Tepmetko – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Tepmetko, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
ℹ️ 1. What TEPMETKO is and what it is used for
TEPMETKO contains the active substance tepotinib. It belongs to a group of medicines called ‘protein kinase inhibitors’ which are used to treat cancer.
TEPMETKO is used to treat adults with lung cancer that has spread to other parts of the body or cannot be removed by surgery. The medicine is given, when the cancer cells have an alteration in the MET (mesenchymal -epithelial transition factor) gene and previous treatment has not helped to stop your disease .
An alteration in the MET gene can lead to production of an abnormal protein, which can then cause uncontrolled cell growth and cancer. By blocking the action of the abnormal protein, TEPMETKO may slow or stop the cancer from growing. It may also help to shrink the cancer.
⚠️ 2. What you need to know before you take TEPMETKO
Do not take TEPMETKO
- if you are allergic to tepotinib or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before taking this medicine if you have any questions.
Lung or breathing problems TEPMETKO can sometimes cause sudden breathing difficulties that may be associated with a fever and cough. Tell your doctor right away if you develop any new or worsening symptoms (see section 4) as these may be signs of a serious lung condition (interstitial lung disease) which needs immediate attention. Your doctor may need to treat you with other medicines and interrupt your TEPMETKO treatment.
25 Monitoring of liver function Your doctor will carry out blood tests to check how well your liver is working before you are treated with TEPMETKO, and as necessary during treatment.
Monitoring of heart function Your doctor may carry out ECG tests as necessary during treatment to check whether TEPMETKO affects your heart rhythm.
Contraception This medicine should not be used in pregnancy as it can harm the unborn baby. Men and women should use effective contraception during TEPMETKO treatment and for at least 1 week after the last dose. Your doctor will give you guidance on appropriate methods of contraception. See ‘Pregnancy’ below.
Children and adolescents
Do not give t his medicine to children and adolescents as it has not been studied in people below 18 years of age.
Other medicines and TEPMETKO
Tell your doctor if you are using, have recently used or might use any other medicines.
TEPMETKO may affect how well the following medicines work and/or increase side effects of these medicines:
- dabigatran – used to prevent stroke or venous thrombosis/pulmonary embolism
- digoxin – used to treat irregular heartbeat or other heart problems
- aliskiren – used to treat high blood pressure
- everolimus – used to treat cancer
- sirolimus – used to prevent organ rejection in transplanted patients
- rosuvastatin – used to treat high blood fat levels
- methotrexate – used to treat inflammatory diseases or cancer
- topotecan – used to treat cancer
- metformin – used to treat diabetes
Pregnancy
Do not take TEPMETKO if you are pregnant or suspect you are pregnant, unless advised by your doctor. This medicine may harm the unborn baby. Pregnancy testing is recommended prior to starting treatment with TEPMETKO.
Contraception in males and females If you are female and able to have children, you should use an effective method of contraception to avoid becoming pregnant during TEPMETKO treatment and for at least 1 week after the last dose.
Talk to your doctor if you take hormonal contraceptives (e.g. ‘the pill’) as you will need a second method of contraception during this time.
If you are male, you should use a barrier method of contraception to prevent your partner from getting pregnant, while you are treated with TEPMETKO and for at least 1 week after the last dose.
Your doctor will give you guidance on appropriate methods of contraception.
Breast -feeding It is not known whether TEPMETKO may pass to the baby via breast milk. Stop breast -feeding your baby while you are treated with this medicine and for at least 1 week after the last dose.
Driving and using machines
TEPMETKO has no influence on the ability to drive or use machines.
💊 3. How to take TEPMETKO
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
The recommended dose is 2 tablets of TEPMETKO taken by mouth once daily. You may continue to take this medicine daily as long as you are benefitting from it and are not having intolerable side effects. In case of intolerable side effects, your doctor may advise you to reduce the do se to 1 tablet daily or interrupt the treatment for some days.
Take the tablets with food or shortly after a meal, swallow them whole and do not chew. This will ensure that the whole dose enters your system.
If you have trouble swallowing the tablets, you can mix it in water:
- Put the tablets in a glass without crushing.
- Add 30 mL (equivalent to two tablespoons) of still (non- fizzy) water – do not use any other liquids.
- Stir the water until the tablet breaks up into very small pieces which may take a few minutes – the tablet will not completely dissolve.
- Drink the liquid within one hour.
- To make sure you have taken all of the medicine, rinse the glass thoroughly with another 30 mL of water and drink it immediately .
If you have a naso- gastric (NG) tube that is 8 French gauge or larger:
- Follow the same instruction for mixing the tablets in 30 mL of non- carbonated water as described above.
- Administer the liquid within 1 hour using the NG tube manufacturer’s instructions.
- To make sure you have taken all of the medicine, rinse the glass and syringe twice with another 30 mL of water to ensure that no medicine remains in the glass or syringe and the full dose is administered .
If you take more TEPMETKO than you should
Experience with overdose of TEPMETKO is limited. Symptoms of overdose will most likely be similar to those mentioned under possible side effects (see section 4). If you have taken more TEPMETKO than you should, talk to your doctor.
If you forget to take TEPMETKO
If you miss a dose of TEPMETKO, take it as soon as you remember. However, if your next dose is due within 8 hours, skip the missed dose and take your next dose at your regular time. Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
❗ 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Lung or breathing problems Tell your doctor right away if you develop any new or worsening symptoms such as sudden breathing difficulties, cough or fever. These may be signs 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).
27 Other side effects Talk to your doctor if you get any other side effects. These can include:
Very common side effects (may affect more than 1 in 10 people)
- Swelling caused by fluid build- up in the body (oedema)
- Feeling sick (nausea) or being sick (vomiting)
- Diarrhoea Very common abnormal laboratory values that show up in blood tests (may affect more than 1 in 10 people)
- Raised levels of creatinine in blood (a sign of possible kidney problems)
- Raised levels of alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase in blood (a sign of possible liver problems)
- Raised levels of amylase or lipase in blood (a sign of possible digestive problems)
- Reduced levels of the protein albumin in blood
Common side effects (may affect up to 1 in 10 people)
- Change in electrical activity of the heart seen on ECG (QT prolongation)
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 the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
🌡️ 5. How to store TEPMETKO
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
📦 6. Contents of the pack and other information
What TEPMETKO contains
- The active substance is tepotinib. Each film -coated tablet contains 225 mg tepotinib (as hydrochloride hydrate).
- The other ingredients are mannitol, colloidal anhydrous silica, crospovidone, magnesium stearate and microcrystalline cellulose in the tablet core and polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (polyethylene glycol), talc (E553b), and red iron oxide (E172) in the film -coating.
What TEPMETKO looks like and contents of the pack
TEPMETKO film -coated tablets are white- pink, oval, biconvex, approximately 18×9 mm in size and embossed with ‘M’ on one side and plain on the other side. Each pack contains 60 tablets in a transparent blister, which consists of a multilayer composite form foil and an aluminium lidding .
28 Marketing Authorisation Holder Merck Europe B.V.
Gustav Mahlerplein 102 1082 MA Amsterdam The Netherlands
Manufacturer
Merck Healthcare KGaA Frankfurter Strasse 250 64293 Darmstadt Germany
This leaflet was last revised in
Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu .
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Tepmetko (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/21/1596).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.