKI FAKZYNJA CO-PACK can cause fetal harm. Advise patients of the potential risk to a fetus and to use e…”

2 more passages

“…reactions [see Dose Modifications (2.4) ] . 5.5 Embryo-Fetal Toxicity Based on the mechanisms of action, AVMAPKI FAKZYNJA CO-PACK can cause fetal harm when administered to a pregna…”

“…acting antacid [see Drug Interactions (7.1) ] . Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females t…”

Reproductive / fertility toxicity
6 passages in the label

“…not to breastfeed. ( 8.2 ) Infertility : May impair fertility in males and females. ( 8.3 ) 8.1 Pregnancy Risk Summary Based on the mechanisms of action, AVMAPKI FAKZYNJA CO-PACK ca…”

2 more passages

“…potential that AVMAPKI FAKZYNJA CO-PACK may impair fertility [see (8.3) ] . Manufactured for and Distributed by: Verastem, Inc. Needham, Massachusetts 02494 1-877-878-6662 © 2025…”

“…Lactation : Advise not to breastfeed. ( 8.2 ) Infertility : May impair fertility in males and females. ( 8.3 ) 8.1 Pregnancy Risk Summary Based on the mechanisms of action, AVMA…”

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

“…discontinue AVMAPKI FAKZYNJA CO-PACK. Hepatotoxicity [see Warnings and Precautions (5.3) ] Grade 2 Withhold AVMAPKI FAKZYNJA CO-PACK for Grade 2 hyperbilirubinemia (with…”

2 more passages

“…tolerability and duration. ( 2.4 , 5.2 ) Hepatotoxicity : Monitor liver function tests prior to each cycle, on day 15 of the first 4 cycles, and as clinically indicated. Wi…”

“…[see Dosage and Administration (2.4) ]. 5.3 Hepatotoxicity AVMAPKI FAKZYNJA CO-PACK can cause hepatotoxicity. In patients with recurrent LGSOC who received AVMAPKI FAKZYNJA CO…”

Drug-class hint
Context only · not counted

“…least one prior systemic therapy, including a platinum-based regimen. KRAS mutation status was determined by prospective local testing using next generation sequencing (NGS) or pol…”

Set aside: found but not counted (12)
NegatedCarcinogenicity: “OAT3, OCT1, and OCT2. 13 13.1 Avutometinib Carcinogenesis Carcinogenicity studies have not been conducted with avutometinib. Mutagenesis Avutometinib was not mutagenic in th”
NegatedCarcinogenicity: “OCT2. 13 13.1 Avutometinib Carcinogenesis Carcinogenicity studies have not been conducted with avutometinib. Mutagenesis Avutometinib was not mutagenic in the bacterial rev”
NegatedCarcinogenicity: “were reversible. Defactinib Carcinogenesis Carcinogenicity studies have not been conducted with defactinib. Mutagenesis Defactinib was not mutagenic in the bacterial reverse”
NegatedGenotoxicity / mutagenicity: “have not been conducted with avutometinib. Mutagenesis Avutometinib was not mutagenic in the bacterial reverse mutagenesis (Ames) assay and was not clastogenic in an in v”
NegatedGenotoxicity / mutagenicity: “avutometinib. Mutagenesis Avutometinib was not mutagenic in the bacterial reverse mutagenesis (Ames) assay and was not clastogenic in an in vitro Chinese hamster lung chromos”
NegatedGenotoxicity / mutagenicity: “was not mutagenic in the bacterial reverse mutagenesis (Ames) assay and was not clastogenic in an in vitro Chinese hamster lung chromosome aberration assay or an in vivo”
NegatedGenotoxicity / mutagenicity: “have not been conducted with defactinib. Mutagenesis Defactinib was not mutagenic in the bacterial reverse mutagenesis (Ames) assay and was not clastogenic in an in vit”
NegatedGenotoxicity / mutagenicity: “reverse mutagenesis (Ames) assay and was not clastogenic in an in vitro Chinese hamster lung chromosome aberration assay or an in vivo rat bone marrow micronucleus assay. D”
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.