Tukysa

Package leaflet: Information for the patient

TUKYSA 50 mg film-coated tablets, 150 mg film-coated tablets

tucatinib
Please read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this 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 protein kinase inhibitors, which prevent the
growth of certain types of cancer cells in the body.
What TUKYSA is used for
TUKYSA is used in adults with 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 tumour or to other organs such as the brain and cannot be removed by surgery
• has been previously treated with certain other breast cancer therapies.

TUKYSA is taken together with two other anticancer medicines called trastuzumab and capecitabine.
Separate patient information leaflets are available for these medicines. Ask your doctor for
further information.
How TUKYSA works
TUKYSA works by blocking HER2 receptors on cancer cells. HER2 sends signals that
can promote tumour growth, so blocking it may slow down or stop the growth of
cancer cells or kill them.

2. What you should 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 taking TUKYSA if you have liver problems. During treatment, your doctor will perform tests to check that your liver is functioning properly.
• TUKYSA may cause severe diarrhea. Contact your doctor immediately at the first sign of diarrhea (loose stools), and if diarrhea persists along with nausea and/or vomiting.
• TUKYSA may harm the fetus when taken by a pregnant woman. Talk to your doctor before taking TUKYSA if you suspect you are pregnant or are planning a pregnancy. 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 efficacy 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 take any other
medicine.
Some medicines may affect how TUKYSA works, or TUKYSA may affect how other medicines work. Included are certain medicines from 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 severe mood disorders when other medicines do not work
• buspirone – used to treat certain mental health conditions
• sirolimus, tacrolimus – used to control the body’s immune response after transplantation
• digoxin – used to treat heart problems
• lomitapide, lovastatin – used to treat abnormal cholesterol levels
• alfentanil – used to relieve pain
• 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 have harmful effects on the fetus when taken by a pregnant woman. Your doctor will
perform a pregnancy test before you start taking TUKYSA.

• If you are pregnant, suspect you are pregnant, or are planning a pregnancy, consult your doctor before taking this medicine. Your doctor will assess the potential benefit to you against the risk to the fetus.
• Use an effective method of contraception to prevent pregnancy while taking TUKYSA and for at least 1 week after the last dose.
• If you are a man and have a female sexual partner who could become pregnant, use an effective 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 assess the potential benefit of continuing treatment for you against the risk to the fetus.

It is not known whether TUKYSA passes into breast milk.

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

If you have any doubts, ask your doctor or pharmacist before taking TUKYSA.
Driving and using machines
TUKYSA is not expected to affect the ability to drive vehicles or operate machinery. However,
it is your responsibility to decide whether you are fit to drive a motor vehicle or perform other tasks requiring
high concentration.
TUKYSA contains sodium and potassium
This medicine contains 55.3 mg of sodium (a main component of table salt) per 300 mg dose. This is equivalent to 2.75% of the maximum daily recommended dietary intake for an adult.
This medicine contains 60.6 mg of potassium per 300 mg dose. This should be taken into account in
patients with impaired renal function or in patients on a low-potassium diet.

3. How to take TUKYSA

Take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
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 you to take 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 at a time. Do not chew or crush the tablet, to ensure that the active substance is released as intended.
• Take doses approximately 12 hours apart, at the same time each day.
• Do not take an additional dose if you vomit after taking TUKYSA; continue with the next scheduled dose.

During treatment with TUKYSA

• Depending on the adverse effects you experience, your doctor may recommend reducing the dose or temporarily interrupting 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 the missed dose. Simply take the
next dose at the scheduled time.
If you stop taking TUKYSA
TUKYSA is a long-term treatment and must be taken continuously. Do not
stop treatment with TUKYSA without consulting your doctor.

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

Tell your doctor or pharmacist if you notice any side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 carton. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What TUKYSA contains
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, anhydrous colloidal silica, magnesium stearate, microcrystalline cellulose (see section 2 “TUKYSA contains sodium and potassium”)
• film coating: poly(vinyl alcohol), titanium dioxide, macrogol, talc, yellow iron oxide.

Description of the appearance of TUKYSA and contents of the pack
The film-coated tablets (tablets) of TUKYSA 50 mg are round, yellow in colour, and have “TUC” printed on one side and “50” on the other.
The film-coated tablets (tablets) of TUKYSA 150 mg are oval-shaped, yellow in colour, and have “TUC” printed on one side and “150” on the other.
TUKYSA is supplied in aluminium 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).

It is possible that not all pack sizes are 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
The Netherlands
or
Corden Pharma GmbH
Otto-Hahn-Strasse 1
Plankstadt
Baden-Wuerttemberg
Germany
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Latvija
Luxembourg/Luxemburg Pfizer Luxembourg SARL filiāle Latvijā
Pfizer NV/SA Tel: +371 670 35 775
Tél/Tel: +32 (0)2 554 62 11
България Lietuva
Pfizer Luxembourg SARL, Klone Bălgarija Pfizer Luxembourg SARL filialas Lietuvoje
Tel: +359 2 970 4333 Tel: +370 5 251 4000
Magyarország
Česká republika
Pfizer Kft.
Pfizer, spol. s r.o.
Tel.: +36 1 488 37 00
Tel: +420 283 004 111
Danmark Malta
Pfizer ApS Genesis Pharma (Cyprus) Ltd (Ċipru/Cyprus)
Tlf: +45 44 20 11 00 Tel: +357 22 765715
Deutschland Nederland
PFIZER PHARMA GmbH Pfizer bv
Tel: +49 (0)30 550055-51000 Tel: +31 (0)800 63 34 636
Eesti Norge
Pfizer Luxembourg SARL Eesti filiaal Pfizer AS
Tel: +372 666 7500 Tlf: +47 67 52 61 00
Ελλάδα Österreich
Pfizer Ελλάς A.E. Pfizer Corporation Austria Ges.m.b.H.
Τηλ: +30 210 6785800 Tel: +43 (0)1 521 15-0
ΓΕΝΕΣΙΣ ΦΑΡΜΑ Α.Ε.
Τηλ: +30 210 87 71 500
España Polska
Pfizer, S.L. Pfizer Polska Sp. z o.o.
Tel: +34 91 490 99 00 Tel.: +48 22 335 61 00
France Portugal
Pfizer Laboratoires Pfizer, Lda.
Tél: +33 (0)1 58 07 34 40 Tel: +351 21 423 5500
Hrvatska România
Pfizer Croatia d.o.o. Pfizer Romania S.R.L.
Tel: +385 1 3908 777 Tel: +40 (0) 21 207 28 00
Ireland Slovenija
Pfizer Healthcare Ireland Unlimited Company Pfizer Luxembourg SARL
Tel: 1800 633 363 (toll free) Pfizer, podružnica za svetovanje s področja
+44 (0)1304 616161 farmacevtske dejavnosti, Ljubljana
Tel: +386 (0)1 52 11 400
Ísland Slovenská republika
Icepharma hf. Pfizer Luxembourg SARL, organizačná zložka
Sími: +354 540 8000 Tel: +421 2 3355 5500
Italia Suomi/Finland
Pfizer S.r.l. Pfizer Oy
Tel: +39 06 33 18 21 Puh/Tel: +358 (0)9 430 040
Κύπρος Sverige
Genesis Pharma (Cyprus) Ltd Pfizer AB
Τηλ: +357 22 765715 Tel: +46 (0)8 550 520 00
More detailed information on this medicinal product is available on the website of the European Medicines Agency, https://www.ema.europa.eu.