Screening report

Xcovery Holdings, Inc. · Package insert of record

ENSACOVE (ENSARTINIB)

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.
2 / 6NIOSH hazard criteria present in this label
Special handling: not found
Carcinogenicity: not found
Developmental: present in the label
Reproductive: not found
Genotoxicity: not found
Organ toxicity: present in the label
Developmental / embryo-fetal toxicity
20 passages in the label

“…discontinue ENSACOVE based on severity. ( 5.8 ) 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 ( 2.4 )]. 5.9 Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, ENSACOVE can cause fetal harm when administ…”

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

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

“…)] Any Grade Permanently discontinue ENSACOVE. Hepatotoxicity [see Warnings and Precautions ( 5.2 )] Grade 3 or 4 elevation (greater than 5 times ULN) of either ALT or AST with c…”

2 more passages

“…in patients with ILD/pneumonitis. ( 5.1 ) Hepatotoxicity : Monitor liver function tests during treatment with ENSACOVE. Withhold, reduce the dose, or permanently discontinue…”

“…[see Dosage and Administration ( 2.4 )]. 5.2 Hepatotoxicity ENSACOVE can cause hepatotoxicity including drug-induced liver injury. In the pooled safety population [see Adverse…”

Set aside: found but not counted (5)
NegatedCarcinogenicity: “OAT1, OAT3, OCT1, OCT2 or OCT3. 13 13.1 Carcinogenicity studies have not been conducted with ensartinib. Ensartinib was not mutagenic in a bacterial reverse mutation (Ame”
NegatedGenotoxicity / mutagenicity: “conducted with ensartinib. Ensartinib was not mutagenic in a bacterial reverse mutation (Ames) assay and was not clastogenic in an in vitro human lymphocyte chromosome aberr”
NegatedGenotoxicity / mutagenicity: “reverse mutation (Ames) assay and was not clastogenic in an in vitro human lymphocyte chromosome aberration assay or an in vivo rat bone marrow micronucleus assay. Dedicat”
NegatedGenotoxicity / mutagenicity: “not clastogenic in an in vitro human lymphocyte chromosome aberration assay or an in vivo rat bone marrow micronucleus assay. Dedicated fertility studies were not conducted with ensartinib.”
NegatedGenotoxicity / mutagenicity: “aberration assay or an in vivo rat bone marrow micronucleus assay. Dedicated fertility studies were not conducted with ensartinib. No adverse effects on male or female reproductiv”
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.