Tabrecta

Patient Information Leaflet

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

capmatinib
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. 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 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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 class 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 when the lung cancer is at an advanced stage 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 a test of your tumour or blood to detect specific mutations in this gene. If the test result is positive, your cancer is likely to respond to treatment with Tabrecta.

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

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

2. What you should 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 or breathing problems other than lung cancer
• if you have or have had liver problems
• if you have or have had pancreas problems.

While using Tabrecta, limit your exposure to direct sunlight or artificial ultraviolet (UV) light.
While taking Tabrecta and for at least 7 days after stopping treatment, use sunscreen, wear sunglasses and protective clothing, and avoid sun exposure.
Contact 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
Before starting treatment with Tabrecta, your doctor will perform blood tests to check liver and pancreas function. During treatment with Tabrecta, your doctor will continue to monitor these functions.
Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, as it has not been studied in this age group.
Other medicines and Tabrecta
Inform your doctor or pharmacist if you are taking, have recently taken, or might 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 (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 problems, 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 intestinal inflammation and rheumatic joint inflammation

Ask your doctor, pharmacist, or nurse if you are unsure whether you are taking any of the medicines listed above.
Also inform your doctor if you are prescribed a new medicine while already taking Tabrecta.
Pregnancy and breastfeeding
Tabrecta may harm an unborn baby. If you are a woman of childbearing age, your doctor will perform a pregnancy test before starting treatment with Tabrecta to make sure you are not pregnant. While taking Tabrecta and for at least 7 days after stopping treatment, you must use an effective method of contraception to prevent pregnancy. Ask your doctor for advice on effective contraceptive methods.
If you become pregnant or suspect you are 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 pregnant partner or a partner who could become pregnant, you must use a condom while taking Tabrecta and for at least 7 days after stopping treatment.
It is not known whether Tabrecta passes into breast milk. Do not breastfeed while taking Tabrecta and for at least 7 days after stopping treatment.
Driving and using machines
Tabrecta is not expected to affect the ability to drive vehicles or operate machinery.
Tabrecta contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How to take Tabrecta

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Do not exceed the recommended dose prescribed by your doctor.
How much Tabrecta to take
The recommended dose is 400 mg (two 200 mg tablets) taken orally twice daily,
with or without food. Take Tabrecta twice daily at approximately the same time each day, as this
will help you remember when to take the medicine. If you have difficulty swallowing the tablets, take the
Tabrecta tablets with food.
Your doctor will tell you exactly how many Tabrecta tablets to take. If you experience certain
adverse effects during treatment with Tabrecta, your doctor may adjust the dose. Do not change the dose without first discussing it with your doctor.
Swallow Tabrecta tablets whole. Do not break, chew, or crush the tablets.
If you vomit after taking Tabrecta, do not take additional Tabrecta tablets until your next scheduled dose.
How long to take Tabrecta
Continue taking Tabrecta for as long as your doctor tells you to.
This is a long-term treatment, which may last for months or years. Your doctor will monitor your
condition to assess whether 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 much Tabrecta, or if someone else accidentally takes your medicine, contact
a doctor or hospital immediately for advice. Show the Tabrecta packaging. Medical treatment may be necessary.
If you forget to take Tabrecta
Do not take a double dose to make up for a missed dose. Instead, wait until the time for your next dose.
If you stop taking Tabrecta
If you experience certain adverse effects, your doctor may temporarily or permanently discontinue
treatment with Tabrecta. Do not stop taking this medicine unless instructed to do so by your doctor.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Some side effects can be serious
If you experience any of the serious side effects listed below, contact your doctor immediately.
Your doctor may decide to stop treatment with this medicine or adjust the dose.

Very common: may occur in more than 1 out of 10 people

• abnormal blood tests, such as elevated levels of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST), which may indicate liver problems
• abnormal blood tests, such as elevated levels of amylase and/or lipase, which may indicate pancreatic problems

Common: may occur in up to 1 out of 10 people

• abnormal blood tests, such as elevated levels of bilirubin, which may indicate liver problems
• cough, fever, breathing difficulties, shortness of breath, or wheezing, which may indicate lung inflammation (pneumonitis, interstitial lung disease)
• less frequent urination than normal or passing smaller amounts of urine than normal, which may indicate kidney problems (renal failure, acute kidney injury)

Uncommon: may occur in up to 1 out of 100 people

• severe pain in the upper abdomen, which may indicate inflammation of the pancreas (acute pancreatitis)
• allergic reaction (hypersensitivity) which may include rash, hives, fever, breathing difficulties, or low blood pressure

Other side effects
Other side effects include those listed below. If these side effects become severe, contact your doctor, pharmacist, or nurse.

Very common: may occur in more than 1 out of 10 people

• swollen hands, ankles, or feet (peripheral oedema)
• nausea and/or vomiting
• tiredness and/or weakness (fatigue, asthenia)
• shortness of breath (dyspnoea)
• loss of appetite
• back pain
• cough
• changes in bowel habits (diarrhoea or constipation)
• weight loss
• fever (pyrexia)
• itching sensation without rash
• rash

Common: may occur in up to 1 out of 10 people

• chest pain
• pain, tenderness, redness, warmth, or swelling of the skin, which may indicate a bacterial skin infection (cellulitis)
• itching with rash (urticaria)

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

Very common: may occur in more than 1 out of 10 people

• low level of albumin in the blood
• high level of creatinine in the blood (a substance excreted by the kidney)
• low level of phosphate in the blood
• low level of sodium in the blood

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tabrecta

• 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 foil after "EXP". The expiry date refers to the last day of that month.
• This medicine does not require any special storage temperature. Store in the original packaging to protect the medicine from moisture.
• Do not use this medicine if you notice any damage to the packaging or signs of tampering.
• Do not dispose of any medicine 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 Tabrecta contains

• 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.
• The 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, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172)
• coating (200 mg): hypromellose, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172).

Description of the appearance of Tabrecta and package contents
Tabrecta 150 mg film-coated tablets (tablets) are pale orange-brown oval 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 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 Nuremberg
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:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf.: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

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