Important Safety Information
What are the possible side effects of TUKYSA?
TUKYSA may cause serious side effects, including:
- Diarrhea (watery, loose, or frequent stools) is common and can sometimes be severe. Tell your healthcare provider if you have a change in your bowel movements or severe diarrhea. Severe diarrhea can cause a loss of too much body fluids (dehydration), low blood pressure, kidney problems, and death. Your healthcare provider may prescribe medicines to treat your diarrhea during treatment with TUKYSA.
- Liver Problems, including severe cases. Your healthcare provider will test your blood to check your liver function before starting and every 3 weeks during treatment with TUKYSA, or as needed. Tell your healthcare provider right away if you have any signs and symptoms of liver problems including itching, yellowing of the skin or eyes, dark or brown urine (tea-colored), pain or discomfort in the right upper stomach area (abdomen), feeling very tired, decreased appetite, or bleeding or bruising more easily than normal.
What is TUKYSA? TUKYSA is a prescription medicine used with the medicines trastuzumab and capecitabine to treat adults with human epidermal growth factor receptor-2 (HER2) positive breast cancer that has spread to other parts of the body such as the brain (metastatic), or that cannot be removed by surgery, and who have received one or more anti-HER2 breast cancer treatments. It is not known if TUKYSA is safe and effective in children.
With TUKYSA, More Time May Be Possible
TUKYSA/too-KYE-sah/ (tucatinib), along with Herceptin® (trastuzumab) and Xeloda® (capecitabine), offers another chance at treating HER2 positive (HER2+) metastatic breast cancer (MBC).
In a clinical study called HER2CLIMB that included adults with HER2+ breast cancer that could not be removed by surgery or had spread somewhere in the body such as the liver, lungs, bones, and/or brain and had been previously treated,* the TUKYSA regimen†:
- Offered more time without the cancer growing or spreading (the median amount of time people lived without cancer progressing was 7.8 months with TUKYSA, along with trastuzumab and capecitabine, versus 5.6 months with trastuzumab and capecitabine alone)‡
- Helped people live longer (the median overall survival was 21.9 months with TUKYSA, along with trastuzumab and capecitabine, vs 17.4 months with trastuzumab and capecitabine alone)§
HER2+ metastatic breast cancer: A type of breast cancer where there is more HER2 on the surface of the cancer cells than on healthy breast cells, and the cancer has spread to other parts of the body.
Median: The middle number in a group of numbers arranged from lowest to highest.
Possible Side Effects
The most common side effects of TUKYSA in combination with trastuzumab and capecitabine were:
- Diarrhea
- Rash, redness, pain, swelling, or blisters on the palms of your hands or soles of your feet
- Nausea
- Increased liver function blood tests
- Vomiting
- Mouth sores (stomatitis)
- Decreased appetite
- A low number of red blood cells (anemia)
- Rash
Here’s what you can expect from treatment
Side effectsAnother Chance at Treating Your Cancer
Learn how treatment with TUKYSA may help
Find out moreReady to Learn More About TUKYSA?
Get answers to frequently asked questions about treatment
TUKYSA FAQsOur Thanks and Gratitude
Pfizer would like to extend our sincere gratitude and deepest appreciation to the people living with HER2+ metastatic breast cancer and their families for:
- Participating in the clinical studies that enabled TUKYSA to be approved by the US Food and Drug Administration (FDA)
- Speaking about their experience and sharing their everyday hopes
Share Your Experience With TUKYSA
Your story can help educate, encourage, and inspire others.
Important Safety Information
What are the possible side effects of TUKYSA?
TUKYSA may cause serious side effects, including:
- Diarrhea (watery, loose, or frequent stools) is common and can sometimes be severe. Tell your healthcare provider if you have a change in your bowel movements or severe diarrhea. Severe diarrhea can cause a loss of too much body fluids (dehydration), low blood pressure, kidney problems, and death. Your healthcare provider may prescribe medicines to treat your diarrhea during treatment with TUKYSA.
- Liver Problems, including severe cases. Your healthcare provider will test your blood to check your liver function before starting and every 3 weeks during treatment with TUKYSA, or as needed. Tell your healthcare provider right away if you have any signs and symptoms of liver problems including itching, yellowing of your skin or eyes, dark or brown urine (tea-colored), pain in the right upper stomach area (abdomen), feeling very tired, decreased appetite, or bleeding or bruising more easily than normal.
The most common side effects of TUKYSA in combination with trastuzumab and capecitabine in adults with HER2-positive breast cancer include:
- diarrhea
- rash, redness, pain, swelling, or blisters on the palms of your hands or soles of your feet
- nausea
- increased liver function blood tests
- vomiting
- mouth sores (stomatitis)
- decreased appetite
- a low number of red blood cells (anemia)
- rash
Your healthcare provider may change your dose of TUKYSA, temporarily stop, or permanently stop treatment with TUKYSA if you have certain side effects.
TUKYSA may cause fertility problems in males and females, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility.
These are not all the possible side effects of TUKYSA. Discuss side effects with your healthcare provider. You may report negative side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/Safety/MedWatch.
What should I tell my healthcare provider before taking TUKYSA?
Before taking TUKYSA, tell your healthcare provider about all of your medical conditions, including if you:
- have liver problems.
- are pregnant or plan to become pregnant. TUKYSA can harm your unborn baby.
Females who can become pregnant: Your healthcare provider will do a pregnancy test before you start taking TUKYSA. Use effective birth control (contraception) during TUKYSA treatment and for 1 week after the last dose of TUKYSA. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with TUKYSA.
Males with a female partner who can get pregnant: Use effective birth control during TUKYSA treatment and for 1 week after the last dose of TUKYSA. - are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed during treatment with TUKYSA and for 1 week after the last dose of TUKYSA.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TUKYSA may affect the way your other medicines work, and other medicines may affect the way TUKYSA works. Keep a list of all the medicines you take and show it to your healthcare provider and pharmacist every time you get a new medicine.
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Indication
What is TUKYSA?
TUKYSA is a prescription medicine used with the medicines trastuzumab and capecitabine to treat adults with human epidermal growth factor receptor-2 (HER2) positive breast cancer that has spread to other parts of the body such as the brain (metastatic), or that cannot be removed by surgery, and who have received one or more anti-HER2 breast cancer treatments.
It is not known if TUKYSA is safe and effective in children.
Please see Important Facts about TUKYSA.