Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Tepotinib contains the active substance tepotinib. It belongs to a group of medicines called protein kinase inhibitors which are used to treat cancer. Tepotinib is used in adults to treat a type of lung cancer, called non-small cell lung cancer, that has certain abnormal changes in the mesenchymal-epithelial transition factor gene (MET) and which has spread and/or cannot be removed by surgery. The changes in the MET gene can make an abnormal protein which can then cause uncontrolled cell growth and cancer. By blocking this abnormal protein Tepotinib may slow or stop the cancer from growing. It may also help to shrink the cancer. Your doctor will perform a test to check if your cancer has a change in the MET gene to make sure that Tepotinib is right for you.
Package leaflet: Information for the patient
Tepotinib 225 mg film-coated tablets
Warnings and precautions Talk to your doctor or pharmacist before taking Tepotinib if any of the following apply to you: if you have or have had any other lung problems. if you have or have had liver problems. if you are pregnant or plan to become pregnant. if you are breastfeeding. Tell your doctor or pharmacist immediately if you develop any new or worsening symptoms during treatment (see section 4). Tepotinib may cause sudden breathing difficulties that may be associated with fever and cough. Blood tests Your doctor will take blood tests before and regularly during treatment with Tepotinib. Based on the results, your doctor may decide to interrupt your treatment, reduce your tepotinib dose or stop treatment permanently. Children and adolescents Tepotinib is not to be used in children and adolescents under the age of 18 years. Other medicines and Tepotinib Tell your doctor if you are using, have recently used or might use any other medicines. Tepotinib may affect how well the following medicines work and/or increase side effects of these medicines: digoxin – used to treat irregular heart beat or other heart problems metformin – used to treat diabetes mellitus Pregnancy Do not take Tepotinib if you are pregnant or suspect you are pregnant, unless advised by your doctor. Tepotinib may harm the unborn baby. Contraception If you are female and are of childbearing age, you should use an effective method of contraception to avoid becoming pregnant during Tepotinib treatment and for at least 1 week after the last dose. Talk to your doctor if you take hormonal contraceptives (e.g. "the pill"). You need a second method of contraception during Tepotinib treatment and for at least 1 week after the last dose. If you are male, you should use barrier contraception to prevent your partner from getting pregnant, whilst you are treated with Tepotinib and for at least 1 week after the last dose. Breast-feeding It is not known whether Tepotinib may pass to the baby via breast milk. Do not breast-feed during treatment with Tepotinib and for at least 1 week after the last dose. Driving and using machines You should take special care when driving and using machines as you may feel unusually tired while taking Tepotinib. Tepotinib contains lactose Tepotinib contains 4.15 mg lactose in each tablet. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects Contact your doctor immediately for any of the following: if you develop any new or worsening symptoms such as sudden breathing difficulties, shortness of breath, cough or fever. These may be symptoms of a serious lung condition (interstitial lung disease) which needs immediate medical attention. This side effect is common (may affect up to 1 in 10 people). if you develop yellow discolouration of the skin and eyes (jaundice), darkening of the urine, light-coloured stools (faeces), loss of appetite, nausea or vomiting, pain on the upper right side of your stomach area. These are symptoms and signs of liver problems.
Other side effects Very common side effects (may affect more than 1 in 10 people) Swelling caused by fluid build-up in the body (oedema) Decreased appetite Feeling sick (nausea) Being sick (vomiting) Diarrhoea Abdominal pain Constipation Fatigue or tiredness Muscle and joint pain Skin rash Higher than normal blood levels of creatinine Higher than normal blood levels of lipase Higher than normal blood levels of amylase Reduced protein levels in the blood Higher than normal blood levels of certain liver enzymes (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase) Common side effects (may affect up to 1 in 10 people) Higher than normal blood levels of a certain liver enzyme (gamma-glutamyltransferase) Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
What Tepotinib looks like and contents of the pack Tepotinib film-coated tablets are white-pink, oval and biconvex with embossment 'M' on one side and plain on the other side. Each pack contains 60 tablets in aluminium/polyvinyl chloride-polyethylenepolyvinylidene chloride-polyethylene-polyvinyl chloride blisters. Marketing Authorisation Holder Merck Serono Ltd 5 New Square Bedfont Lakes Business Park Feltham Middlesex TW14 8HA UK Manufacturer Merck Healthcare KGaA Frankfurter Strasse 250 64293 Darmstadt Germany This leaflet was last revised in 09/2026 This medicine has been given 'conditional approval'. This means that there is more evidence to come about this medicine. The MHRA will review new information on this medicine at least every year and this leaflet will be updated as necessary.
Tepotinib 225 mg film-coated tablets 225 mg comes as tablet containing 225 mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Tepotinib 225 mg film-coated tablets 225 mg is tepotinib hydrochloride hydrate.
Medicines with the same active substance include: TEPMETKO 225 mg film-coated tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Tepotinib 225 mg film-coated tablets 225 mg, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Tepotinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations.
Treatment must be initiated and supervised by a physician experienced in the use of anticancer therapies.
Assessment of METex14 skipping alterations status
Prior to initiation of treatment with Tepotinib the presence of METex14 skipping alterations should be confirmed by a validated test method using nucleic acids isolated from either tumour or plasma specimens. Testing for the presence of METex14 skipping alterations in tissue specimens is recommended because of higher sensitivity. However, plasma specimens may be used in patients for whom a tumour biopsy cannot be obtained. If an alteration is not detected in a plasma specimen, the feasibility of biopsy for tumour tissue testing should be evaluated.
Posology
The recommended dose is 450 mg tepotinib (2 tablets) taken once daily. Treatment should continue until disease progression or unacceptable toxicity.
If a daily dose is missed, it can be taken as soon as remembered on the same day, unless the next dose is due within 8 hours.
Dose modification for adverse reactions
Dose interruption, dose reduction or discontinuation of treatment with Tepotinib may be required based on adverse reactions. The recommended dose reduction level for the management of adverse reactions is 225 mg (1 tablet) daily. Tepotinib should be permanently discontinued if patients are unable to tolerate 225 mg (1 tablet) daily. Detailed recommendations for dose modification are provided in the table below.
| Recommended dose modifications for Tepotinib for adverse reactions | ||
| Adverse reaction | Severity | Dose modification |
| Interstitial Lung Disease (ILD) (see section 4.4) | Any grade | Withhold tepotinib if ILD is suspected. Permanently discontinue tepotinib if ILD is confirmed. |
| Increased ALT and/or AST without increased total bilirubin (see section 4.4) | Grade 3 | Withhold tepotinib until recovery to baseline ALT/AST. If recovered to baseline within 7 days, then resume tepotinib at the same dose; otherwise resume tepotinib at a reduced dose. |
| Grade 4 | Permanently discontinue tepotinib. | |
| Increased ALT and/or AST with increased total bilirubin in the absence of cholestasis or hemolysis (see section 4.4) | ALT and/or AST greater than 3 times ULN with total bilirubin greater than 2 times ULN | Permanently discontinue tepotinib. |
| Increased total bilirubin without concurrent increased ALT and/or AST (see section 4.4) | Grade 3 | Withhold tepotinib until recovery to baseline bilirubin. If recovered to baseline within 7 days, then resume tepotinib at a reduced dose; otherwise permanently discontinue. |
| Grade 4 | Permanently discontinue tepotinib. | |
| Other adverse reactions (see section 4.8) | Grade 2 | Maintain dose level. If intolerable, consider withholding tepotinib until resolved, then resume tepotinib at a reduced dose. |
| Grade 3 | Withhold tepotinib until resolved, then resume tepotinib at a reduced dose. | |
| Grade 4 | Permanently discontinue tepotinib. | |
Renal impairment
No dose adjustment is recommended in patients with mild or moderate renal impairment (creatinine clearance 30 to 89 mL/min) (see section 5.2). The pharmacokinetics and safety of tepotinib in patients with severe renal impairment (creatinine clearance below 30 mL/min) have not been studied.
Hepatic impairment
No dose adjustment is recommended in patients with mild (Child Pugh Class A) or moderate (Child Pugh Class B) hepatic impairment (see section 5.2). The pharmacokinetics and safety of tepotinib in patients with severe hepatic impairment (Child Pugh Class C) have not been studied.
Elderly
No dose adjustment is necessary in patients aged 65 years and above (see section 5.2).
Paediatric population
Safety and efficacy of Tepotinib in paediatric patients below 18 years of age have not been established.
Method of administration
Tepotinib is for oral use. The tablet(s) should be taken with food and should be swallowed whole (patients should not crush or chew the tablet before swallowing).
If the patient is unable to swallow, the tablets can be dispersed in 30 mL of non-carbonated water. No other liquids should be used or added. The tablets should be dropped in a glass with water without crushing and stirred until the tablets are dispersed into small pieces (the tablet will not completely dissolve). The dispersion should be thoroughly stirred and should be swallowed immediately or within 1 hour. The pieces of the tablet should not be chewed. If the dispersion is taken within 1 hour, it should be thoroughly stirred again to ensure the whole dose is administered. In both cases, the glass should be rinsed with an additional 30 mL to ensure that no residue remains and should be swallowed immediately.
If an administration via a naso-gastric tube (with at least 8 French gauge) is required, the tablets should be dispersed in 30 mL of non-carbonated water as described above. The 30 mL of liquid should be thoroughly stirred, then drawn up by syringe and administered immediately or within 1 hour as per naso-gastric tube manufacturer's instructions. If the drawn-up suspension in the syringe is administered within 1 hour, it should first be shaken thoroughly to disperse the contents again. In both cases, immediately rinse twice with 30 mL each to ensure that no residue remains in the syringe.
Hypersensitivity to tepotinib or to any of the excipients listed in section 6.1.
Pharmacokinetic interactions
P-gp substrates
Tepotinib can inhibit the transport of sensitive substrates of P‑gp (see section 5.2). Monitoring of the clinical effects of P‑gp-dependent substances with a narrow therapeutic index (e.g. digoxin) is recommended during co-administration with Tepotinib.
BCRP substrates
Tepotinib can inhibit the transport of sensitive substrates of the Breast Cancer Resistance Protein (BCRP) (see section 5.2). Monitoring of the clinical effects of sensitive BCRP substrates is recommended during co-administration with Tepotinib.
Metformin
Based on in vitro data, tepotinib or its metabolite may have the potential to alter the exposure to co-administered metformin in humans through inhibition of metformin's renal excretion or hepatic uptake mediated via OCT1 and 2 and MATE1 and 2 (see section 5.2). Monitoring of the clinical effects of metformin is recommended during co-administration with Tepotinib.
Contraception in males and females
Pregnancy testing is recommended in women of childbearing potential prior to initiating treatment with Tepotinib.
Women of childbearing potential should use effective contraception during Tepotinib treatment and for at least 1 week after the last dose.
Male patients with female partners of childbearing potential should use barrier contraception during Tepotinib treatment and for at least 1 week after the last dose.
Pregnancy
There are no clinical data on the use of Tepotinib in pregnant women. Studies in animals have shown teratogenicity (see section 5.3). Based on the mechanism of action and findings in animals Tepotinib can cause foetal harm when administered to pregnant women.
Tepotinib should not be used during pregnancy, unless the clinical condition of the woman requires treatment with tepotinib. Women of childbearing potential or male patients with female partners of childbearing potential should be advised of the potential risk to a foetus.
Breast-feeding
There are no data regarding the secretion of tepotinib or its metabolites in human milk or its effects on the breast-fed infant or milk production. Breast-feeding should be discontinued during treatment with Tepotinib and for at least 1 week after the last dose.
Fertility
No human data on the effect of Tepotinib on fertility are available. No morphological changes in male or female reproductive organs were seen in the repeat-dose toxicity studies in rats and dogs (see section 5.3).
Tepotinib may have minor influence on the ability to drive and use machines. During treatment with tepotinib, fatigue and asthenia have been reported.
Tepotinib has been investigated at doses up to 1,261 mg. Symptoms of overdose have not been identified. There is no specific treatment in the event of tepotinib overdose. In case of overdose, Tepotinib should be withheld and symptomatic treatment initiated.
Ask anything about Tepotinib 225 mg film-coated tablets 225 mg. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
We use essential cookies to make the site work. We would also like to set optional cookies to understand how the site is used, so we can improve it. We will not set optional cookies unless you accept. See our cookie policy and privacy policy.