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What side effects can TUKYSA have?

TUKYSA can cause serious side effects, including:

  • diarrhea (watery, soft, or frequent stools) is common and can sometimes be severe. Tell Contact your doctor if you have a change in your bowel movements or severe diarrhea. Severe diarrhea can cause loss of too much body fluid (dehydration), low blood pressure, kidney problems, and death. Your doctor may prescribe medicines to treat your diarrhea while you are being treated with TUKYSA.

  • liver problems, including severe cases. Your doctor will test your blood to check your liver function before starting and every 3 weeks during treatment with TUKYSA or as needed. Tell your doctor right away if you have 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 upper right abdomen, feeling very tired, decreased appetite or lighter than bleed or bruise normally.

The most common side effects of TUKYSA:

  • diarrhea
  • Rash, redness, pain, swelling or blistering on the palms of your hands or soles of your feet
  • nausea
  • fatigue
  • increased liver function blood tests
  • Vomit
  • mouth sores (stomatitis)
  • decreased appetite
  • abdominal pain (abdominal pain).
  • headache
  • a low number of red blood cells (anaemia)
  • rash

Your doctor may change your TUKYSA dose, temporarily stop TUKYSA treatment, or permanently stop it if you experience certain side effects.

TUKYSA can cause fertility problems in both men and women, which can affect their ability to have children. Talk to your doctor if you have concerns about fertility.

These are not all possible side effects of TUKYSA. Discuss side effects with your doctor. 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 doctor before taking TUKYSA?

Tell your doctor about all your medical conditions before taking TUKYSA, even if you have:

  • have liver problems.
  • are pregnant or planning to become pregnant. TUKYSA may harm your unborn child.

  • Women who can become pregnant: Your doctor will do a pregnancy test before you start taking TUKYSA. Use effective contraception (contraception) during treatment with TUKYSA and for at least 1 week after the last dose of TUKYSA. Tell your doctor right away if you become pregnant or think you may be pregnant while being treated with TUKYSA.

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

Tell your doctor about all medicines you are taking including prescription and over-the-counter medicines, vitamins and herbal supplements. TUKYSA can affect the way your other medicines work, and other medicines can affect the way TUKYSA works. Keep a list of all the medicines you are taking and show it to your doctor and pharmacist each time you are given a new medicine.


What is TUKYSA?

TUKYSA is a prescription medicine that is used along with the medicines trastuzumab and capecitabine to treat adults with human epidermal growth factor receptor 2 (HER2)-positive breast cancer that has spread (metastatic) to other parts of the body such as the brain or this have been surgically removed and have received one or more treatments for HER2 breast cancer.

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

See Important facts about TUKYSA.

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