TEPMETKO (TEPOTINIB HYDROCHLORIDE): 2 of 6 NIOSH criteria in the label

Screening report

EMD Serono, Inc. · Package insert of record

TEPMETKO (TEPOTINIB HYDROCHLORIDE)

Not on the NIOSH ListDailyMed

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

Carcinogenicity

Developmental

Reproductive

Genotoxicity

Organ toxicity

Developmental / embryo-fetal toxicity

21 passages in the label

“…of organogenesis resulted in malformations (teratogenicity) and anomalies at exposures less than the human exposure based on area under the curve (AUC) at the 450 mg daily c…”

2 more passages

“…of organogenesis resulted in malformations (teratogenicity) and anomalies at maternal exposures less than the human exposure based on area under the curve (AUC) at the 450 m…”

“…discontinue TEPMETKO based on severity. ( 5.3 ) Embryo-fetal toxicity : TEPMETKO can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception. ( 5.4…”

Organ toxicity (verify at low doses)

21 passages in the label

“…ILD/pneumonitis of any severity. ( 2.4 , 5.1 ) Hepatotoxicity : Monitor liver function tests. Withhold, dose reduce, or permanently discontinue TEPMETKO based on severity. ( 5.2…”

2 more passages

“…[see Dosage and Administration (2.4) ]. 5.2 Hepatotoxicity Hepatotoxicity occurred in patients treated with TEPMETKO [see Adverse Reactions (6.1) ] . Increased alanine aminotr…”

“…and Administration (2.4) ]. 5.2 Hepatotoxicity Hepatotoxicity occurred in patients treated with TEPMETKO [see Adverse Reactions (6.1) ] . Increased alanine aminotransferase (ALT)…”

Drug-class hint

Context only · not counted

“…previously treated patients, 84% received prior platinum-based chemotherapy. Efficacy results are presented in Table 4. Table 4: Efficacy Results in the VISION study Efficacy paramet…”

Set aside: found but not counted (7)

NegatedCarcinogenicity: “anion transporter (OAT) 1 and 3. 13 13.1 Carcinogenicity studies have not been performed with tepotinib. Tepotinib and its major circulating metabolite were not mutagenic”

Supporting onlyCarcinogenicity: “In mice implanted with tumor cell lines with oncogenic activation of MET, including MET ex14 skipping alterations, tepotinib inhibited tumor growth, led to sustained inhibiti”

NegatedGenotoxicity / mutagenicity: “and its major circulating metabolite were not mutagenic in vitro in the bacterial reverse mutation (Ames) assay , or a mouse lymphoma assay. In vivo, tepotinib was not genot”

NegatedGenotoxicity / mutagenicity: “lymphoma assay. In vivo, tepotinib was not genotoxic in a rat micronucleus test. Fertility studies of tepotinib have not been performed. There were no morphological chang”

NegatedGenotoxicity / mutagenicity: “In vivo, tepotinib was not genotoxic in a rat micronucleus test. Fertility studies of tepotinib have not been performed. There were no morphological changes in male or female rep”

NegatedOrgan toxicity (verify at low doses): “TEPMETKO in patients with suspected ILD/pneumonitis and permanently discontinue if no other potential causes of ILD/pneumonitis are identified [see Dosage and Administrati”

NegatedOrgan toxicity (verify at low doses): “discontinue if no other potential causes of ILD/pneumonitis are identified [see Dosage and Administration (2.4) ]. 5.2 Hepatotoxicity Hepatotoxicity occurred in patients treated w”

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.