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What are the possible side effects of TUKYSA?

TUKYSA can cause serious side effects, including:


  • Diarrhea (watery, loose or frequent stools) is common and can sometimes be serious. To say your health care provider if you have a change in your stools or severe diarrhea. Severe diarrhea can lead to excessive loss of 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 you start 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 (tea-colored) urine, pain or discomfort in the right upper part of the stomach (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 the soles of your feet
  • nausea
  • tired
  • increased liver function blood tests
  • vomiting
  • mouth sores (stomatitis)
  • decreased appetite
  • pain in the stomach area (abdomen)
  • headache
  • a low number of red blood cells (anemia)
  • eruption


Your healthcare provider may change your dose of TUKYSA, temporarily stop, or permanently stop treatment with TUKYSA if you experience certain side effects.

TUKYSA can cause fertility problems in both men and women, which may affect the ability to have children. Talk to your healthcare provider if you have any concerns about fertility.

These are not all the possible side effects of TUKYSA. Discuss side effects with your healthcare provider. We encourage you 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 your medical conditions, including if you:

  • have liver problems.
  • are pregnant or plan to become pregnant. TUKYSA may harm your unborn baby.

  • Women capable of becoming pregnant: Your healthcare provider will perform a pregnancy test before you start taking TUKYSA. Use effective birth control (contraception) during treatment with TUKYSA 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 might be pregnant while taking TUKYSA.

  • Men with a female partner who can get pregnant: Use effective contraception during treatment with TUKYSA and for at least 1 week after the last dose of TUKYSA.
  • are breastfeeding (breastfeeding) or planning to breastfeed. Do not breast-feed during treatment with TUKYSA and for at least 1 week after the last dose of TUKYSA.

Tell your healthcare professional about all medications you are taking, including prescription and over-the-counter medications, vitamins and herbal supplements. TUKYSA can affect how your other medicines work, and other medicines can affect how TUKYSA works. Keep a list of all the medications you take and show it to your healthcare professional and pharmacist each time you receive a new medication.

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 which cannot be surgically removed and who have received one or more anti-HER2 treatments for breast cancer.

It is not known if TUKYSA is safe and effective in children.

Please see Important Facts about TUKYSA.

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