TM Owner Merck KGaA / EMD Serono
Tepmetko 225mg Tablet
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Indications & Clinical Uses
- Tepmetko (tepotinib) 225 mg tablets are a targeted oral therapy for adults with metastatic non-small cell lung cancer (NSCLC) whose tumour carries mesenchymal-epithelial transition (MET) exon 14 skipping alterations, identified through a specific tumour or blood test.
- Tepotinib is a MET kinase inhibitor, blocking a growth signal some lung cancers depend on.
- Tepmetko was developed by Merck KGaA of Darmstadt, Germany, and is marketed in the United States by its biopharmaceutical business EMD Serono, and elsewhere as Tepmetko by Merck; the molecule and dose are the same worldwide, though the corporate name differs by market because the unrelated US company Merck & Co uses the Merck name in North America.
- In the US, Tepmetko received full approval in 2024 after initial accelerated approval in 2021.
- It is taken once daily by mouth with food, usually continued for as long as it provides benefit and is tolerated.
Side Effects
- The most common Tepmetko side effects, each affecting 1 in 5 or more patients, are swelling (oedema, often in the legs or around the eyes), nausea, fatigue, muscle or joint pain, diarrhoea, shortness of breath, reduced appetite and rash.
- Tepmetko has no boxed warning on the current US label, but it carries important warnings: interstitial lung disease or pneumonitis, which can be fatal, has occurred and treatment must be stopped straight away if suspected; liver enzyme elevations can occur and liver function is checked regularly; pancreatic enzyme increases (amylase and lipase) can occur; and Tepmetko causes fetal harm, so effective contraception is required during treatment and for a week after the last dose.
- Seek urgent medical attention for new or worsening cough, breathlessness or fever, or for yellowing of the skin or eyes.
Precautions & Warnings
- Before starting Tepmetko, liver function tests should be checked and repeated regularly during treatment, since hepatotoxicity has been reported; the dose may need to be reduced, interrupted, or permanently stopped depending on severity.
- Interstitial lung disease and pneumonitis can occur at any time during treatment and can be fatal, so new or worsening breathing symptoms should be reported and treatment withheld immediately while investigated.
- Pancreatic enzyme levels should also be monitored, since amylase and lipase increases have been observed.
- Tepmetko causes fetal harm and must not be used in pregnancy; effective contraception is required for women of childbearing potential during treatment and for one week after the final dose, and men with partners who could become pregnant should also use contraception.
- Tepmetko has not been studied in children.
- It is taken as a tablet by mouth; there is no injectable or infusion form.
Avoid Interactions
- Strong or moderate CYP3A4 inhibitors, such as certain antifungal and antibiotic medicines, can increase tepotinib levels and side-effect risk, and strong or moderate CYP3A4 inducers, such as rifampin or St John's Wort, can reduce its effect - both combinations should be avoided or used with caution under specialist guidance.
- Tepotinib increases levels of P-glycoprotein (P-gp) substrate drugs, including some anticoagulants such as dabigatran, where even small increases can raise serious bleeding risk, so these combinations need caution and monitoring.
- Tepmetko may also increase levels of other narrow-therapeutic-index P-gp or BCRP substrate drugs.
- Tell your healthcare provider and pharmacist about every other prescription medicine, over-the-counter product, herbal supplement (including St John's Wort) and grapefruit product you use before starting Tepmetko.
References
Frequently Asked Questions
Tepmetko (tepotinib) treats adults with metastatic non-small cell lung cancer whose tumour has a MET exon 14 skipping alteration, found through a specific genetic test. It blocks a growth signal (MET) the cancer cells rely on. Your doctor tests your tumour before prescribing it.
Take Tepmetko 225 mg tablets by mouth once a day, with food, at about the same time each day. Swallow tablets whole; do not chew or crush them. Continue taking Tepmetko for as long as your doctor says it is helping and you tolerate it.
Common Tepmetko side effects include swelling, nausea, fatigue, muscle pain and diarrhoea. It can also cause lung inflammation (pneumonitis), which can be fatal, and liver problems. Get urgent help for new or worsening cough, breathlessness, fever, or yellowing of the skin or eyes.
Avoid strong CYP3A4 inhibitors like certain antifungals, and inducers like rifampin or St John's Wort, as these change Tepmetko levels. Be cautious with blood thinners such as dabigatran. Avoid pregnancy during treatment and for a week after your last dose.
You will have regular liver function tests, and your doctor watches for signs of lung inflammation such as new cough or breathlessness, plus pancreatic enzyme changes. Tell your care team immediately about any new breathing symptoms, since pneumonitis on Tepmetko can be serious or fatal.
No. Tepmetko can cause fetal harm, so it should not be used during pregnancy. Effective contraception is needed during treatment and for one week after the last dose, for women and for men with partners who could become pregnant. Tell your doctor right away if you become pregnant.
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