This site is intended for US healthcare professionals only.
Request a Rep
This site is intended for U.S. healthcare professionals only.
Request a Rep
Once-daily dosing1
Starting dosage: 450 mg (two 225-mg tablets)
Advise patients to:
- Take their dose at approximately the same time every day with food until disease progression or unacceptable toxicity
- Swallow tablets whole. Do not chew, crush, or split tablets
- Never make up a missed dose within 8 hours of the next scheduled dose. If vomiting occurs after taking a dose, take the next dose at the scheduled time
Convenient dose reduction1
remove one tablet to reduce dose to 225 mg once daily
- Permanently discontinue in patients who are unable to tolerate the 225-mg once-daily dose
- Management of some ARs may require temporary interruption or permanent discontinuation. See the full Prescribing Information for recommended dose modifications of TEPMETKO
- Place TEPMETKO tablet(s) in a glass containing 30 mL (1 ounce) of non-carbonated water. No other liquids should be used or added
- Stir, without crushing, until the tablet(s) is dispersed into small pieces (tablets will not completely dissolve) and drink immediately or within 1 hour
- Swallow the tablet dispersion. Do not chew pieces of the tablet
- Rinse the glass with an additional 30 mL and drink immediately ensuring no residue remains in the glass and the full dose is administered
If an administration via a nasogastric tube (with at least 8 French gauge) is required, disperse the tablet(s) in 30 mL of non-carbonated water as described above.
- Administer the 30 mL of liquid immediately or within 1 hour as per nasogastric tube manufacturer’s instructions
- Immediately rinse twice with 30 mL each time to ensure that no residue remains in the glass or syringe and the full dose is administered
Patients requiring treatment interruptions or dose reductions were able to continue to benefit from TEPMETKO2
Duration of treatment in treatment-naïve patients:
No dose reductions (n=95)
With dose reductions (n=69)
Patients with ≥1 treatment interruption are denoted by a yellow square on the left side of each panel. Patients with arrows were still on treatment.2
- Median DOT across treatment-naïve patients (n=164): 8.1 months (range: 0.03-59.37)3
- Median DOT in patients with at least one dose reduction (n=69): 11.0 months (range: 1.4-59.4)3
a450-mg active moiety.4
Tap to zoom in
Patients requiring treatment interruptions or dose reductions were able to continue to benefit from TEPMETKO2
Duration of treatment in previously treated patients:
No dose reductions (n=102)
With dose reductions (n=47)
Patients with ≥1 treatment interruption are denoted by a yellow square on the left side of each panel. Patients with arrows were still on treatment.2
- Median DOT across previously treated patients (n=149): 7.0 months (range: 0.03-71.85)3
- Median DOT in patients with at least one dose reduction (n=47): 11.0 months (range: 1.6-55.8)3
b450-mg active moiety.4
Tap to zoom in
- Treatment-naïve patients
- Previously treated patients
Patients requiring treatment interruptions or dose reductions were able to continue to benefit from TEPMETKO2
Duration of treatment in treatment-naïve patients:
No dose reductions (n=95)
With dose reductions (n=69)
Patients with ≥1 treatment interruption are denoted by a yellow square on the left side of each panel. Patients with arrows were still on treatment.2
- Median DOT across treatment-naïve patients (n=164): 8.1 months (range: 0.03-59.37)3
- Median DOT in patients with at least one dose reduction (n=69): 11.0 months (range: 1.4-59.4)3
a450-mg active moiety.4
Patients requiring treatment interruptions or dose reductions were able to continue to benefit from TEPMETKO2
Duration of treatment in previously treated patients:
No dose reductions (n=102)
With dose reductions (n=47)
Patients with ≥1 treatment interruption are denoted by a yellow square on the left side of each panel. Patients with arrows were still on treatment.2
- Median DOT across previously treated patients (n=149): 7.0 months (range: 0.03-71.85)3
- Median DOT in patients with at least one dose reduction (n=47): 11.0 months (range: 1.6-55.8)3
b450-mg active moiety.4
Starting dosage: 450 mg
(two 225-mg tablets)
225 mg tepotinib, white-pink, oval, biconvex film-coated tablet with embossment “M” on one side and plain on the other side.
| NDC number | Size |
| 44087-5000-3 | Box of 30 tablets: 3 blister cards each containing 10 tablets |
| 44087-5000-6 | Box of 60 tablets: 6 blister cards each containing 10 tablets |
The blister cards consist of a child-resistant blister foil.
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.
AR=adverse reaction; DOT=duration of treatment; FDA=US Food and Drug Administration; MET=mesenchymal-epithelial transition; METex14+=mesenchymal-epithelial transition gene exon 14 skipping alterations; mNSCLC=metastatic non-small cell lung cancer; NDC=National Drug Code.
IMPORTANT SAFETY INFORMATION
TEPMETKO can cause interstitial lung disease (ILD)/pneumonitis, which can be fatal. Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, fever). Immediately withhold TEPMETKO in patients with suspected ILD/pneumonitis and permanently discontinue if no other potential causes of ILD/pneumonitis are identified. ILD/pneumonitis occurred in 2% of patients treated with TEPMETKO, with one patient experiencing a Grade 3 or higher event; this event resulted in death.
TEPMETKO can cause hepatotoxicity, which can be fatal. Monitor liver function tests (including alanine aminotransferase [ALT], aspartate aminotransferase [AST], and total bilirubin) prior to the start of TEPMETKO, every 2 weeks during the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop increased transaminases or total bilirubin. Based on the severity of the adverse reaction, withhold, dose reduce, or permanently discontinue TEPMETKO. Increased ALT/increased AST occurred in 18% of patients treated with TEPMETKO. Grade 3 or 4 increased ALT/AST occurred in 4.7% of patients. A fatal adverse reaction of hepatic failure occurred in one patient (0.2%). The median time-to-onset of Grade 3 or higher increased ALT/AST was 47 days (range 1 to 262).
TEPMETKO can cause pancreatic toxicity in the form of elevations in amylase and lipase levels. Increased amylase and/or lipase occurred in 13% of patients, with Grade 3 and 4 increases occurring in 5% and 1.2% of patients, respectively. Monitor amylase and lipase levels at baseline and regularly during treatment with TEPMETKO and temporarily withhold, dose reduce, or permanently discontinue based on severity of the adverse event.
TEPMETKO can cause embryo-fetal toxicity. Based on findings in animal studies and its mechanism of action, TEPMETKO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential or males with female partners of reproductive potential to use effective contraception during treatment with TEPMETKO and for one week after the last dose.
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.
Fatal adverse reactions occurred in one patient (0.3%) due to pneumonitis, one patient (0.3%) due to hepatic failure, one patient (0.3%) due to dyspnea from fluid overload, one patient (0.3%) due to pneumonia, one patient (0.3%) due to sepsis, and one patient (0.3%) from unknown cause.
Serious adverse reactions occurred in 51% of patients who received TEPMETKO. Serious adverse reactions in >2% of patients included pleural effusion (6%), pneumonia (6%), edema (5%), general health deterioration (3.8%), dyspnea (3.5%), musculoskeletal pain (2.9%), and pulmonary embolism (2.2%).
The most common adverse reactions (≥20%) in patients who received TEPMETKO were edema (81%), nausea (31%), fatigue (30%), musculoskeletal pain (30%), diarrhea (29%), dyspnea (24%), rash (21%), and decreased appetite (21%).
Clinically relevant adverse reactions in <10% of patients who received TEPMETKO included ILD/pneumonitis, fever, dizziness, pruritus, and headache.
Selected laboratory abnormalities (≥20%) from baseline in patients receiving TEPMETKO in descending order were: decreased albumin (81%), increased creatinine (60%), decreased lymphocytes (57%), increased alkaline phosphatase (ALP) (52%), increased ALT (50%), increased AST (40%), decreased sodium (36%), decreased hemoglobin (31%), increased gamma-glutamyltransferase (GGT) (29%), increased potassium (26%), increased amylase (25%), decreased leukocytes (25%), decreased platelets (24%), and increased lipase (21%).
The most common Grade 3-4 laboratory abnormalities (≥2%) in descending order were: decreased lymphocytes (15%), decreased albumin (9%), decreased sodium (9%), increased GGT (6%), increased amylase (5%), increased lipase (5%), increased ALT (4.9%), increased AST (3.6%), and decreased hemoglobin (3.6%).
INDICATION
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.
Please see the full Prescribing Information for TEPMETKO.
Reference: 1. TEPMETKO. Prescribing information. EMD Serono, Inc.
References: 1. TEPMETKO. Prescribing information. EMD Serono, Inc. 2. Mazieres J, Paik PK, Garassino MC, et al. Tepotinib treatment in patients with MET exon 14–skipping non–small cell lung cancer: long-term follow-up of the VISION phase 2 nonrandomized clinical trial. JAMA Oncol. 2023;9(9):1260-1266. 3. Data on file. EMD Serono, Inc., Boston, MA. 4. Smit EF, Garassino MC, Felip E, et al. Tepotinib outcomes according to prior therapies in patients with MET exon 14 (METex14) skipping NSCLC. Poster presented at: European Society for Medical Oncology (ESMO) congress; September 9-13, 2022; Paris, France. Poster 985P. 5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.5.2026. © National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed May 8, 2026. To view the most recent and complete version of the guidelines, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
References: 1. TEPMETKO. Prescribing information. EMD Serono, Inc. 2. Paik PK, Felip E, Veillon R, et al. Tepotinib in non–small-cell lung cancer with MET exon 14 skipping mutations. N Engl J Med. 2020;383(10):931-943. 3. Mazieres J, Paik PK, Garassino MC, et al. Tepotinib treatment in patients with MET exon 14–skipping non–small cell lung cancer: long-term follow-up of the VISION phase 2 nonrandomized clinical trial. JAMA Oncol. 2023;9(9):1260-1266.
References: 1. TEPMETKO. Prescribing information. EMD Serono, Inc. 2. Paik PK, Felip E, Veillon R, et al. Tepotinib in non–small-cell lung cancer with MET exon 14 skipping mutations. N Engl J Med. 2020;383(10):931-943. 3. Data on file. EMD Serono, Inc., Boston, MA. 4. Mazieres J, Paik PK, Garassino MC, et al. Tepotinib treatment in patients with MET exon 14-skipping non-small cell lung cancer: long-term follow-up of the VISION phase 2 nonrandomized clinical trial. JAMA Oncol. 2023;9(9):1260-1266.
References: 1. Awad MM, Leonardi GC, Kravets S, et al. Impact of MET inhibitors on survival among patients with non-small cell lung cancer harboring MET exon 14 mutations: a retrospective analysis. Lung Cancer. 2019;133:96-102. 2. Salgia R. MET in lung cancer: biomarker selection based on scientific rationale. Mol Cancer Ther. 2017;16(4):555-565. 3. Asad Zadeh Vosta Kolaei F, Cai B, Kanakamedala H, et al. Biomarker testing patterns and treatment outcomes in patients with advanced non-small cell lung cancer and MET exon 14 skipping mutations: a descriptive analysis from the US. Front Oncol. 2022;12:786124. 4. TEPMETKO. Prescribing information. EMD Serono, Inc. 5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.5.2026. © National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed May 8, 2026. To view the most recent and complete version of the guidelines, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 6. Paik PK, Iams WT, Husain H, O'Hara RM Jr, Adewusi E, Le X. Tepotinib in patients with MET exon 14 skipping non-small cell lung cancer. Cancer Treat Rev. 2025;139:102990.
References: 1. TEPMETKO. Prescribing information. EMD Serono, Inc. 2. Mazieres J, Paik PK, Garassino MC, et al. Tepotinib treatment in patients with MET exon 14-skipping non-small cell lung cancer: long-term follow-up of the VISION phase 2 nonrandomized clinical trial. JAMA Oncol. 2023;9(9):1260-1266. 3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.5.2026. © National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed May 8, 2026. To view the most recent and complete version of the guidelines, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 4. Salgia R. MET in lung cancer: biomarker selection based on scientific rationale. Mol Cancer Ther. 2017;16(4):555-565. 5. Awad MM, Leonardi GC, Kravets S, et al. Impact of MET inhibitors on survival among patients with non-small cell lung cancer harboring MET exon 14 mutations: a retrospective analysis. Lung Cancer. 2019;133:96-102. 6. Asad Zadeh Vosta Kolaei F, Cai B, Kanakamedala H, et al. Biomarker testing patterns and treatment outcomes in patients with advanced non-small cell lung cancer and MET exon 14 skipping mutations: a descriptive analysis from the US. Front Oncol. 2022;12:786124. 7. Sabari JK, Leonardi GC, Shu CA, et al. PD-L1 expression, tumor mutational burden, and response to immunotherapy in patients with MET exon 14 altered lung cancers. Ann Oncol. 2018;29(10):2085-2091. 8. Paik PK, Felip E, Veillon R, et al. Tepotinib in non–small-cell lung cancer with MET exon 14 skipping mutations. N Engl J Med. 2020;383(10):931-943.
IMPORTANT SAFETY INFORMATION
TEPMETKO can cause interstitial lung disease (ILD)/pneumonitis, which can be fatal. Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, fever). Immediately withhold TEPMETKO in patients with suspected ILD/pneumonitis and permanently discontinue if no other potential causes of ILD/pneumonitis are identified. ILD/pneumonitis occurred in 2% of patients treated with TEPMETKO, with one patient experiencing a Grade 3 or higher event; this event resulted in death.
TEPMETKO can cause hepatotoxicity, which can be fatal. Monitor liver function tests (including alanine aminotransferase [ALT], aspartate aminotransferase [AST], and total bilirubin) prior to the start of TEPMETKO, every 2 weeks during the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop increased transaminases or total bilirubin. Based on the severity of the adverse reaction, withhold, dose reduce, or permanently discontinue TEPMETKO. Increased ALT/increased AST occurred in 18% of patients treated with TEPMETKO. Grade 3 or 4 increased ALT/AST occurred in 4.7% of patients. A fatal adverse reaction of hepatic failure occurred in one patient (0.2%). The median time-to-onset of Grade 3 or higher increased ALT/AST was 47 days (range 1 to 262).
TEPMETKO can cause pancreatic toxicity in the form of elevations in amylase and lipase levels. Increased amylase and/or lipase occurred in 13% of patients, with Grade 3 and 4 increases occurring in 5% and 1.2% of patients, respectively. Monitor amylase and lipase levels at baseline and regularly during treatment with TEPMETKO and temporarily withhold, dose reduce, or permanently discontinue based on severity of the adverse event.
TEPMETKO can cause embryo-fetal toxicity. Based on findings in animal studies and its mechanism of action, TEPMETKO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential or males with female partners of reproductive potential to use effective contraception during treatment with TEPMETKO and for one week after the last dose.
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.
Fatal adverse reactions occurred in one patient (0.3%) due to pneumonitis, one patient (0.3%) due to hepatic failure, one patient (0.3%) due to dyspnea from fluid overload, one patient (0.3%) due to pneumonia, one patient (0.3%) due to sepsis, and one patient (0.3%) from unknown cause.
Serious adverse reactions occurred in 51% of patients who received TEPMETKO. Serious adverse reactions in >2% of patients included pleural effusion (6%), pneumonia (6%), edema (5%), general health deterioration (3.8%), dyspnea (3.5%), musculoskeletal pain (2.9%), and pulmonary embolism (2.2%).
The most common adverse reactions (≥20%) in patients who received TEPMETKO were edema (81%), nausea (31%), fatigue (30%), musculoskeletal pain (30%), diarrhea (29%), dyspnea (24%), rash (21%), and decreased appetite (21%).
Clinically relevant adverse reactions in <10% of patients who received TEPMETKO included ILD/pneumonitis, fever, dizziness, pruritus, and headache.
Selected laboratory abnormalities (≥20%) from baseline in patients receiving TEPMETKO in descending order were: decreased albumin (81%), increased creatinine (60%), decreased lymphocytes (57%), increased alkaline phosphatase (ALP) (52%), increased ALT (50%), increased AST (40%), decreased sodium (36%), decreased hemoglobin (31%), increased gamma-glutamyltransferase (GGT) (29%), increased potassium (26%), increased amylase (25%), decreased leukocytes (25%), decreased platelets (24%), and increased lipase (21%).
The most common Grade 3-4 laboratory abnormalities (≥2%) in descending order were: decreased lymphocytes (15%), decreased albumin (9%), decreased sodium (9%), increased GGT (6%), increased amylase (5%), increased lipase (5%), increased ALT (4.9%), increased AST (3.6%), and decreased hemoglobin (3.6%).
INDICATION
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.
Please see the full Prescribing Information for TEPMETKO.
US-TEP-01116
Last update 07/2026
© 2026 Merck KGaA, Darmstadt, Germany and/or its affiliates. All rights reserved. EMD Serono is the Healthcare business of Merck KGaA, Darmstadt, Germany, in the United States and Canada. TEPMETKO and CoverOne are registered trademarks of Merck KGaA, Darmstadt, Germany and/or its affiliates.
This website is intended for U.S. healthcare professionals only.
Use and access of this site are subject to the terms and conditions set out in our Legal Statement and Privacy Policy.
US-TEP-01116
Last update 07/2026
© 2026 Merck KGaA, Darmstadt, Germany and/or its affiliates. All rights reserved. EMD Serono is the Healthcare business of Merck KGaA, Darmstadt, Germany, in the United States and Canada. TEPMETKO and CoverOne are registered trademarks of Merck KGaA, Darmstadt, Germany and/or its affiliates.
This website is intended for U.S. healthcare professionals only.
Use and access of this site are subject to the terms and conditions set out in our Legal Statement and Privacy Policy.