50 mg Film-coated tablet
Tukatinib
What Tukysa is and what it is used for
TUKYSA is a medicine against breast cancer. It contains the active substance tukatinib and it belongs to the drug group tyrosine 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:
- which has a receptor (target) on the cancer cells called human epidermal growth factor receptor 2 ( HER2 -positive breast cancer)
- where thecer has spread beyond the original tumor or to other organs such as the brain, or which cannot be removed with surgery .
- ho have previously been treated with certain other breast cancer treatments
TU?KYSA is taken together with two other cancer medicines, trastuzumab an,d capecitabine . eparate 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. Signals from HER2 can help the cancer grow, and blocking HER2 can therefore slow or stop the growth of cancer cells or destroy them altogether.
What you need to know before using Tukysa
Do not use Tukysa
Do not take TUKYSA
- if you are allergic to tukatinib 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 treatment, the doctor takes samples to check that your liver is working as it should.
- TUSA can cause severe diarrhea. Talk to your doctor immediately at the first sign of diarrhea.
- TUKYSA can cause birth defects if taken by a pregnant woman. Tell your doctor if you are taking, have recently taken or might take any other medicines. See the section on “Pregnancy and breast-feeding below”.
Children and young people
TUKYSA should not be used in children under 18 years of age. The safety of TUKYSA and its effectiveness 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 medicines.
Certain medicines can affect how TUKYSA works or TURKYSA can affect how they work. These medicines include certain medicines in the following groups:
- St. John’s wort – a plant-based medicine used as a treatment for mild depression and mild anxiety
- 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 don’t work
- buspirone — used for certain types of mental disorders
- sirolimus, tacrolimus – used to control the body’s immune response after a transplant
- digoxin – used as a treatment for heart problems
- lomitapide, lovastatin – used to treat high cholesterol levels
- alfentanil – used to relieve pain
- avanafil, vardenafil – used as a treatment for erectile dysfunction
- darifenacin – used to treat urinary incontinence
- midazolam, triazolam – used to treat seizures, anxiety disorders, panic, restlessness 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 types of cancer
- naloxegol – used to treat constipation
Pregnancy, breastfeeding and fertility
TUKYSA may cause harmful effects to the unborn baby if taken by a pregnant woman. You may give a pregnancy test to the doctor before you start taking TUKYSA.
- If you are pregnant, think you may be pregnant or are planning to have a baby , consult your doctor before using this medicine. The doctor will weigh the potential benefit to you against the risk to the unborn baby.
- Use reliable birth control to avoid becoming pregnant while taking TUKYSA for at least 1 week after stopping treatment.
- If you are male and have a female fertile sexual partner, use reliable birth control to avoid pregnancy while taking TUKYSA for at least 1 week after stopping treatment.
- If you become pregnant during treatment with TUKYSA, tell your doctor . The doctor will assess the potential benefit to you of continuing to take this medicine and the risk to the unborn baby.
It is unknown if TUKYSA is excreted in breast milk.
- If you are breastfeeding or plan to breastfeed , consult your doctor before using this medicine. You should not breastfeed during treatment with TUKYSA and for at least 1 week after the last dose . Talk to the doctor about the best way to feed your baby during treatment.
Ask your doctor or pharmacist before taking TUKYSA if you have any questions.
Driving ability and use of machinery
TUKYSA is not expected to affect the ability to drive or use machines. You yourself are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention.
Tukysa contains excipients
TUKYSA contains sodium and potassium
This medicine contains 55.3 mg of sodium (the main ingredient in common/table salt) per 300 mg dose .
This corresponds to 2.75% of the maximum recommended daily intake of sodium for adults.
This medicine contains 60.6 mg of potassium per 300 mg dose . This should be taken into account by patients with reduced renal function or patients prescribed a potassium-poor diet.
How to use Tukysa
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Dosage
The recommended dose is 300 mg (two 150 mg tablets) twice a day. The tablets should be swallowed.
The doctor can change the dose of TUKYSA if you get certain side effects . To allow for a lower dose , the doctor may prescribe 50 mg tablets.
Mode of administration
TUKYSA can be taken with food or between meals.
- Swallow the tablets whole, one by one.
- Take each dose approximately 12 hours apart, at the same time each day.
- The tablet should not be chewed or crushed.
- Do not take an additional dose if you vomit after taking TUKYSA, but take the next scheduled dose as usual.
If you have used too much Tukysa
Talk to your doctor or pharmacist immediately. If possible, show them the packaging.
If you forget to use Tukysa
Do not take a double dose to make up for a missed dose . Just take the next dose at the regular dosing time.
If you stop using Tukysa
TUKYSA is a long-term treatment and you must take it continuously. Do not stop taking TUKYSA without talking to your doctor.
While taking TUKYSA
- Depending on which side effects you get, the doctor may recommend a dose reduction or a temporary treatment break.
- The doctor will also check your liver function during treatment with TUKYSA.
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 users)
- diarrhea
- nausea
- vomiting
- mouth ulcers, inflammation of the mouth, mouth ulcers
- liver problems, which can cause itching , a yellowing of the eyes and skin, dark urine and pain or discomfort in the upper abdomen
- rash
- joint pain
- weight loss
- nosebleed.
If you get side effects , talk to your doctor or pharmacist.
How Tukysa should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the blister and carton. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is tukatinib. Each film-coated tablet contains either 50 mg or 150 mg of tukatinib.
Other ingredients are:
- Tablet core – copovidone, crospovidone, sodium chloride, potassium chloride, sodium bicarbonate, colloidal , anhydrous silicon dioxide, magnesium stearate, microcrystalline cellulose (see section 2 “TUKYSA contains sodium and potassium”).
- Film coating – poly(vinyl alcohol), titanium dioxide, macrogol, talc, yellow iron oxide.
Appearance and package sizes of the medicine
TUKYSA 50 mg film-coated tablets are round, yellow and debossed with “TUC” on one side and “50” on the other side.
TUKYSA 150 mg film-coated tablets are oval, yellow and debossed with “TUC” on one side and “150” on the other side.
TUKYSA is supplied in aluminum foil blisters. Each pack contains:
TUKYSA 50 mg film-coated tablets
- 88 tablets (11 blisters with 8 tablets in each blister).
TUKYSA 150 mg film-coated tablets
- 84 tablets (21 blisters with 4 tablets in each blister).
Not all pack sizes may be marketed.
Seagen BV
Evert van de Beekstraat 1-104
1118CL Schiphol
Netherlands
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
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