TUKYSA 150 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

TUKYSA 50mg film-coated tablets

TUKYSA 150mg film-coated tablets

tucatinib

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of the leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is TUKYSA and what is it used for

What is TUKYSA

TUKYSA is a medicine for breast cancer. It contains the active substance tucatinib and belongs to a group of medicines called kinase inhibitors that 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 that:

• has a receptor (target) on 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 been previously treated with other breast cancer treatments

TUKYSA is taken with two other cancer medicines, trastuzumab and capecitabine. There are separate package leaflets for patients about these medicines. Ask your doctorto tell you about them.

How TUKYSA works

TUKYSA works by blocking HER2 receptors on cancer cells. HER2 produces signals that can help cancer grow, and by blocking it, the growth of cancer cells can be slowed down or stopped, or they can be killed completely.

2. What you need to know before you take TUKYSA

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

• Tell your doctor before starting TUKYSA if you have liver problems. During treatment, your doctor will do tests to check that your liver is working properly.

• TUKYSA may cause severe diarrhoea. Tell your doctor immediately if you get the first sign of diarrhoea (loose stools) and if diarrhoea persists with nausea and/or vomiting.

• TUKYSA may harm your unborn baby when taken by a pregnant woman. Tell your doctor before starting TUKYSA if you think you might be pregnant or plan to become pregnant. See the section on “Pregnancy and breast-feeding” below.

Children and adolescents

TUKYSA should not be used in children under 18 years of age. The safety and efficacy of TUKYSA in this age group have not been established.

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 how TUKYSA works. In turn, TUKYSA may affect how these medicines work. These medicines include some of 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 a severe mood disorder when other medicines do not work
• buspirone: used to treat certain mental health problems
• sirolimus, tacrolimus: used to control the 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 rhinoconjunctivitis
• everolimus, ibrutinib: used to treat some cancers
• naloxegol: used to treat constipation

Pregnancy and breast-feeding

TUKYSA may harm your 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 might be pregnant or plan to become pregnant, tell your doctorbefore taking this medicine. Your doctor will weigh the potential benefits for you against the risks for the baby.
• Use a reliable method of contraceptionto prevent pregnancy while taking TUKYSA and for at least 1 week after the last dose.
• If you are a man and have a female partner who can become pregnant, use a reliable method of contraceptionto prevent pregnancy while taking TUKYSA and for at least 1 week after the last dose.
• If you become pregnantduring treatment with TUKYSA, tell your doctor. Your doctor will assess the potential benefits for you in continuing with the medicine and the risks for the baby.

It is not known if TUKYSA passes into breast milk.

• If you are breast-feedingor plan to breast-feed, tell your doctorbefore taking this medicine. You should not breast-feed during treatment with TUKYSA and for at least 1 week after the last dose. Ask your doctor for advice on the best way to feed your baby during treatment.

If you have any questions, ask your doctor or pharmacistbefore taking TUKYSA.

Driving and using machines

TUKYSA is not expected to affect your ability to drive or use machines. However, you are responsible for deciding whether you can drive a car or perform other tasks that require increased attention.

TUKYSA contains sodium and potassium

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

This medicine contains 60.6 mg of potassium per 300 mg dose, which should be taken into consideration in patients with renal impairment or in patients on a low potassium diet.

3. How to take TUKYSA

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Dosage

The recommended dose is 300 mg (two 150 mg tablets) taken orally twice a day.

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

Method of administration

TUKYSA can be taken with or without food.

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

If you take more TUKYSA than you should

Consult a doctor or pharmacist immediately. If possible, show them the pack.

If you forget to take TUKYSA

Do not take a double doseto make up for a forgotten dose. Simply take the next dose at the scheduled time.

If you stop taking TUKYSA

TUKYSA is a long-term treatment and you should take it continuously. Do not stop taking TUKYSAwithout talking to your doctor.

While taking TUKYSA

• Depending on the side effects you experience, your doctor may recommend a dose reduction or temporary interruption of treatment.
• Your doctor will also check your liver function during treatment with TUKYSA.

4. Possible side effects

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);
• vomiting;
• mouth sores, mouth inflammation, mouth ulcers;
• liver problems, which can cause itching, yellowing of the eyes and skin, dark urine, and pain or discomfort in the upper right stomach area;
• rash;
• joint pain;
• weight loss;
• nosebleeds.

Tell your doctor or pharmacistif you notice any of the side effects.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the Spanish Medicines Agency's website. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of TUKYSA

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

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What TUKYSA contains

The active substanceis tucatinib. Each film-coated tablet contains 50 mg or 150 mg of tucatinib.

The other ingredientsare:

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

Appearance of TUKYSA and pack contents

The TUKYSA 50 mg film-coated tablets (tablets) are round, yellow and engraved with “TUC” on one side and “50” on the other.

The TUKYSA 150 mg film-coated tablets (tablets) are oblong, yellow and engraved with “TUC” on one side and “150” on the other.

TUKYSA is supplied in aluminium blister packs. 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

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Brussels

Belgium

Manufacturer

Seagen B.V.

Evert van de Beekstraat 1-104

1118CL Schiphol

Netherlands

For further information on this medicine, contact the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

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