Tabrecta 150 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Tabrecta 150 mg film-coated tablets
Tabrecta 200 mg film-coated tablets

capmatinib

This medicine is subject to additional monitoring, which will allow quicker detection of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is provided at the end of section 4.

Read this entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if the side effects are not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Tabrecta is and what it is used for

What Tabrecta is

Tabrecta contains the active substance capmatinib, which belongs to a group of medicines called protein kinase inhibitors.

What Tabrecta is used for

Tabrecta is a medicine used to treat adult patients with a type of lung cancer called non-small cell lung cancer (NSCLC). It is used if the lung cancer is advanced or has spread to other parts of the body (metastatic) and is caused by a change (mutation) in a gene that produces an enzyme called MET.

You will undergo tests on your tumor or blood to detect certain mutations in this gene. If the result is positive, your cancer may respond to treatment with Tabrecta.

How Tabrecta works

Tabrecta helps slow down or stop the growth and spread of lung cancer if it is caused by a mutation in a gene that produces MET.

If you have any questions about how Tabrecta works or why this medicine has been prescribed for you, consult your doctor or pharmacist.

2. What you need to know before taking Tabrecta

Do not take Tabrecta

• if you are allergic to capmatinib or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Tabrecta:

• if you have or have had lung problems or breathing difficulties unrelated to lung cancer.
• if you have or have had liver problems.
• if you have or have had pancreatic problems.

While taking Tabrecta, you should limit direct exposure to sunlight or artificial ultraviolet (UV) light. You should use sunscreen, wear sunglasses and protective clothing, and avoid sun exposure while taking Tabrecta and for at least 7 days after stopping treatment.

Tell your doctor, pharmacist, or nurse immediately if you experience an allergic reaction during treatment with Tabrecta:

• Symptoms of an allergic reaction may include rash, hives, fever, difficulty breathing, or low blood pressure.

Monitoring during treatment with Tabrecta

Your doctor will perform blood tests before starting treatment with Tabrecta to check liver and pancreas function. Your doctor will continue to monitor liver and pancreas function during treatment with Tabrecta.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age, as it has not yet been studied in this age group.

Other medicines and Tabrecta

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

It is particularly important that you mention any of the following medicines:

• medicines used to treat seizures such as carbamazepine, phenobarbital, phenytoin
• St. John’s wort (also known as Hypericum perforatum), a herbal product used to treat depression and other conditions
• medicines used to treat tuberculosis, such as rifampicin
• antibiotics used to treat bacterial infections, such as telithromycin, clarithromycin
• medicines used to treat fungal infections, such as ketoconazole, itraconazole, posaconazole, voriconazole
• medicines used to treat HIV/AIDS, such as ritonavir (either alone or in combination with lopinavir), saquinavir, indinavir, nelfinavir, efavirenz
• medicines used to treat hepatitis, such as telaprevir
• medicines used to treat depression, such as nefazodone
• medicines used to treat high blood pressure or heart problems, such as verapamil
• medicines used to treat respiratory problems, such as theophylline
• medicines used to treat muscle spasms, such as tizanidine
• medicines used to treat heart conditions, such as digoxin
• medicines used to treat blood clots, such as dabigatran etexilate
• medicines used to treat gout, such as colchicine
• medicines used to treat diabetes, such as sitagliptin, saxagliptin
• medicines used to treat high cholesterol, such as rosuvastatin, pravastatin
• medicines used to treat certain types of cancer or autoimmune diseases, such as methotrexate, mitoxantrone
• sulfasalazine, a medicine used to treat inflammation in the intestine and rheumatoid arthritis

Talk to your doctor, pharmacist, or nurse if you are unsure whether you are taking any of the medicines listed above.

You should also inform your doctor if you are prescribed a new medicine while already being treated with Tabrecta.

Pregnancy and breastfeeding

Tabrecta can harm an unborn baby. If you are a woman who could become pregnant, your doctor will perform a pregnancy test before starting treatment with Tabrecta to make sure you are not pregnant. You must use an effective method of contraception while taking Tabrecta and for at least 7 days after stopping treatment to prevent pregnancy. Talk to your doctor about effective contraceptive methods.

If you become pregnant or think you may be pregnant while taking Tabrecta, inform your doctor immediately. Your doctor will discuss with you the potential risks of taking Tabrecta during pregnancy.

If you are a man with a partner who is pregnant or who could become pregnant, you must use condoms while taking Tabrecta and for at least 7 days after stopping treatment.

It is not known whether Tabrecta passes into breast milk. You must not breastfeed while taking Tabrecta and for at least 7 days after stopping treatment.

Driving and using machines

Tabrecta is not expected to affect your ability to drive or use machines.

Tabrecta contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; that is, essentially “sodium-free”.

3. How to take Tabrecta

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Do not take more than the recommended dose prescribed by your doctor.

How much Tabrecta to take

The recommended dose is 400 mg (2 tablets of 200 mg) taken orally twice daily, with or without food. Taking Tabrecta twice daily at the same time each day will help you remember when to take your medicine. If you have difficulty swallowing the tablets, take Tabrecta tablets with food.

Your doctor will tell you exactly how many Tabrecta tablets you should take. Your doctor may adjust the dose during treatment with Tabrecta if you experience certain adverse effects. Do not change the dose without speaking to your doctor.

Take Tabrecta tablets whole. Do not break, chew, or crush the tablets.

If you vomit after taking Tabrecta, do not take another dose until it is time for your next scheduled dose.

How long to take Tabrecta

Continue taking Tabrecta for as long as your doctor instructs.

This is a long-term treatment, which may last for months or years. Your doctor will monitor your condition to ensure the treatment is having the desired effect.

If you have any questions about how long you should take Tabrecta, consult your doctor or pharmacist.

If you take more Tabrecta than you should

If you have taken too many Tabrecta tablets, or if someone accidentally takes your medicine, contact your doctor or hospital immediately. You should show them the Tabrecta packaging. Medical treatment may be necessary.

If you forget to take Tabrecta

Do not take a double dose to make up for missed doses. Wait until it is time to take your next dose.

If you stop taking Tabrecta

Your doctor may temporarily or permanently discontinue treatment with Tabrecta if you experience certain adverse effects. Do not stop taking your medicine unless instructed by your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can produce adverse effects, although not everyone experiences them.

Some adverse effects may be serious

If you experience any of the serious adverse effects listed below, inform your doctor immediately. They may advise you to stop taking the medicine or may adjust your dose.

Very common: may affect more than 1 in 10 people

• Abnormal blood test results, such as high levels of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST), which may be a sign of liver problems
• Abnormal blood test results, such as high levels of amylase and/or lipase, which may be a sign of pancreatic problems

Common: may affect up to 1 in 10 people

• Abnormal blood test results, such as high bilirubin levels, which may be a sign of liver problems
• Cough, fever, breathing difficulties, shortness of breath, or wheezing, which may be signs of lung inflammation (pneumonitis, interstitial lung disease)
• Urinating less frequently than usual or passing smaller amounts of urine than normal, which may be a sign of kidney problems (renal failure, acute kidney injury)

Uncommon: may affect up to 1 in 100 people

• Severe upper abdominal pain, which may be a sign of inflammation of the pancreas (acute pancreatitis)
• Allergic reaction (hypersensitivity) that may include rash, hives, fever, difficulty breathing, or low blood pressure

Other possible adverse effects

Other adverse effects include the following list. If any of these adverse effects become severe, inform your doctor, pharmacist, or nurse.

Very common: may affect more than 1 in 10 people

• Swelling in the hands, elbows, or feet (peripheral edema)
• Nausea and/or vomiting
• Tiredness and/or weakness (fatigue, asthenia)
• Shortness of breath (dyspnea)
• Loss of appetite
• Back pain
• Cough
• Changes in bowel movements (diarrhea or constipation)
• Weight loss
• Fever (pyrexia)
• Itching without rash (pruritus)
• Skin rash

Common: may affect up to 1 in 10 people

• Chest pain
• Pain, tenderness, redness, warmth, or swelling of the skin, which may be a sign of bacterial skin infection (cellulitis)
• Itching with rash (urticaria)

Abnormal blood test results

During treatment with Tabrecta, blood test results may be abnormal, which could indicate problems with the kidneys, liver, or electrolytes. These include the following:

Very common: may affect more than 1 in 10 people

• Low blood albumin levels
• High blood creatinine levels (a substance excreted by the kidneys)
• Low blood phosphate levels
• Low blood sodium levels

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Tabrecta Storage

• 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 the month indicated.
• This medicine does not require any special storage temperature. Store in the original packaging to protect it from moisture.
• Do not use this medicine if you notice any damage to the packaging or signs of tampering.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tabrecta

• The active substance is capmatinib.
• Each 150 mg film-coated tablet contains capmatinib dihydrochloride monohydrate equivalent to 150 mg of capmatinib.
• Each 200 mg film-coated tablet contains capmatinib dihydrochloride monohydrate equivalent to 200 mg of capmatinib.
• Other components are:
• Tablet core: microcrystalline cellulose; mannitol; crospovidone; povidone; magnesium stearate; anhydrous colloidal silica; sodium lauryl sulfate (see “Tabrecta contains sodium” in section 2).
• Coating (150 mg): hypromellose; titanium dioxide (E171); macrogol; talc; iron oxide, yellow (E172); iron oxide, red (E172); iron oxide, black (E172).
• Coating (200 mg): hypromellose; titanium dioxide (E171); macrogol; talc; iron oxide, yellow (E172).

Appearance of Tabrecta and contents of the pack

Tabrecta 150 mg film-coated tablets (tablets) are light orange-brown, oval-shaped tablets. They are marked with “DU” on one side and “NVR” on the other. Approximate size: 18.3 mm (length) x 7.3 mm (width).

Tabrecta 200 mg film-coated tablets (tablets) are yellow, oval-shaped tablets. They are marked with “LO” on one side and “NVR” on the other. Approximate size: 20.3 mm (length) x 8.1 mm (width).

Tabrecta film-coated tablets are supplied in blisters and are available in pack sizes containing 60 or 120 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer

Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava
Slovenia

Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nürnberg
Germany

Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain

Novartis Pharmaceuticals S.R.L.
Str. Livezeni nr. 7A
540472 Targu Mures
Romania

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu