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Generated Narrative: Bundle TEST PURPOSES ONLY - tukysa

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Generated Narrative: MedicinalProductDefinition mp31b0725ade6496816df8ac216511de2c

identifier: http://ema.europa.eu/identifier/TUKYSA 50 mg film-coated tablets: EU/1/20/1526/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

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productName: TUKYSA 50 mg film-coated tablets

type: Full name

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part: nan

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Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-31b0725ade6496816df8ac216511de2c

identifier: http://ema.europa.eu/identifier/TUKYSA 50 mg film-coated tablets: EU/1/20/1526/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - tukysa

Attesters

What is in this leaflet

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

What TUKYSA is TUKYSA is a medicine for breast cancer. It contains the active substance tucatinib and it belongs to a group of medicines called protein kinase inhibitors which prevent the growth of some types of cancer cells in the body.

What TUKYSA is used for TUKYSA is used for adults who have breast cancer which:

• has a receptor (target) on the cancer cells called human epidermal growth factor receptor 2 (HER2-positive breast cancer)
• has spread beyond the original tumour or to other organs such as the brain or cannot be removed by surgery
• has previously been treated with certain other breast cancer treatments

TUKYSA is taken with two other cancer medicines, trastuzumab and capecitabine. Separate patient information leaflets are available for these medicines. Ask your doctor to tell you about them.

How TUKYSA works TUKYSA works by blocking the HER2 receptors on cancer cells. HER2 produces signals that can help the cancer to grow, and blocking it may slow or stop cancer cells from growing or may kill them altogether.

Do not take TUKYSA

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

Warnings and precautions

• Talk to your doctor before taking TUKYSA if you have liver problems. During your treatment, your doctor will run tests to check that your liver is working properly.

• TUKYSA can cause severe diarrhoea. Talk to your doctor right away at the first sign of diarrhoea (loose stool) and if your diarrhoea persists with nausea and/or vomiting.

• TUKYSA may cause harm to an unborn baby when taken by a pregnant woman. Talk to your doctor before you take TUKYSA if you think you may be pregnant or are planning to have a baby. See section on Pregnancy and breast-feeding below.

Children and adolescents TUKYSA should not be used in children under the age of 18 years. The safety of TUKYSA and how effective it is has not been studied in this age group.

Other medicines and TUKYSA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines may affect the way TUKYSA works or TUKYSA may affect the way they work. These medicines include some medicines in the following groups:

• St John s wort a herbal product used to treat depression
• itraconazole, ketoconazole, voriconazole, posaconazole used to treat fungal infections
• rifampicin used to treat bacterial infections
• darunavir, saquinavir, tipranavir used to treat HIV
• phenytoin, carbamazepine used to treat epilepsy or a painful condition of the face called trigeminal neuralgia or to control serious mood disorder when other medicines do not work
• buspirone used to treat certain mental health problems
• sirolimus, tacrolimus used to control your body s immune response after a transplant
• digoxin used to treat heart problems
• lomitapide, lovastatin used to treat abnormal cholesterol levels
• alfentanil used for pain relief
• avanafil, vardenafil used to treat erectile dysfunction
• darifenacin used to treat urinary incontinence
• midazolam, triazolam used to treat seizures, anxiety disorders, panic, agitation, and insomnia
• repaglinide used to treat type 2 diabetes
• ebastine an antihistamine used to treat seasonal and perennial allergic rhinitis and rhino-conjunctivitis.
• everolimus, ibrutinib used to treat certain cancers
• naloxegol used to treat to treat constipation

Pregnancy and breast-feeding TUKYSA may cause harmful effects to an unborn baby when taken by a pregnant woman. Your doctor will do a pregnancy test before you start taking TUKYSA.

• If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. The doctor will weigh the potential benefit to you against the risk to the unborn baby.
• Use a reliable method of contraception to avoid becoming pregnant while you are taking TUKYSA and for at least 1 week after the last dose.
• If you are male and have a female sexual partner who can become pregnant, use a reliable method of contraception to avoid pregnancy while you are taking TUKYSA and for at least 1 week after the last dose.
• If you become pregnant during treatment with TUKYSA, tell your doctor. The doctor will assess the potential benefit to you of continuing this medicine and the risk to the unborn baby.

It is not known whether TUKYSA passes into breast milk.

• If you are breast feeding or planning to breast feed, ask your doctor for advice before taking this medicine. You should not breastfeed during treatment with TUKYSA and for at least 1 week after the last dose. Talk to your doctor about the best way to feed your baby during treatment.

Ask your doctor or pharmacist for advice before taking TUKYSA if you have any questions.

Driving and using machines TUKYSA is not expected to affect your ability to drive or operate machines. However, you are responsible for deciding whether you can drive a motor vehicle or perform other tasks that require increased concentration.

TUKYSA contains sodium and potassium This medicine contains 55.3 mg sodium (main component of cooking/table salt) in each 300 mg dose. This is equivalent to 2.75% of the recommended maximum daily dietary intake of sodium for an adult.

This medicine contains 60.6 mg potassium per 300 mg dose. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Dosage The recommended dose is 300 mg (two 150 mg tablets) by mouth twice a day.

Your doctor may change your dose of TUKYSA if you experience certain side effects. To allow for a lower dose, your doctor may prescribe 50 mg tablets.

Method of administration TUKYSA can be taken with food or between meals.

• Swallow the tablets whole, one after the other.
• Take each dose about 12 hours apart at the same times every day.
• Do not chew or crush the tablet.
• Do not take an additional dose if you vomit after taking TUKYSA but continue with the next scheduled dose.

If you take more TUKYSA than you should
Talk to a doctor or pharmacist straight away. If possible, show them the pack.

If you forget to take TUKYSA
Do not take a double dose to make up for a forgotten dose. Just take the next dose at the scheduled time.

If you stop taking TUKYSA
TUKYSA is for long-term treatment and you should take it continuously. Do not stop taking TUKYSA without talking to your doctor.

While you are taking TUKYSA

• Depending on the side effects you have, your doctor may recommend lowering your dose or temporarily stopping your treatment.
• Your doctor will also check your liver function during treatment with TUKYSA.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine.

Very common (may affect more than 1 in 10 people):

• diarrhoea;
• feeling sick (nausea);
• being sick (vomiting);
• mouth sores, inflammation of the mouth, mouth ulcers;
• liver problems, which may cause itching, yellowing of eyes and skin, dark urine and pain or discomfort in the upper right area of the stomach;
• rash;
• joint pain;
• weight loss;
• nosebleed

Tell your doctor or pharmacist if you notice any side effects.

Reporting of side effects Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

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 blister and the carton. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

What TUKYSA contains
The active substance is tucatinib. Each film-coated tablet contains either 50 mg or 150 mg tucatinib. The other ingredients are:

• Tablet core - copovidone, crospovidone, sodium chloride, potassium chloride, sodium hydrogen carbonate, silica, colloidal anhydrous, magnesium stearate, microcrystalline cellulose (see section 2 TUKYSA contains sodium and potassium ).
• Film-coating poly (vinyl alcohol), titanium dioxide, macrogol, talc, yellow iron oxide.

What TUKYSA looks like and contents of the pack
TUKYSA 50 mg film-coated tablets (tablets) are round, yellow and debossed with TUC on one side and 50 on the reverse side.
TUKYSA 150 mg film-coated tablets (tablets) are oval shaped, yellow, and debossed with TUC on one side and 150 on the reverse side.

TUKYSA is supplied in aluminium foil blisters. Each pack contains:
TUKYSA 50 mg film-coated tablets

• 88 tablets (11 blisters of 8 tablets each).
  TUKYSA 150 mg film-coated tablets
• 84 tablets (21 blisters of 4 tablets each).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Seagen B.V. Evert van de Beekstraat 1-1118CL Schiphol
The Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Seagen B.V. (Nederland/Pays-Bas/Niederlande) T l/Tel: +32 7848 27 Lietuva Swixx Biopharma UAB
Tel: +370 5 236 9
Swixx Biopharma EOOD
Te .: +359 2 4942 Luxembourg/Luxemburg Seagen B.V. (Pays-Bas/Niederlande) T l/Tel: +352 27 867 esk republika Swixx Biopharma s.r.o.
Tel: +420 242 434 Magyarorsz g Swixx Biopharma Kft. Tel.: +36 1 9206 Danmark Seagen Denmark ApS Tlf: +45 89 88 83 Malta Genesis Pharma (Cyprus) Ltd ( ipru/Cyprus) Tel: +357 22 765Deutschland Seagen Germany GmbH Tel: +49 893 803 6Nederland Seagen B.V. Tel: +31 202 419Eesti Swixx Biopharma O
Tel: +372 640 1Norge Seagen B.V. (Nederland) Tlf: +45 89 88 83
.
: +30 210 87 71 sterreich Seagen B.V. (Niederlande) Tel: (+43) 720 778Espa a Seagen Spain S.L.U. Tel: (+34) 919 011 Polska Swixx Biopharma Sp.z o.o. Tel.: +48 22 460 07 France Seagen France SAS T l: +33 184 88 80 Portugal Seagen B.V. (Pa ses Baixos) Tel: (+351) 211 451 Hrvatska Swixx Biopharma d.o.o.
Tel: +385 1 2078 Rom nia Swixx Biopharma S.R.L. Tel: +40 371 530 Ireland Seagen B.V. (Netherlands) Tel: +353 1903 9Slovenija Swixx Biopharma d.o.o.
Tel: +386 1 2355 sland Seagen B.V. (Holland) S mi: +354 539 0Slovensk republika Swixx Biopharma s.r.o. Tel: +421 2 20833 Italia Seagen Italy S.r.l. Tel: (+39) 02 82952Suomi/Finland Seagen B.V. (Alankomaat/Nederl nderna) Puh/Tel: +358 753 252
Genesis Pharma (Cyprus) Ltd
: +357 22 765Sverige Seagen B.V. (Nederl nderna) Tel: (+46) 108 885 Latvija Swixx Biopharma SIA
Tel: +371 6 6164 United Kingdom (Northern Ireland) Seagen B.V. (Netherlands) Tel: +44 330 818 0This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: