TEPMETKO 225 mg Film-Coated Tablets

Зміст інструкції

1. TEPMETKO 225 mg film-coated tablets
   1. What is TEPMETKO and what is it used for
   2. What you need to know before you take TEPMETKO
   3. How to take TEPMETKO
   4. Possible side effects
   5. How to store TEPMETKO
   6. Contents of the pack and other information

TEPMETKO 225 mg film-coated tablets

tepotinib

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What TEPMETKO is and what it is used for
• 2. What you need to know before you take TEPMETKO
• 3. How to take TEPMETKO
• 4. Possible side effects
• 5. How to store TEPMETKO
• 6. Contents of the pack and other information

1. What is TEPMETKO and what is it 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 that cannot be removed with surgery. This medicine is administered
when the cancer cells present an alteration of the METgene (mesenchymal-epithelial transition
factor) and previous treatment has not helped to stop the disease.
An alteration of the METgene can lead to the production of an abnormal protein, which,
consequently, can cause uncontrolled cell growth and cancer. By blocking the action of the
abnormal protein, TEPMETKO may slow down or stop the growth of cancer, and may also
help to reduce its size.

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
If you have any doubts, ask your doctor before taking this medicine.
Lung or respiratory problems
Sometimes TEPMETKO can cause sudden breathing difficulties, which may be associated with fever and
cough. Tell your doctor immediately if you experience new or worsening symptoms
(see section 4), which could be signs of a serious lung disease (interstitial lung disease) that requires immediate medical attention. Your doctor may need to treat you
with other medicines and stop treatment with TEPMETKO.
Monitoring of liver function
Your doctor will perform blood tests to check your liver function before starting
treatment with TEPMETKO and, if necessary, during treatment.
Monitoring of heart function
If necessary, your doctor may perform an ECG during treatment to check if
TEPMETKO affects your heart rhythm.
Contraception
This medicine should not be used during pregnancy as it can cause harm to the unborn baby.
Patients of both sexes must use effective contraceptive measures during treatment with
TEPMETKO and for at least 1 week after the last dose. Your doctor will advise you on the most
suitable contraceptive methods. See below “Pregnancy”.

Children and adolescents
This medicine has not been studied in patients under 18 years of age.

Other medicines and TEPMETKO
Tell your doctor if you are taking, have recently taken or might take any other medicines.
TEPMETKO can 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 high blood pressure
• everolimus - used to treat cancer
• sirolimus - used to prevent organ rejection in transplant patients
• rosuvastatin - used to treat high levels of fats in the blood
• 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 your
doctor advises you to. This medicine can cause harm to the unborn baby. A pregnancy test is recommended before starting treatment with
TEPMETKO.
Contraception in men and women
If you are a woman who can become pregnant, you must use effective contraceptive methods to avoid
pregnancy during treatment with TEPMETKO and for at least 1 week after the last dose.
Tell your doctor if you are taking hormonal contraceptives (e.g. the “pill”), as you will need to use
a second method of contraception during this period.
If you are a man, you must use a barrier method of contraception to avoid pregnancy of 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. 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 lactose monohydrate in each tablet. If you have been
diagnosed with intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take TEPMETKO

Take this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor.
The recommended dose is 2 TEPMETKO tablets, to be taken orally once a day.
You may continue to take this medicine every day 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 a day, or to interrupt the
treatment for a few days.
Take the tablets with food or shortly after a meal, swallow them whole and without chewing. This
will ensure that the full dose enters the body.
If you have difficulty swallowing the tablets, you can mix them with water:

• Place the tablets in a glass without crushing them.
• Add 30 mL (equivalent to two tablespoons) of natural (non-carbonated) water - do not use other liquids.
• Mix until the tablets disintegrate into very small pieces. This may take a few minutes - the tablet will not dissolve completely.
• Drink the liquid within one hour.
• To ensure you have taken the full dose of the medicine, rinse the glass thoroughly with another 30 mL of water and drink the contents immediately.

If you have a nasogastric tube (NG) of 8 French or greater:

• Disperse the tablets in 30 mL of non-carbonated water as described above.
• Administer the liquid within 1 hour as instructed by the NG tube manufacturer.
• To ensure you have taken the full dose of the medicine, rinse the glass and syringe twice with another 30 mL of water each time to ensure that no trace of the medicine remains in the glass or syringe and that the full dose is administered.

If you take more TEPMETKO than you should
Experience with TEPMETKO overdose is limited. Symptoms of an
overdose are most likely to be similar to those listed under “Possible side effects” (see
paragraph 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
scheduled 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 a missed dose.
If you have any questions about using 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 immediately if you develop new or worsening symptoms such as
sudden difficulty breathing, 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
See your doctor if you experience any other side effects, including:
Very common side effects (may affect more than 1 in 10 people)

• Swelling caused by fluid retention in the body (edema)
• Nausea or vomiting
• Diarrhea
• Increased levels of creatinine in the blood (sign of possible kidney problems)
• Increased levels of alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase in the blood (sign of possible liver problems)
• Increased levels of amylase or lipase in the blood (sign of possible digestive problems)
• Decreased levels of albumin (a protein) in the blood

Common side effects (may affect up to 1 in 10 people)

• Change in the electrical activity of the heart observed on ECG (QT prolongation)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system listed in Annex V. By reporting side effects you can help
to 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 pack after Scad 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 any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This 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 of tepotinib (as tepotinib hydrochloride hydrate).
• The other components are mannitol, anhydrous colloidal silica, crospovidone, magnesium stearate and microcrystalline cellulose in the tablet core, and hypromellose, lactose monohydrate (see section 2, “TEPMETKO contains lactose”), macrogol, triacetin, red iron oxide (E172) and titanium dioxide (E171) in the film coating.

Description of the appearance of TEPMETKO and contents of the pack
TEPMETKO film-coated tablets are white-pink in colour, oval in shape,
biconvex, approximately 18x9 mm in size, with the letter “M” imprinted on one side and smooth
on the other. Each pack contains 60 tablets in transparent blisters, composed of a shaped foil
in a multilayer composite, with an aluminium cover.

Marketing Authorisation Holder
Merck Europe B.V.
Gustav Mahlerplein 102
1082 MA Amsterdam
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 .