TUKYSA 50 mg FILM-COATED TABLETS

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 can cause severe diarrhea. Tell your doctor immediately if you have the first sign of diarrhea (loose stools) and if diarrhea persists with nausea and/or vomiting.

• TUKYSA can harm the fetus 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 breastfeeding” 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 breastfeeding

TUKYSA may harm the fetus 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 and the risks for the fetus.
• 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 male 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 to continue with the medicine and the risks for the fetus.

It is not known if TUKYSA is excreted in breast milk.

• If you are breastfeedingor plan to breastfeed, tell your doctorbefore taking this medicine. Do not breastfeed during treatment with TUKYSA and for at least 1 week after the last dose. Ask your doctor for 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 with low potassium diets.

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) orally twice a day.

Your doctor may change the 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 an interval 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 forgotten doses. 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 consulting your doctor.

While taking TUKYSA

• Depending on the side effects you have, your doctor may recommend reducing the dose or temporarily stopping 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):

• diarrhea;
• 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 side effects.

Reporting of side effects

If you experience 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 the Yellow Card Scheme: www.mhra.gov.uk/yellowcard. 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 shown.

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 ingredients are:

• 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 are round, yellow, and engraved with “TUC” on one side and “50” on the other.

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

TUKYSA is supplied in aluminum 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 authorization 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 about this medicine, contact the local representative of the marketing authorization holder:

Date of last revision of this leaflet:

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