Screening report

Genentech, Inc. · Package insert of record

Rozlytrek (ENTRECTINIB)

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
19 passages in the label

“…improvement or stabilization. ( 2.7 , 5.7 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of e…”

2 more passages

“…[see Dosage and Administration (2.7) ] . 5.8 Embryo-Fetal Toxicity Based on literature reports in humans with congenital mutations leading to changes in TRK signaling, findings…”

“…(8.1) ] . Contraception ROZLYTREK can cause embryo-fetal harm when administered to a pregnant woman [see (8.1) ]. Females Advise female patients of reproductive potential to…”

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

“…Grade 4 Permanently discontinue ROZLYTREK. Hepatotoxicity [see Warnings and Precautions (5.4) ] Grade 3 Withhold ROZLYTREK until recovery to less than or equal to Grade 1 or…”

2 more passages

“…with signs or symptoms of fractures. ( 5.3 ) Hepatotoxicity : Monitor liver tests, including ALT and AST, every 2 weeks during the first month of treatment, then monthly therea…”

“…fractures and risk of future fractures. 5.4 Hepatotoxicity Among the 355 patients who received ROZLYTREK, increased AST of any grade occurred in 42% of patients and increased…”

Drug-class hint
Context only · not counted

“…96% had adenocarcinoma; 65% received prior platinum-based chemotherapy for metastatic or recurrent disease and no patient had progressed in less than 6 months following platinum…”

Set aside: found but not counted (9)
NegatedCarcinogenicity: “substrates of OATP1B1 or OATP1B3. 13 13.1 Carcinogenicity studies were not conducted with entrectinib. Entrectinib was not mutagenic in vitro in the bacterial reverse mutat”
Supporting onlyCarcinogenicity: “TRK, ROS1, or ALK kinase domains can drive tumorigenic potential through hyperactivation of downstream signaling pathways leading to unconstrained cell proliferation. Entre”
NegatedGenotoxicity / mutagenicity: “conducted with entrectinib. Entrectinib was not mutagenic in vitro in the bacterial reverse mutation (Ames) assay; however, an in vitro assay in cultured human peripheral bloo”
NegatedGenotoxicity / mutagenicity: “segregation (aneugenicity). Entrectinib was not clastogenic or aneugenic in the in vivo micronucleus assay in rats and did not induce DNA damage in a comet assay in rats. Dedica”
NegatedGenotoxicity / mutagenicity: “was not clastogenic or aneugenic in the in vivo micronucleus assay in rats and did not induce DNA damage in a comet assay in rats. Dedicated fertility studies were not conducted wi”
NegatedGenotoxicity / mutagenicity: “micronucleus assay in rats and did not induce DNA damage in a comet assay in rats. Dedicated fertility studies were not conducted with entrectinib. With the exception of dose-d”
NegatedGenotoxicity / mutagenicity: “Entrectinib was not clastogenic or aneugenic in the in vivo micronucleus assay in rats and did not induce DNA damage in a comet assay in rats. Dedicated fertility”
Supporting onlyGenotoxicity / mutagenicity: “potential for abnormal chromosome segregation (aneugenicity). Entrectinib was not clastogenic or aneugenic in the in vivo micronucleus assay in rats and did not induce DNA da”
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.