Patient leaflet - Tukysa 50 mg film coated tablets
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 it belongs to a group of medicines called protein kinase inhibitors which 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 which:
- 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 or cannot be removed by surgery
- has previously been treated with certain other breast cancer treatments
TUKYSA is taken with two other cancer medicines, trastuzumab and capecitabine. Separate patient information leaflets are available for these medicines. Ask your doctor to tell you about them.
How TUKYSA works
TUKYSA works by blocking the HER2 receptors on cancer cells. HER2 produces signals that can help the cancer to grow, and blocking it may slow or stop cancer cells from growing or may kill them altogether.
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
- Talk to your doctor before taking TUKYSA if you have liver problems. During your treatment, your doctor will run tests to check that your liver is working properly.
- TUKYSA can cause severe diarrhoea. Talk to your doctor right away at the first sign of diarrhoea (loose stool) and if your diarrhoea persists with nausea and/ or vomiting.
TUKYSA may cause harm to an unborn baby when taken by a pregnant woman. Talk to your doctor before you take TUKYSA if you think you may be pregnant or are planning to have a baby. See section on “Pregnancy and breast-feeding” below. Children and adolescents
TUKYSA should not be used in children under the age of 18 years. The safety of TUKYSA and how effective it is has 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 medicines. Some medicines may affect the way TUKYSA works or TUKYSA may affect the way they work. These medicines include some medicines in 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 serious mood disorder when other medicines do not work
- buspirone– used to treat certain mental health problems
- sirolimus, tacrolimus – used to control your 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 rhino-conjunctivitis
- everolimus, ibrutinib – used to treat certain cancers
- naloxegol – used to treat to treat constipation Pregnancy and breast-feeding
TUKYSA may cause harmful effects to an 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 may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. The doctor will weigh the potential benefit to you against the risk to the unborn baby.
- Use a reliable method of contraception to avoid becoming pregnant while you are taking TUKYSA and for at least 1 week after the last dose.
- If you are male and have a female sexual partner who can become pregnant, use a reliable method of contraception to avoid pregnancy while you are taking TUKYSA and for at least 1 week after the last dose.
- If you become pregnant during treatment with TUKYSA, tell your doctor. The doctor will assess the potential benefit to you of continuing this medicine and the risk to the unborn baby.
It is not known whether TUKYSA passes into breast milk.
- If you are breast-feeding or planning to breast-feed, ask your doctor for advice before taking this medicine. You should not breast-feed during treatment with TUKYSA and for at least 1 week after the last dose. Talk to your doctor about the best way to feed your baby during treatment.
Ask your doctor or pharmacist for advice before taking TUKYSA if you have any questions.
Driving and using 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 motor vehicle or perform other tasks that require increased concentration. TUKYSA contains sodium and potassium
This medicine contains 55.3 mg sodium (main component of cooking/table salt) in each 300 mg dose. This is equivalent to 2.75% of the recommended maximum daily dietary intake of sodium for an adult.
This medicine contains 60.6 mg potassium per 300 mg dose. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
3. How to take TUKYSA
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Dose
The recommended dose is 300 mg (two 150 mg tablets) by mouth twice a day.
Your doctor may change your dose of TUKYSA if you experience certain side effects. To allow for 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 after the other. Do not chew or crush the tablet to ensure the active ingredient is released as intended.
- Take each dose about 12 hours apart at the same times every day.
- Do not take an additional dose if you vomit after taking TUKYSA but continue with the next scheduled dose. While you are taking TUKYSA
- Depending on the side effects you have, your doctor may recommend lowering your dose or temporarily stopping your treatment.
- Your doctor will also check your liver function during treatment with TUKYSA.
If you take more TUKYSA than you should Talk to a doctor or pharmacist straight away. If possible, show them the pack.
If you forget to take TUKYSA
Do not take a double dose to make up for a forgotten dose. Just take the next dose at the scheduled time. If you stop taking TUKYSA
TUKYSA is for long-term treatment and you should take it continuously. Do not stop taking TUKYSA without talking to 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;
- feeling sick (nausea);
- being sick (vomiting);
- mouth sores, inflammation of the mouth, mouth ulcers;
- liver problems, which may cause itching, yellowing of eyes and skin, dark urine and pain or discomfort in the upper right area of the stomach;
- rash;
- joint pain;
- weight loss;
- nosebleed.
Tell your doctor or pharmacist if you notice any side effects.
Reporting of side effects
If you get 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 which is stated on the blister and the carton. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What TUKYSA contains
The active substance is tucatinib. Each film-coated tablet contains either 50 mg or 150 mg tucatinib.
The other ingredients are:
Tablet core: copovidone, crospovidone, sodium chloride, potassium chloride, sodium hydrogen carbonate, silica, colloidal anhydrous, magnesium stearate,
microcrystalline cellulose (see section 2 “TUKYSA contains sodium and potassium”).
- Film-coating: poly (vinyl alcohol), titanium dioxide, macrogol, talc, yellow iron oxide.
What TUKYSA looks like and contents of the pack TUKYSA 50 mg film-coated tablets are round, yellow and debossed with “TUC” on one side and “50” on the reverse side.
TUKYSA 150 mg film-coated tablets are oval shaped, yellow and debossed with “TUC” on one side and “150” on the reverse side.
TUKYSA is supplied in aluminium foil blisters. 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 Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
Manufacturer
Corden Pharma GmbH
Otto-Hahn-Strasse 1
Plankstadt
Baden-Wuerttemberg
68723
Germany
This leaflet was last revised in 08/2025.
Ref: TS 3_0
2025-1005328-1/1