Important Safety Information

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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.

Sharon, who lives with HER2+ MBC, holding a quote board that reads, “More time means everything to me. – Sharon, living with HER2+ MBC”

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.

Learn more about TUKYSA
*Previously treated with trastuzumab, pertuzumab, and trastuzumab emtansine.
TUKYSA is part of a treatment plan that includes trastuzumab and capecitabine.
Studied in 320 people who received TUKYSA, along with trastuzumab and capecitabine, and in 160 people who received trastuzumab and capecitabine alone.
§Studied in 410 people who received TUKYSA, along with trastuzumab and capecitabine, and in 202 people who received trastuzumab and capecitabine alone.

 

Sharon, who lives with HER2+ MBC, holding a quote board that reads, “It’s OK to be down, but I don’t stay down. – Sharon, living with HER2+ MBC”
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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
These are not all the possible side effects of TUKYSA (tucatinib), and you may also get side effects from the other medicines taken with TUKYSA.

Here’s what you can expect from treatment

Side effects
Debbie, who lives with HER2+ MBC, sitting next to a quote board that reads, “I have cancer everyday, but I don’t let it take over my day. – Debbie, Living with HER2+ MBC”
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Another Chance at Treating Your Cancer

TUKYSA is a targeted oral treatment option taken with Herceptin® (trastuzumab) and Xeloda® (capecitabine). It's for people with HER2+ metastatic breast cancer who have received one or more anti-HER2 breast cancer treatments, such as trastuzumab, Perjeta® (pertuzumab), or Kadcyla® (ado-trastuzumab emtansine), in the metastatic setting.

Learn how treatment with TUKYSA may help

Find out more
Debbie, who lives with HER2+ MBC, holding a quote board that reads, “My family is that extra something that keeps me going. – Debbie, Living with HER2+ MBC”
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Ready to Learn More About TUKYSA?

Get answers to frequently asked questions about treatment

TUKYSA FAQs
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Our 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

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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.

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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

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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.