Tepotinib is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14 skipping alterations. It is available as tablets for oral use. MedsAcross supplies Tepotinib for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
TEPMETKO is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14 skipping alterations. TEPMETKO is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14 skipping alterations.
Source: US FDA prescribing information
Tepotinib is a kinase inhibitor that targets MET, including variants with exon 14 skipping alterations. Tepotinib inhibits hepatocyte growth factor (HGF)-dependent and -independent MET phosphorylation and MET-dependent downstream signaling pathways. Tepotinib also inhibited melatonin 2 and imidazoline 1 receptors at clinically achievable concentrations. In vitro, tepotinib inhibited tumor cell proliferation, anchorage-independent growth, and migration of MET-dependent tumor cells. In mice implanted with tumor cell lines with oncogenic activation of MET, including MET ex14 skipping alterations, tepotinib inhibited tumor growth, led to sustained inhibition of MET phosphorylation, and, in one model, decreased the formation of metastases.
Source: US FDA prescribing information
Select patients for treatment with TEPMETKO on the presence of MET ex14 skipping. Recommended dosage: 450 mg orally once daily with food until disease progression or unacceptable toxicity.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Interstitial Lung Disease (ILD)/Pneumonitis: Immediately withhold TEPMETKO in patients with suspected ILD/pneumonitis. Permanently discontinue TEPMETKO in patients diagnosed with ILD/pneumonitis of any severity. Hepatotoxicity: Monitor liver function tests. Withhold, dose reduce, or permanently discontinue TEPMETKO based on severity. Pancreatic Toxicity: Monitor amylase and lipase. Embryo-fetal toxicity: TEPMETKO can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception.
Source: US FDA prescribing information
The following adverse reactions are described in greater detail elsewhere in the labeling: Interstitial Lung Disease/Pneumonitis Hepatotoxicity Pancreatic Toxicity Most common adverse reactions (≥ 20%) were edema, nausea, fatigue, musculoskeletal pain, diarrhea, dyspnea, decreased appetite, and rash. The most common Grade 3 to 4 laboratory abnormalities (≥ 2%) were decreased lymphocytes, decreased albumin, decreased sodium, increased gamma-glutamyltransferase, increased amylase, increased lipase, increased ALT, increased AST, and decreased hemoglobin.
Source: US FDA prescribing information
Certain P-gp substrates: Avoid coadministration of TEPMETKO with P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities.
Source: US FDA prescribing information
Store TEPMETKO at 20°C-25°C (68°F-77°F), excursions permitted to 15°C-30°C (59°F-86°F). Store in original package.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Tepotinib, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Tepmetko 225 mg tabletOral | EMD Serono | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Tepotinib in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Tepotinib and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Tepotinib, including Tepmetko.
Yes. The US FDA first approved Tepotinib on 3 February 2021, according to Drugs@FDA.
Yes. Tepotinib has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Tepotinib is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tepotinib is classified under ATC code L01EX21 (Tepotinib).
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