Important Safety Information

Indication
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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.

Debbie, who lives with HER2+ MBC, typing at a keyboard near a quote board that reads, “Sometimes going to work is the distraction I need. – Debbie, Living with HER2+ MBC”
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What to Expect During TUKYSA Treatment

Here’s what you can expect with TUKYSA (tucatinib):

  • It’s part of a treatment plan that also includes Herceptin® (trastuzumab) and Xeloda® (capecitabine)
  • Side effects are possible

 

Here’s How TUKYSA Is Taken

TUKYSA (tucatinib) is part of a treatment plan that includes Herceptin® (trastuzumab) and Xeloda® (capecitabine). Take TUKYSA exactly as your healthcare provider tells you.
TUKYSA® (tucatinib) Dosing Calendar
  • Take each dose about 12 hours apart and at the same times every day
  • Take TUKYSA with or without food
  • Swallow tablets whole. Do not chew, crush, or split the tablets. Do not take TUKYSA tablets if they are broken, cracked, or damaged
  • If you vomit or miss a dose of TUKYSA, take your next dose at your regular time
  • Your healthcare provider may change your dose of TUKYSA if needed
  • Keep TUKYSA tablets in the bottle that they came in. This bottle contains a drying agent (called a desiccant) that protects the tablets from moisture
  • Write the month and date on the bottle when first opened. Properly dispose of any tablets that have not been taken after 3 months
Trastuzumab Dosing Calendar
  • Receive trastuzumab at your healthcare provider’s office or infusion center on Day 1 and again every 21 days
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Sample page from the TUKYSA® (tucatinib) tablets Treatment Tracker document

Start and Stay on Your Treatment Plan With the TUKYSA Treatment Tracker

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Sharon, who lives with HER2+ MBC, sitting next to a quote board that reads, “I may not be happy every day, but I am glad that I am able to bounce back. – Sharon, living with HER2+ MBC”
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Side Effects Are Possible

Nearly everyone in the TUKYSA (tucatinib) clinical study had some side effects, whether they were treated with TUKYSA, along with trastuzumab and capecitabine, or trastuzumab and capecitabine alone.

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Serious Side Effects

During treatment with TUKYSA, serious side effects may occur and should be treated by your healthcare provider as early as possible.

  • 26% of people treated with TUKYSA, along with trastuzumab and capecitabine, had serious side effects
  • The most common serious side effects were diarrhea, vomiting, nausea, abdominal pain, and seizure

Be sure to tell your healthcare provider about any side effects you have. They may be able to help you find ways to manage them. Your healthcare provider may change your dose of TUKYSA, temporarily stop, or permanently stop treatment with TUKYSA if you have certain side effects.

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Common Side Effects

The most common side effects of TUKYSA in combination with trastuzumab and capecitabine in adults with HER2+ metastatic breast cancer were:

Diarrhea icon
Diarrhea
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Rash, redness, pain, swelling, or blisters on the palms of your hands or soles of your feet
Nausea icon
Nausea
Liver function icon
Increased liver function blood tests
Vomiting icon
Vomiting
Mouth sores icon
Mouth sores (stomatitis)
Decreased appetite icon
Decreased appetite
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A low number of red blood cells (anemia)
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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
  • Nearly everyone in the trial had some side effects
  • People in the TUKYSA clinical study were not required to take an antidiarrheal medicine
  • 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

Side Effects: Unwanted reactions to a drug; common side effects are those that happen often and to many people; some side effects may be serious and require emergency medical care.

Hair loss was not common in people in either of the two treatment groups (4.7% of people treated with TUKYSA, along with trastuzumab and capecitabine, had hair loss versus 3.6% of people treated with trastuzumab and capecitabine alone) in the clinical study.

Important Safety Information

Caution icon

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.