Prospect: information for the patient

TUKYSA 50mg film-coated tablets

TUKYSA 150mg film-coated tablets

tucatinib

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section4 includes information on how to report these adverse effects.

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

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus. See section4.

What is TUKYSA

TUKYSA is a cancer medication for breast cancer. It contains the active ingredient tucatinib and belongs to a group of medications called protein kinase inhibitors that prevent the growth of some types of cancer cells in the body.

How is TUKYSA used

TUKYSA is used for adults with breast cancer that:

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

TUKYSA is taken with two other cancer medications, trastuzumab and capecitabina.There are separate prospectuses for patients on these medications.Ask your doctorto inform you about them.

How TUKYSA works

TUKYSA acts by blocking the HER2 receptors in cancer cells. HER2 produces signals that can help cancer grow, and by blocking it, the growth of cancer cells can be delayed or stopped, or they can be killed completely.

Do not take TUKYSA

• if you are allergic to tucatinib or any of the other ingredients in this medicine (listed in section6).

Warnings and precautions

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

• TUKYSA may cause severe diarrhea. Consult your doctor immediately if you experience the first signs of diarrhea (loose stools) and if diarrhea persists with nausea and/or vomiting.

• TUKYSA may cause harm to the fetus when taken by a pregnant woman. Consult your doctor before starting TUKYSA if you think you may be pregnant or intend to become pregnant. See the section on “Pregnancy and breastfeeding” below.

Children and adolescents

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

Other medicines and TUKYSA

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

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 facial condition called trigeminal neuralgia or to control a severe mood disorder when other medicines do not work
• buspirone: used to treat certain mental health problems
• sirulimus, tacrolimus: used to control the immune response of your body 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 cause harm to the fetus when taken by a pregnant woman.Your doctor will do a pregnancy test before you start taking TUKYSA.

• If you arepregnant,think you may be pregnant, or intend to become pregnant, consult your doctorbefore using this medicine. Your doctor will weigh the potential benefits for you against the risks to the fetus.
• Use a reliable method of contraceptionto avoid pregnancy while taking TUKYSA and for at least 1week after the last dose.
• Use a reliable method of contraceptionto avoid pregnancy if you are a man and have a female sexual partner who may become pregnant, while taking TUKYSA and for at least 1week after the last dose.
• If you becomepregnantduring treatment with TUKYSA, inform your doctor.Your doctor will evaluate the potential benefits for you by continuing the medicine and the risks to the fetus.

It is unknown whether TUKYSA is excreted in breast milk.

• If you arebreastfeedingor intend tobreastfeed,consult your doctorbefore using this medicine. Do not breastfeed during treatment with TUKYSA and for at least 1week after the last dose. Consult your doctor on the best way to feed your baby during treatment.

If you have any doubts,consult your doctor or pharmacistbefore taking TUKYSA.

Driving and operating 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 car or perform other tasks that require greater concentration.

TUKYSA contains sodium and potassium

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

This medicine contains 60.6mg of potassium per 300mg dose, which should be taken into account in patients with renal insufficiency or in patients on low-potassium diets.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage

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

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

Administration Form

TUKYSA can be taken with food or between meals.

•Swallow the tablets whole, one after the other.

•Take each dose with an interval of about 12hours, at the same hours every day.

•Do not chew or crush the tablet.

•Do not take an additional 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 packaging.

If you forget to take TUKYSA

Do not take a double dosetomake up for the missed doses. Simply take the next dose at the scheduled time.

If you interrupt treatment with TUKYSA

TUKYSA is a long-term treatment and you should continue taking it.Do not stop TUKYSAwithout consulting your doctor.

While taking TUKYSA

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them. With this medication, the following side effects may appear.

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

• diarrhea;
• desire to vomit (nausea);
• vomiting;
• mouth sores, inflammation of the mouth, mouth ulcers;
• liver problems, which may cause itching, yellow discoloration of the eyes and skin, dark-colored urine, and pain or discomfort in the upper right side of the stomach;
• hives;
• joint pain;
• weight loss;
• nasal bleeding.

Inform your doctor or pharmacistif you observe any adverse effect.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and the box. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of TUKYSA

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

The other components are:

• Core tablet: copovidone, crospovidone, sodium chloride, potassium chloride, sodium hydrogen carbonate, anhydrous colloidal silica, magnesium stearate, microcrystalline cellulose (see section2 “TUKYSA contains sodium and potassium”).
• Film coating: polyvinyl alcohol, titanium dioxide, macrogol, talc, yellow iron oxide.

Appearance of TUKYSA and contents of the pack

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

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

TUKYSA is supplied in aluminium foil blisters. Each pack contains:

TUKYSA 50mg film-coated tablets

TUKYSA 150mg film-coated tablets

Only some pack sizes may be marketed.

Marketing authorisation holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Manufacturer responsible

Seagen B.V.

Evert van de Beekstraat 1-104

1118CL Schiphol

Netherlands

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of the summary of product characteristics:

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.