Tepotinib: uses, dosing, side effects & brands
Tepotinib is a kinase inhibitor sold in the U.S. under one brand. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Kinase Inhibitor
- Available as
- Tablet
- Sold as
- Tepmetko
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How tepotinib is dosed
From the FDA label for Tepmetko (application NDA214096). Other tepotinib products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Select patients for treatment with TEPMETKO on the presence of MET ex14 skipping. ( 2.1 , 14 ) Recommended dosage : 450 mg orally once daily with food until disease progression or unacceptable toxicity. ( 2.2 ) 2.1 Patient Selection for METex14 Skipping Alterations Select patients for treatment with TEPMETKO based on the presence of MET exon 14 skipping alterations in plasma or tumor specimens. Testing for the presence of MET exon 14 skipping alterations in plasma specimens is recommended only in patients for whom a tumor biopsy cannot be obtained. If an alteration is not detected in a plasma specimen, re-evaluate the feasibility of biopsy for tumor tissue testing. An FDA-approved test for detection of MET exon 14 skipping alterations in NSCLC for selecting patients for treatment with TEPMETKO is not available. 2.2 Recommended Dosage The recommended dosage of TEPMETKO is 450 mg orally once daily with food [see Clinical Pharmacology (12.3) ] until disease progression or unacceptable toxicity. Instruct patients to take their dose of TEPMETKO at approximately the same time every day and to swallow tablets whole. Do not chew, crush or split tablets. Patients who have difficulty swallowing solids can disperse tablets in water [see Dosage and Administration (2.3) ]. Advise patients not to make up a missed dose within 8 hours of the next scheduled dose. If vomiting occurs after…
Tepotinib side effects
The following adverse reactions are described in greater detail elsewhere in the labeling: Interstitial Lung Disease/Pneumonitis [see Warnings and Precautions (5.1) ] Hepatotoxicity [see Warnings and Precautions (5.2) ] Pancreatic Toxicity [see Warnings and Precautions (5.3) ] 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact EMD Serono at 1-800-283-8088 ext. 5563 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety population described in the WARNINGS AND PRECAUTIONS reflect exposure to TEPMETKO in 506 patients with solid tumors enrolled in five open-label, single-arm studies receiving TEPMETKO as single agent at a dose of 450 mg once daily. This included 313 patients with NSCLC…
Who shouldn’t take tepotinib
None. None. ( 4 )
Tepotinib drug interactions
Certain P-gp substrates : Avoid coadministration of TEPMETKO with P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities. ( 7.1 ) 7.1 Effects of TEPMETKO on Other Drugs Certain P-gp Substrates Tepotinib is a P-gp inhibitor. Concomitant use of TEPMETKO increases the concentration of P-gp substrates [see Clinical Pharmacology (12.3) ], which may increase the incidence and severity of adverse reactions of these substrates. Avoid concomitant use of TEPMETKO with certain P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities. If concomitant use is unavoidable, reduce the P-gp substrate dosage if recommended in its approved product labeling.
Every tepotinib product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Tepmetko.
What tepotinib pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| M | 225 mg | pink | oval | — |
Can you crush or split tepotinib?
At least one tepotinibproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each tepotinib label says about crushing, splitting and chewingWhat people report to the FDA about tepotinib
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1 reports naming tepotinib, and the FDA flagged 100% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- creutzfeldt-jakob disease1 reports
- malignant neoplasm progression1 reports
Read these as a signal, not a rate. A report does not mean tepotinib caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 26, 2026.
Related calculators
Frequently asked questions
What is tepotinib?
Tepotinib is a kinase inhibitor. TEPMETKO (tepotinib) tablets for oral use are formulated with tepotinib hydrochloride hydrate.
What kind of drug is tepotinib?
The FDA classifies tepotinib as a kinase inhibitor. Kinase inhibitors block protein kinases, the enzymes that relay 'grow and divide' signals inside cells. By shutting down the overactive kinase signals that a tumor depends on, they help slow or stop cancer cells from multiplying. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take tepotinib with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run tepotinib against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does tepotinib come in?
Across the brands we track, tepotinib is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic tepotinib?
We do not currently list a generic-labelled tepotinib product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Tepotinib: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/tepotinib
- MLA
- “Tepotinib: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/tepotinib.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for tepotinib on DailyMed (NIH) ↗.