Screening report

Nuvation Bio Inc. · Package insert of record

IBTROZI (taletrectinib)

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
19 passages in the label

“…in mobility, deformity) of fractures. ( 5.6 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. (…”

2 more passages

“…fractures and risk of future fractures. 5.7 Embryo-Fetal Toxicity Based on literature reports in humans with congenital mutations leading to changes in tropomyosin receptor kin…”

“…during the period of organogenesis resulted in embryo-fetal mortalities and structural abnormalities. Findings in both species occurred at doses resulting in exposures below or eq…”

Reproductive / fertility toxicity
2 passages in the label
Animal data

“…Based on findings in animals, IBTROZI may impair fertility in males and females [see 13.1 )]. The effects on animal fertility were reversible. 8.4 Pediatric Use The safety and…”

1 more passage

“…3 weeks after the last dose [see ( 13.1 )] . Infertility Based on findings in animals, IBTROZI may impair fertility in males and females [see 13.1 )]. The effects on animal f…”

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

“…Adverse Reaction Severity* Dosage Modification Hepatotoxicity (Elevation of ALT or AST) [see Warnings and Precautions ( 5.1 )] Grade 3 (>5 - 20 × ULN) Withhold IBTROZI until reco…”

2 more passages

“…None. None ( 4 ) 5 WARNINGS AND PRECAUTIONS Hepatotoxicity: Monitor liver function tests prior to initiating, every 2 weeks during the first 2 months of treatment, then monthl…”

“…and to use effective contraception. ( 5.7 ) 5.1 Hepatotoxicity IBTROZI can cause hepatotoxicity, including drug-induced liver injury and fatal adverse reactions. In the pooled saf…”

Drug-class hint
Context only · not counted

“…adenocarcinoma; and 19% of patients had prior platinum-based chemotherapy for advanced disease. TRUST-II: Among 54 patients with ROS1 TKI-naïve NSCLC treated in TRUST-II, the media…”

Set aside: found but not counted (12)
NegatedCarcinogenicity: “BCRP, OATP1B1, MATE1 and MATE2-K. 13 13.1 Carcinogenesis Carcinogenicity studies with taletrectinib were not conducted. Mutagenesis Taletrectinib was not mutagenic in the i”
NegatedCarcinogenicity: “MATE1 and MATE2-K. 13 13.1 Carcinogenesis Carcinogenicity studies with taletrectinib were not conducted. Mutagenesis Taletrectinib was not mutagenic in the in vitro bacteri”
Supporting onlyCarcinogenicity: “proteins that include ROS1 domains can drive tumorigenic potential through hyperactivation of downstream signaling pathways leading to unconstrained cell proliferation. Talet”
NegatedGenotoxicity / mutagenicity: “studies with taletrectinib were not conducted. Mutagenesis Taletrectinib was not mutagenic in the in vitro bacterial reverse mutation (Ames) assay and additional mutagenicity”
NegatedGenotoxicity / mutagenicity: “conducted. Mutagenesis Taletrectinib was not mutagenic in the in vitro bacterial reverse mutation (Ames) assay and additional mutagenicity tests. Taletrectinib was not clas”
NegatedGenotoxicity / mutagenicity: “reverse mutation (Ames) assay and additional mutagenicity tests. Taletrectinib was not clastogenic or aneugenic in the in vivo micronucleus study in rats in bone marrow and”
NegatedGenotoxicity / mutagenicity: “mutagenicity tests. Taletrectinib was not clastogenic or aneugenic in the in vivo micronucleus study in rats in bone marrow and liver. In a fertility and early embryonic”
NegatedGenotoxicity / mutagenicity: “was not clastogenic or aneugenic in the in vivo micronucleus study in rats in bone marrow and liver. In a fertility and early embryonic development study in rats, male animals we”
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.