Indication: 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.

TUKYSA™ (tucatinib) tablets
TUKYSA™ (tucatinib) tablets
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TUKYSA is a New Option for People Living with HER2+ Metastatic Breast Cancer

HER2+ metastatic breast cancer (MBC): A type of breast cancer where there is more HER2 on the surface of the cancer cells than on healthy breast cells.

Along with HERCEPTIN® (trastuzumab) and XELODA® (capecitabine),

TUKYSA was Evaluated in a Clinical Study Called HER2CLIMB

Who was in the study
How many people were in the study
The treatment they received
The goal of the study
  • Everyone had HER2+ breast cancer that had spread somewhere in their bodies such as their liver, lungs, bones, and/or brain
  • People had been previously treated with trastuzumab, PERJETA® (pertuzumab), and KADCYLA® (trastuzumab emtansine)
  • 480 people started the study and more were added (total 612) to help investigators better detect the benefits of TUKYSA and understand the side effects
  • People were randomly assigned to a treatment group:
  • 410 people received treatment with TUKYSA*
  • 202 people received treatment with trastuzumab and capecitabine alone
  • The study wanted to see how long TUKYSA* stopped cancer from growing and spreading
  • Results were reported in median months

HER2CLIMB was Inclusive

Nearly half of the people in the study--48% (291 out of 612 people)--had brain metastases

HER2CLIMB was Inclusive

Nearly half of the people in the study--48%(291 out of 612 people)--had brain metastases
Median: The middle number in a group of numbers that are listed from lowest to highest; also called the midpoint.
* TUKYSA is part of a treatment plan that includes trastuzumab and capecitabine.

TUKYSA* Offered More Time

More time without the cancer growing and spreading

  • In the clinical study, the median amount of time without cancer progressing was 7.8 months with TUKYSA, along with trastuzumab and capecitabine, versus 5.6 months with trastuzumab and capecitabine alone

More than 2.5 times as many people had not progressed at 12 months

treated with TUKYSA, along with trastuzumab and capecitabine

VS

treated with trastuzumab and capecitabine

  • The results at 12 months are from an exploratory analysis. This means that the study was not designed to find differences between the two groups at that time.

TUKYSA* helped people live longer

  • In the clinical study, the median overall survival was 21.9 months with TUKYSA, along with trastuzumab and capecitabine, versus 17.4 months with trastuzumab and capecitabine alone
Median: The middle number in a group of numbers that are listed from lowest to highest; also called the midpoint.
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.

Select 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 fluid (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.

Select 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 fluid (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.

Stopped Cancer From Growing and Spreading

  • In the clinical study, the median amount of time that cancer had not progressed in people with brain metastases was 7.6 months with TUKYSA, along with trastuzumab and capecitabine, versus 5.4 months with trastuzumab and capecitabine alone

More people with brain metastases had not progressed at 12 months

treated with TUKYSA, along with trastuzumab and capecitabine

VS

treated with trastuzumab and capecitabine

  • The results at 12 months are from an exploratory analysis. This means that the study was not designed to find differences between the two groups at that time.
Median: The middle number in a group of numbers that are listed from lowest to highest; also called the midpoint.
More People Responded to Treatment With TUKYSA*

Almost twice as many people in the clinical study saw their tumors shrink

treated with TUKYSA, along with trastuzumab and capecitabine

VS

treated with trastuzumab and capecitabine

*TUKYSA is part of a treatment plan that includes trastuzumab and capecitabine.

39.7% (135 out of 340) of people saw their tumors shrink with TUKYSA* vs 21.6% (37 out of 171) of people treated with trastuzumab and capecitabine alone; 0.9% (3 of 340) of people had their tumors completely disappear with TUKYSA* vs 1.2% (2 of 171) of people treated with trastuzumab and capecitabine alone.

Select Safety Information

The most common side effects of TUKYSA:
  • diarrhea
  • rash, redness, pain, swelling, or blisters on the palms of your hands or soles of your feet
  • nausea
  • tiredness
  • increased liver function blood tests
  • vomiting
  • mouth sores (stomatitis)
  • decreased appetite
  • stomach-area (abdomen) pain
  • headache
  • 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 are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/Safety/MedWatch or call 1-800-FDA-1088.

Select Safety Information

The most common side effects of TUKYSA:
  • diarrhea
  • rash, redness, pain, swelling, or blisters on the palms of your hands or soles of your feet
  • nausea
  • tiredness
  • increased liver function blood tests
  • vomiting
  • mouth sores (stomatitis)
  • decreased appetite
  • stomach-area (abdomen) pain
  • headache
  • 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 are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/Safety/MedWatch or call 1-800-FDA-1088.

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 fluid (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.
The most common side effects of TUKYSA:
  • diarrhea
  • rash, redness, pain, swelling, or blisters on the palms of your hands or soles of your feet
  • nausea
  • tiredness
  • increased liver function blood tests
  • vomiting
  • mouth sores (stomatitis)
  • decreased appetite
  • stomach-area (abdomen) pain
  • headache
  • 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 are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/Safety/MedWatch or call 1-800-FDA-1088.

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 get pregnant. TUKYSA can harm your unborn baby.

    Females who are able to 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 at least 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 at least 1 week after the last dose of TUKYSA.

  • are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed during treatment with TUKYSA and for at least 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.

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.