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 more to look forward to. – Sharon, Living with HER2+ MBC”
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As demonstrated in the HER2CLIMB study

The TUKYSA Regimen* Offered Adults Living With HER2+ Metastatic Breast Cancer More Time

On this page, you can learn more about:

 

*TUKYSA is a part of a treatment plan that includes trastuzumab and capecitabine.
Depiction of how TUKYSA® (tucatinib) and trastuzumab work. TUKYSA® (tucatinib) targets HER2 from inside the cell. Trastuzumab targets HER2 from outside the cell. See safety info.

Target HER2 in 2 Ways

You may have taken trastuzumab before. But when TUKYSA is taken with trastuzumab, they work together to offer another chance to slow the progression of cancer and may help you live longer. 

Both TUKYSA and trastuzumab are designed to target HER2, but they do it in different ways. More than either therapy alone, TUKYSA and trastuzumab in combination may work together to more completely block the signal that tells cancer cells to grow. 

HER2 is also found on normal cells. This means HER2-targeted therapies can affect normal cells and cause side effects, some of which may be serious.

TUKYSA (tucatinib) Was Evaluated in a Clinical Study Called HER2CLIMB

Who was in the study

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  • Adults living with HER2+ breast cancer that could not be removed by surgery or had spread somewhere in the body such as their liver, lungs, bones, and/or brain
  • Adults with different types of brain metastases, including those that were growing when the person entered the study
  • Adults who had been previously treated with Herceptin® (trastuzumab), Perjeta® (pertuzumab), and Kadcyla® (ado-trastuzumab emtansine)

How many adults were in the study

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  • 612 adults were enrolled in the study, of whom the first 480 were assessed for the primary endpoint of progression-free survival
  • 48% (291 of the 612 adults) had brain metastases when they entered the study
  • Among the adults with brain metastases:
  • 40% had stable brain metastases, which means they were not growing or spreading
  • 60% had active brain metastases, which means they were growing or spreading

The treatment they received

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  • Adults were randomly assigned to a treatment group:
  • 410 adults received treatment with TUKYSA, along with trastuzumab and capecitabine
  • 202 adults received treatment with trastuzumab and capecitabine alone

The goal of the study

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  • The study wanted to see how long TUKYSA stopped cancer from growing or spreading
  • Results were reported in median months
  • Median: The middle number in a group of numbers arranged from lowest to highest

As demonstrated in the HER2CLIMB study

The TUKYSA Regimen* Has Been Proven to Offer More Time Without the Cancer Growing or Spreading

  • In the clinical study, 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

Median: The middle number in a group of numbers arranged from lowest to highest.

Over the course of the trial, the TUKYSA regimen* led to

46% Reduction in the chance of disease progression or death, compared to control arm. See safety info.

 

In the HER2CLIMB Study, the TUKYSA Regimen* Helped People Live Longer

Median overall survival data from the HER2CLIMB study. TUKYSA® (tucatinib) + trastuzumab + capecitabine demonstrated a 21.9 months median overall survival (review ‡) vs 17.4 months (review ‡) for Placebo +  trastuzumab + capecitabine. People lived, on average, 4.5 months longer when TUKYSA® (tucatinib) was included in their regimen. See safety info.

As a follow-up analysis, per protocol, a pre-specified analysis was performed 24 months after the last person was enrolled. Results depicted below from this follow-up analysis are exploratory. This means the study was not designed to find differences between the two groups at that time point. Please interpret with caution.

Median overall survival at follow-up (exploratory analysis). TUKYSA® (tucatinib) + trastuzumab + capecitabine (review ‡) demonstrated 24.7 months median overall survival at follow-up (exploratory analysis). Placebo + trastuzumab + capecitabine (review ‡) demonstrated 19.2 months median overall survival at follow-up (exploratory analysis).

 

Overall survival: A measure of how long people live once starting a clinical study.

 

*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.
Quote board that reads, “Time is hard to put into words, but I know I want more. – Debbie, Living with HER2+ MBC”Quote board that reads, “Time is hard to put into words, but I know I want more. – Debbie, Living with HER2+ MBC”

As demonstrated in the HER2CLIMB study

The TUKYSA Regimen* Offered More Time Without Cancer Growing or Spreading in People With Brain Metastases

  • In the clinical study, the median amount of time that cancer did not grow or spread in people living with brain metastases was 7.6 months with TUKYSA (tucatinib), along with trastuzumab and capecitabine, versus 5.4 months with trastuzumab and capecitabine alone

Median: The middle number in a group of numbers arranged from lowest to highest.

Over the course of the trial, the TUKYSA regimen* led to

52% reduction in the chance of disease progression or death for patients with brain metastases, compared to the control arm. See safety info.

*TUKYSA is a part of a treatment plan that includes trastuzumab and capecitabine.
Studied in 198 people with brain metastases who received TUKYSA, along with trastuzumab and capecitabine, and in 93 people with brain metastases who received trastuzumab and capecitabine alone.

Learn More About Treatment With TUKYSA in This Short Video

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.