Patient Medication Information: uses, side effects, how to take - Tepmetko
What is TEPMETKO used for?
TEPMETKO is used to treat a type of lung cancer called non-small cell lung cancer (NSCLC). It is used in adults:
whose cancer has spread to other parts of the body or is advanced and
cannot be removed by surgery, and
whose tumours have a change (abnormality) in the “MET” gene (known as the
mesenchymal epithelial transition gene).
Your healthcare professional will perform a test to make sure that TEPMETKO is right for you.
How does TEPMETKO work?
TEPMETKO belongs to a group of cancer medicines called MET tyrosine kinase inhibitors. A change in the MET gene can produce a protein that causes cancer cells to grow. TEPMETKO works by blocking this protein. This may slow or stop the cancer from growing. It may also help
Serious Warnings and Precautions
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to shrink the cancer.
What are the ingredients in TEPMETKO?
Medicinal ingredient: tepotinib (as tepotinib hydrochloride)
Non-medicinal ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, red iron oxides (E172), titanium dioxide, triacetin.
TEPMETKO comes in the following dosage forms:
Tablets, 225 mg tepotinib (as tepotinib hydrochloride)
Do not use TEPMETKO if:
- you are allergic to tepotinib or any of the other ingredients of this medicine. Talk to your healthcare professional if you are not sure.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TEPMETKO. Talk about any health conditions or problems you may have, including if you:
- have or have had problems with your kidney
- have or have had problems with your liver
- have an allergy to lactose. This is because TEPMETKO contains lactose.
Other warnings you should know about:
Pregnancy and breastfeeding:
Female patients:
- If you are pregnant, able to get pregnant or think you are pregnant, there are specific risks you should discuss with your healthcare professional.
- You should not take TEPMETKO if you are pregnant. It can harm your unborn baby.
If you are able to become pregnant:
- Your healthcare professional should do a pregnancy test before you start treatment with TEPMETKO.
- Avoid becoming pregnant while you are taking TEPMETKO. Use effective birth control during treatment and for 1 week after your final dose of TEPMETKO. Talk to your healthcare professional about birth control methods that may be right for you during this time.
- Tell your healthcare professional right away if you become pregnant or think you may be pregnant during treatment with TEPMETKO
- Do NOT breastfeed during treatment and for 1 week after your final dose of TEPMETKO. It is not known if TEPMETKO passes into your breast milk. Talk to your healthcare professional about the best way to feed your baby during this time.
Male patients with female partners who can become pregnant:
- You should not father a child while taking TEPMETKO. It may harm your unborn baby.
- Use condoms each time you have sex while taking TEPMETKO and for 1 week following your final dose.
- If your partner becomes pregnant while you are taking TEPMETKO, tell your healthcare professional right away.
Fertility:
It is unknown whether TEPMETKO may affect your fertility. No human studies on fertility have been performed. Talk to your healthcare professional if you have questions about this.
Driving and using machines:
Before you do tasks that require special attention, wait until you know how you respond to TEPMETKO.
Children and adolescents: TEPMETKO is NOT approved for use in children and adolescents under the age of 18 years.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with TEPMETKO:
- Digoxin – used to treat heart conditions
How to take TEPMETKO:
- Take TEPMETKO exactly as your healthcare professional tells you to take it. Check with your doctor, pharmacist or nurse if you are not sure.
- Do NOT change your dose or stop taking it unless your healthcare professional tells you to.
Take TEPMETKO 1 time a day with food.
- Take it at about the same time each day
- If your daily dose consists of more than one tablet, take both tablets together at the same time as a single dose.
- Swallow tablets whole. Do NOT chew, crush or split tablets.
Usual dose:
Usual adult dose:
450 mg (two 225 mg tablets) by mouth once a day.
Your healthcare professional may change your dose, interrupt, or permanently stop treatment with TEPMETKO. This may happen if you develop certain side effects or if your disease gets worse.
Overdose:
| If you think you, or a person you are caring for, have taken too much TEPMETKO, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
- If you miss a dose and it is more than 8 hours until your next dose, take the missed dose with food as soon as you remember. Continue with your next dose at your regular time.
- If it is within 8 hours of your next dose, skip the missed dose. Wait and take your next dose at your regular time. Do NOT take a double dose to make up for the missed dose.
- If you vomit after taking TEPMETKO, wait and take the next dose at your next scheduled time. Do not take an extra dose.
What are possible side effects from using TEPMETKO?
These are not all the possible side effects you may feel when taking TEPMETKO. If you experience any side effects not listed here, contact your healthcare professional.
- swelling of your face or other parts of your body
- fatigue, weakness, dizziness, headache
- nausea, vomiting
- diarrhea, constipation
- stomach pain
- decreased appetite
- muscle, bone or joint pain
- fever
- rash, itching
- shortness of breath
TEPMETKO can cause abnormal blood test results. Your healthcare professional will perform blood tests before and during your treatment. Your doctor will interpret the results.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON | |||
Liver problems (increased liver enzymes): loss of appetite, nausea, vomiting, yellowing of your skin and/or the white part of your eyes (jaundice), dark “tea-coloured” urine, confusion, sleepiness, weakness, pain on the upper right side of stomach, swelling in your stomach area, light-coloured stools (bowel movements) | X | ||
| Pleural effusion (fluid around the lungs): chest pain, difficult or painful breathing, cough | X | ||
| Pneumonia (infection in the lungs): chest pain when you breath or cough, confusion, cough which may produce phlegm, fatigue, fever, sweating, severe shivering with chills, nausea, vomiting or diarrhea, shortness of breath | X | ||
| COMMON | |||
| Acute kidney injury (severe kidney problems): confusion; itchiness or rashes; puffiness in your face and hands; swelling in your feet or ankles; urinating less or not at all; weight gain | X | ||
| Interstitial lung disease / Pneumonitis (inflammation or scarring of the lungs): new or worsening lung problems, including: trouble breathing, shortness of breath, cough, wheezing, fever | X | ||
| Severe swelling, including generalized edema (swelling affecting the whole body) | X | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store at room temperature between 15 to 30°C. Keep in the original package to protect from moisture.
Keep out of reach and sight of children.
If you want more information about TEPMETKO:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html) or the EMD Serono website (http://www.emdserono.ca).
Last Revised:
MAR 4, 2024