225 mg film-coated tablets
tepotinib
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 with surgery. This medicine is given when the cancer cells have a change in a gene called MET (mesenchymal-epithelial transition factor) and previous treatment has not helped to stop the disease.
A change in the MET gene can lead to the formation of an abnormal protein, which can then lead to uncontrolled cell growth and cancer. By blocking the effect of the abnormal protein, TEPMETKO can delay or stop cancer growth. It can also help shrink cancer.
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 and breathing problems
TEPMETKO can sometimes lead to sudden breathing problems which may be associated with fever and cough. Tell your doctor immediately if you develop new or worsening symptoms (see section 4) as these may be signs of a serious lung disease (interstitial lung disease) that needs to be treated immediately. The doctor may need to treat you with other medicines and interrupt the treatment with TEPMETKO.
Control of liver function
The doctor will take blood samples to check how well your liver is working before you receive treatment with TEPMETKO and, if necessary, during treatment.
Control of heart function
If necessary, the doctor will perform ECG examinations during treatment to check whether TEPMETKO affects your heart rhythm.
Contraceptive
This medicine should not be used during pregnancy as it may harm the unborn baby. Men and women should use effective contraception during treatment with TEPMETKO and for at least 1 week after the last dose. The doctor will advise you on suitable contraceptives. See “Pregnancy” below.
Children and young people
This medicine has not been studied in patients under 18 years of age.
Other medicines and TEPMETKO
Tell your doctor if you are using, have recently used, or might be using other medicines.
The following medicines can affect how well TEPMETKO works:
- carbamazepine – used to treat epileptic seizures or nerve pain
- phenytoin – used to treat epileptic seizures
- rifampicin – used to treat tuberculosis (TB)
- St. John’s wort – a natural remedy used to treat mild depression
- itraconazole or ketoconazole – used to treat fungal infections
- ritonavir, saquinavir or nelfinavir – used to treat HIV infection
- quinidine or verapamil – is used to treat irregular heart rhythms.
TEPMETKO can affect how well the following medicines work and/or increase the side effects of these medicines:
- dabigatran – used to prevent stroke or venous thrombosis/pulmonary embolism
- digoxin – used to treat irregular heartbeats 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 blood lipids
- methotrexate – used to treat inflammatory diseases or cancer
- topotecan – used to treat cancer
- metformin – is used to treat diabetes.
Pregnancy and breastfeeding
Pregnancy
Do not take TEPMETKO if you are pregnant or think you may be pregnant unless your doctor has told you to. This medicine may harm the unborn baby. A pregnancy test is recommended before starting treatment with TEPMETKO.
Contraceptives for men and women
If you are a woman of childbearing potential, you must use effective contraception to avoid pregnancy during treatment with TEPMETKO and for at least 1 week after the last dose. Talk to your doctor if you are taking hormonal contraceptives (e.g. birth control pills ) as you will need to use an additional contraceptive during this time.
If you are a man, you should use a barrier method to prevent your partner from becoming pregnant during treatment with TEPMETKO and for at least 1 week after the last dose.
The doctor will advise you on suitable contraceptives.
Breast-feeding
It is not known whether TEPMETKO is passed to the baby through breast milk. Stop breastfeeding your child during treatment with this medicine and for at least 1 week after the last dose.
Driving ability and use of machinery
TEPMETKO does not influence the ability to drive or use machines.
TEPMETKO contains lactose
TEPMETKO contains 4.4 mg lactose monohydrate per tablet. If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
How to take TEPMETKO
Always take this medicine as directed by your doctor. Consult a doctor if you are unsure.
The recommended dose is 2 tablets of TEPMETKO taken by mouth once a day. You can continue to take this medicine daily as long as you benefit from it and do not experience side effects that you do not tolerate. In case of severe side effects, the doctor may advise you to reduce the dose by one to 1 tablet daily or to interrupt the treatment for a few days.
Take the tablets with food or shortly after a meal, and swallow them whole without chewing. This ensures that the entire dose reaches your system.
If you have taken too much TEPMETKO
The experience of overdose with TEPMETKO is limited. The symptoms of overdose are expected to be similar to the side effects listed under “Possible side effects” (see section 4). Talk to your doctor if you have taken too much TEPMETKO.
If you forget to take TEPMETKO
If you have forgotten a dose of TEPMETKO, take it as soon as you remember. If you are due to take the next dose within 8 hours, skip the missed dose and take the next dose at your usual time. Do not take a double dose to make up for a missed dose.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Lung and breathing problems
Tell your doctor immediately if you develop new or worsening symptoms such as sudden difficulty breathing, cough, or fever. These may be signs of a serious lung disease (interstitial lung disease) that needs to be treated immediately. This side effect is common (may affect up to 1 in 10 users).
Other side effects are
Talk to your doctor if you get other side effects. These may include:
Very common side effects (may affect more than 1 in 10 users)
- Swelling is caused by the accumulation of fluid in the body ( edema )
- Nausea or vomiting
- Diarrhea
- Increased levels of creatinine in the blood (a sign of possible kidney problems)
- Elevated 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)
- Decreased levels of protein and albumin in the blood
Common side effects (may affect up to 1 in 10 users)
- Change in the electrical activity of the heart as seen on the ECG ( QT prolongation)
How TEPMETKO should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is tepotinib. Each film-coated tablet contains 225 mg of tepotinib (as a hydrochloride hydrate).
- Other ingredients are mannitol, colloidal anhydrous 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.
Appearance and package sizes of the medicine
TEPMETKO film-coated tablets are white-pink, oval, biconvex, approximately 18×9 mm in size and debossed with “M” on one side and plain on the other side. Each package contains 60 tablets in a transparent blister consisting of a multi-layered foil and an aluminum lid.
Marketing Authorisation Holder
Merck Europe BV
Gustav Mahlerplein 102
1082 MA Amsterdam
Netherlands
Manufacturer
Merck Healthcare KGaA
Frankfurter Strasse 250
64293 Darmstadt
Germany