Screening report

Janssen Biotech, Inc. · Package insert of record

LAZCLUZE (LAZERTINIB)

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
20 passages in the label

“…continue LAZCLUZE based on severity. ( 5.5 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise patients of reproductive potential of the potential risk to a fetus and to use…”

2 more passages

“…[see Dosage and Administration (2.4) ] . 5.6 Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, LAZCLUZE can cause fetal harm when administ…”

“…the period of organogenesis resulted in reduced embryo-fetal survival and fetal body weight in rats and malformations in rabbits at exposures approximately 4 and 0.5 times, respect…”

Reproductive / fertility toxicity
4 passages in the label

“…potential of the potential risk for impaired fertility with LAZCLUZE [see (13.1) ] . Product of Belgium Manufactured for: Janssen Biotech, Inc. Horsham, PA 19044, USA For p…”

2 more passages

“…information during treatment with amivantamab. Infertility Advise males and females of reproductive potential of the potential risk for impaired fertility with LAZCLUZE [see (1…”

Animal study“…Based on findings in animals, LAZCLUZE may impair fertility in females and males of reproductive potential. The effects on female fertility were reversible. The effects on male te…”

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

“…at the discretion of the healthcare provider. Hepatotoxicity [see Warnings and Precautions (5.4) ] Grade 3-4 Withhold LAZCLUZE and amivantamab until the adverse reaction resolve…”

2 more passages

“…based on severity. ( 2.3 , 2.4 , 5.3 ) Hepatotoxicity : Can cause severe hepatotoxicity (including increased ALT and AST). Withhold, reduce the dose, or permanently disco…”

“…, 2.4 , 5.3 ) Hepatotoxicity : Can cause severe hepatotoxicity (including increased ALT and AST). Withhold, reduce the dose, or permanently discontinue LAZCLUZE and amivantamab ba…”

Set aside: found but not counted (4)
NegatedCarcinogenicity: “induce CYP1A2, CYP2B6 and CYP3A4. 13 13.1 Carcinogenicity studies have not been conducted with lazertinib. Lazertinib was not genotoxic in an in vitro bacterial reverse mut”
NegatedGenotoxicity / mutagenicity: “conducted with lazertinib. Lazertinib was not genotoxic in an in vitro bacterial reverse mutation (Ames) assay, an in vitro chromosomal aberration assay, or an in vivo micro”
NegatedGenotoxicity / mutagenicity: “reverse mutation (Ames) assay, an in vitro chromosomal aberration assay, or an in vivo micronucleus assay in rats. In a dedicated fertility and early embryonic development study, male a”
NegatedGenotoxicity / mutagenicity: “chromosomal aberration assay, or an in vivo micronucleus assay in rats. In a dedicated fertility and early embryonic development study, male and female rats received oral doses”
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.