Screening report

Eli Lilly and Company · Package insert of record

RETEVMO (selpercatinib)

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: present in the label
Developmental: present in the label
Reproductive: present in the label
Genotoxicity: not found
Organ toxicity: present in the label
Carcinogenicity
1 passage in the label

“…chimeric RET fusion proteins that can act as oncogenic drivers by promoting cell proliferation of tumor cell lines. In in vitro and in vivo tumor models, selpercatinib demons…”

Developmental / embryo-fetal toxicity
19 passages in the label

“…discontinue based on severity. ( 5.9 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the possible risk to a fetus and to use eff…”

2 more passages

“…[see Dosage and Administration ( 2.5 )] . 5.10 Embryo-Fetal Toxicity Based on data from animal reproduction studies and its mechanism of action, RETEVMO can cause fetal harm when…”

“…[see Warnings and Precautions ( 5.11 )] . Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the possible risk to a fetus. Advise females of…”

Reproductive / fertility toxicity
4 passages in the label

“…after the last dose. Infertility RETEVMO may impair fertility in females and males of reproductive potential [see ( 8.4 ), ( 13.1 )] . 8.4 Pediatric Use The safety and effective…”

2 more passages

“…of reproductive potential that RETEVMO may impair fertility [see ( 8.3 ), ( 13.1 )] . Drug Interactions Advise patients and caregivers to inform their healthcare provider of a…”

“…RETEVMO and for 1 week after the last dose. Infertility RETEVMO may impair fertility in females and males of reproductive potential [see ( 8.4 ), ( 13.1 )] . 8.4 Pediatric…”

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

“…Adverse Reaction Severity Dosage Modification Hepatotoxicity [see Warnings and Precautions ( 5.1 )] Grade 3 or Grade 4 Withhold RETEVMO and monitor AST/ALT once weekly until res…”

2 more passages

“…None. None. ( 4 ) 5 WARNINGS AND PRECAUTIONS Hepatotoxicity: Monitor ALT and AST prior to initiating RETEVMO, every 2 weeks during the first 3 months, then monthly thereafter a…”

“…and surgically appropriate ( 5.11 , 6.1 ) 5.1 Hepatotoxicity Serious hepatic adverse reactions occurred in 4.6% of patients treated with RETEVMO. Increased AST occurred in 62% o…”

Drug-class hint
Context only · not counted

“…RET fusion-positive NSCLC who had progressed on platinum-based chemotherapy and patients with locally advanced (stage III who were not candidates for surgical resection or definitive…”

Set aside: found but not counted (6)
NegatedCarcinogenicity: “or MATE2-K. 13 13.1 Selpercatinib was not carcinogenic in a 2-year study in rats when administered by daily oral gavage at doses up to 20 mg/kg in males or 40 mg/kg in fema”
NegatedCarcinogenicity: “daily clinical dose). Selpercatinib was not carcinogenic in a 6-month study in rasH2 transgenic mice when administered by daily oral gavage at doses of up to 60 mg/kg. Selper”
NegatedGenotoxicity / mutagenicity: “doses of up to 60 mg/kg. Selpercatinib was not mutagenic in the in vitro bacterial reverse mutation (Ames) assays, with or without metabolic activation, or clastogenic in the”
NegatedGenotoxicity / mutagenicity: “with or without metabolic activation, or clastogenic in the in vitro micronucleus assay in human peripheral lymphocytes, with or without metabolic activation. Selpercatin”
NegatedGenotoxicity / mutagenicity: “activation, or clastogenic in the in vitro micronucleus assay in human peripheral lymphocytes, with or without metabolic activation. Selpercatinib was positive in the in vivo”
Supporting onlyGenotoxicity / mutagenicity: “Selpercatinib was positive in the in vivo micronucleus assay in rats at concentrations >7 times the C max at the human dose of 160 mg twice daily. In general toxicology studi”
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.