Tepmetko
Italy
Table of Contents
Patient Information Leaflet
TEPMETKO 225 mg film-coated tablets
tepotinib
This medicinal product is subject to additional monitoring. This will allow any new safety information to be identified quickly. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
- If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet
- What TEPMETKO is and what it is used for
- What you need to know before taking TEPMETKO
- How to take TEPMETKO
- Possible side effects
- How to store TEPMETKO
- Contents of the pack and other information
1. What TEPMETKO is and what it is used for
TEPMETKO contains the active substance tepotinib and belongs to a group of medicines called
"protein kinase inhibitors" which are used to treat cancer.
TEPMETKO is used to treat adult patients with lung cancer that has spread to other parts of the body or cannot be removed by surgery. This medicine is given when cancer cells have a genetic alteration in the MET gene (mesenchymal-epithelial transition factor) and previous treatment has not helped to stop the disease.
An alteration in the MET gene may lead to the production of an abnormal protein, which in turn can cause uncontrolled cell growth and cancer. By blocking the action of this abnormal protein, TEPMETKO may slow down or stop cancer growth and may also help reduce its size.
2. What you should know before taking TEPMETKO
Do not take TEPMETKO
- if you are allergic to tepotinib or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
If you have any doubts, please consult your doctor before taking this medicine.
Lung or breathing problems
TEPMETKO may sometimes cause sudden breathing difficulties, which may be associated with fever and cough. Immediately inform your doctor if you develop new or worsening symptoms (see section 4), as these could be signs of a serious lung disease (interstitial lung disease) requiring immediate medical intervention. Your doctor may need to treat you with other medicines and discontinue treatment with TEPMETKO.
Liver function monitoring
Your doctor will perform blood tests to monitor liver function before starting treatment with TEPMETKO and, as needed, during treatment.
Heart function monitoring
If necessary, your doctor may perform an ECG during treatment to check whether TEPMETKO affects your heart rhythm.
Contraception
This medicine must not be used during pregnancy as it may cause harm to the unborn child.
Patients of both sexes must use effective contraception during treatment with TEPMETKO and for at least 1 week after the last dose. Your doctor will advise you on the most appropriate contraceptive methods. See section below “Pregnancy”.
Children and adolescents
This medicine has not been studied in patients under 18 years of age.
Other medicines and TEPMETKO
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
TEPMETKO may affect the way the following medicines work and/or increase their side effects:
- dabigatran – used to prevent stroke or venous thrombosis/pulmonary embolism
- digoxin – used to treat irregular heartbeat or other heart problems
- aliskiren – used to treat hypertension
- everolimus – used to treat cancer
- sirolimus – used to prevent organ rejection in transplant 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 and breastfeeding
Pregnancy
Do not take TEPMETKO if you are pregnant or suspect you may be pregnant, unless advised by your doctor. This medicine may cause harm to the unborn child. A pregnancy test is recommended before starting treatment with TEPMETKO.
Contraception in men and women
If you are a woman of childbearing potential, you must use effective contraceptive methods to prevent pregnancy during treatment with TEPMETKO and for at least 1 week after the last dose. Inform your doctor if you are taking hormonal contraceptives (e.g. the “pill”), as you will need to use a second contraceptive method during this period.
If you are a man, you must use a barrier contraceptive method to prevent pregnancy in your partner during treatment with TEPMETKO and for at least 1 week after the last dose.
Your doctor will advise you on suitable contraceptive methods.
Breastfeeding
It is not known whether TEPMETKO passes into breast milk. You must stop breastfeeding during treatment with this medicine and for at least 1 week after the last dose.
Driving and using machines
TEPMETKO does not affect the ability to drive or operate machinery.
TEPMETKO contains lactose
TEPMETKO contains 4.4 mg of monohydrated lactose per tablet. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
3. How to take TEPMETKO
Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor.
The recommended dose is 2 TEPMETKO tablets, taken orally once daily.
You may continue taking this medicine every day for as long as you benefit from it and do not experience intolerable side effects. If intolerable side effects occur, your doctor may advise you to reduce the dose to 1 tablet per day or to interrupt treatment for a few days.
Take the tablets with food or shortly after a meal. Swallow the tablets whole, without chewing them. This will ensure that the full dose enters your body.
If you have difficulty swallowing the tablets, you may mix them with water:
- Place the tablets in a glass without crushing them.
- Add 30 mL (equivalent to two tablespoons) of plain water (non-carbonated) – do not use any other liquid.
- Stir until the tablets disintegrate into very small pieces. This may take several minutes – the tablet will not dissolve completely.
- Drink the liquid within one hour.
- To ensure that you have taken the complete dose, rinse the glass thoroughly with an additional 30 mL of water and immediately drink the rinse water.
If you have a nasogastric (NG) tube with a size of 8 French or larger:
- Disperse the tablets in 30 mL of non-carbonated water as described above.
- Administer the liquid within one hour, following the manufacturer's instructions for the NG tube.
- To ensure that you have taken the complete dose, rinse the glass and syringe twice with 30 mL of water each time to make sure no residue of the medicine remains in the glass or syringe, ensuring the full dose is administered.
If you take more TEPMETKO than you should
Experience with overdose of TEPMETKO is limited. Symptoms of overdose are likely to be similar to those listed under "Possible side effects" (see section 4). If you have taken more TEPMETKO than you should, contact your doctor.
If you forget to take TEPMETKO
If you forget to take a dose of TEPMETKO, take it as soon as you remember. If the next dose is due within 8 hours, skip the missed dose and take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will get them.
Serious side effects
Lung or breathing problems
Contact your doctor immediately if you develop new or worsening symptoms such as sudden breathing
difficulties, cough, or fever. These symptoms may be signs of a serious lung disease (interstitial lung
disease) that requires immediate medical attention and is a common side effect (may affect up to 1 in
10 people).
Other side effects
Contact your doctor if you experience any other side effects, including:
Very common side effects (may affect more than 1 in 10 people)
- Swelling due to fluid retention in the body (oedema)
- Nausea or vomiting
- Diarrhoea
- Increased levels of creatinine in the blood (a sign of possible kidney problems)
- Increased levels of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase in the blood (a sign of possible liver problems)
- Increased levels of amylase or lipase in the blood (a sign of possible digestive problems)
- Reduced levels of albumin (a protein) in the blood
Common side effects (may affect up to 1 in 10 people)
- Changes in the heart's electrical activity seen on an ECG (QT prolongation)
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system detailed in Annex 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 after "Exp" and on 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 dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What TEPMETKO contains
- The active substance is tepotinib. Each film-coated tablet contains 225 mg of tepotinib (as hydrochloride hydrate).
- The other components are mannitol, anhydrous colloidal silica, crospovidone, magnesium stearate and microcrystalline cellulose in the tablet core, and hypromellose, monohydrate lactose (see section 2, “TEPMETKO contains lactose”), macrogol, triacetin, red iron oxide (E172) and titanium dioxide (E171) in the coating film.
Description of the appearance of TEPMETKO and package contents
TEPMETKO film-coated tablets are white-pink in colour, oval-shaped, biconvex, approximately 18x9 mm in size, with the letter “M” engraved on one side and smooth on the other. Each pack contains 60 tablets in transparent blisters, composed of a multilayer composite formed sheet with aluminium covering.
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
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu