Tukysa 150 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

TUKYSA 50 mg film-coated tablets

TUKYSA 150 mg film-coated tablets

tucatinib

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What TUKYSA is and what it is used for

What TUKYSA is

TUKYSA is a medicine for breast cancer. It contains the active substance tucatinib and belongs to a group of medicines called tyrosine kinase inhibitors that block the growth of certain types of cancer cells in the body.

What TUKYSA is used for

TUKYSA is used in adults who have breast cancer that:

• has a receptor (target) on the cancer cells called 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 breast cancer treatments

TUKYSA is taken in combination with two other anticancer medicines, trastuzumab and capecitabine. Separate patient leaflets are available for these medicines. Ask your doctor for information about them.

How TUKYSA works

TUKYSA works by blocking HER2 receptors on cancer cells. HER2 sends signals that can help cancer grow, and by blocking it, TUKYSA can slow down or stop the growth of cancer cells or may even kill them completely.

2. What you need to know before taking TUKYSA

Do not take TUKYSA

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

Warnings and precautions

• Talk to your doctor before starting TUKYSA if you have liver problems. During treatment, your doctor will perform tests to monitor your liver function.

• TUKYSA can cause severe diarrhea. Contact your doctor immediately at the first sign of diarrhea (loose stools) and if diarrhea persists with nausea and/or vomiting.

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

Children and adolescents

TUKYSA must not be used in children under 18 years of age. The safety and effectiveness of TUKYSA have 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 need to take any other medicines.

Some medicines can affect how TUKYSA works. Likewise, TUKYSA can affect how other medicines work. These include some of the following:

• 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, trigeminal neuralgia (a painful facial condition), or to control a severe mood disorder when other medicines are ineffective
• buspirone: used to treat certain mental health conditions
• sirolimus, tacrolimus: used to control your body’s immune response after transplantation
• 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 certain cancers
• naloxegol: used to treat constipation

Pregnancy and breastfeeding

TUKYSA may harm the fetus when taken by a pregnant woman. Your doctor will perform a pregnancy test before you start taking TUKYSA.

• If you are pregnant, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Your doctor will weigh the potential benefits for you against the risks to the fetus.
• Use a reliable method of contraception to prevent pregnancy while taking TUKYSA and for at least 1 week after the last dose.
• If you are a male with a female partner who could become pregnant, use a reliable method of contraception to prevent pregnancy while taking TUKYSA and for at least 1 week after the last dose.
• If you become pregnant during treatment with TUKYSA, inform your doctor. Your doctor will evaluate the potential benefits of continuing the treatment for you and the risks to the fetus.

It is unknown whether TUKYSA is excreted in human breast milk.

• If you are breastfeeding or plan to breastfeed, consult your doctor before using this medicine. You must not breastfeed during treatment with TUKYSA and for at least 1 week after the last dose. Discuss with your doctor the best way to feed your baby during treatment.

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

Driving and use of machines

TUKYSA is not expected to affect your ability to drive or operate machinery. However, you are responsible for deciding whether you are fit to drive a car or perform tasks requiring concentration.

TUKYSA contains sodium and potassium

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

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

3. How to take TUKYSA

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Dosage

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

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

Method of administration

TUKYSA may be taken with food or between meals.

• Swallow the tablets whole, one after the other. Do not chew or crush the tablet, as this may alter the release pattern of the active substance.
• Take each dose approximately 12 hours apart, at the same times every day.
• If you vomit after taking TUKYSA, do not take an additional dose; continue with the next scheduled dose.

While taking TUKYSA

• Depending on any adverse effects you may experience, your doctor may recommend reducing the dose or temporarily stopping treatment.
• Your doctor will also monitor liver function during treatment with TUKYSA.

If you take more TUKYSA than you should

Contact a doctor or pharmacist immediately. If possible, show them the packaging.

If you forget to take TUKYSA

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

If you stop taking TUKYSA

TUKYSA is a long-term treatment and should be taken continuously. Do not stop TUKYSA without consulting your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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 ulcers, mouth inflammation, mouth sores;
• liver problems, which may cause itching, yellowing of the eyes and skin, dark-coloured urine, and pain or discomfort in the upper right side of the stomach;
• rash;
• joint pain;
• weight loss;
• nosebleeds.

Tell your doctor or pharmacist if you notice any adverse effect.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the blister and on the carton. The expiry date is the last day of the month indicated.

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 and packaging that you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of TUKYSA

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

The other components 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 contents of the container

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

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 aluminum foil blisters. Each pack contains:

TUKYSA 50 mg film-coated tablets

• 88 tablets (11 blisters containing 8 tablets each).

TUKYSA 150 mg film-coated tablets

• 84 tablets (21 blisters containing 4 tablets each).

Only certain 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
The Netherlands

or

Corden Pharma GmbH
Otto-Hahn-Strasse 1
Plankstadt Baden-Wuerttemberg
68723
Germany

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

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