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Side effects and safety

TYKERB may cause side effects. Some of these side effects can be serious. Serious side effects include:

  • Heart problems
    • Decreased pumping of blood from the heart
    • Abnormal heartbeat

    Call your doctor right away if you are short of breath, have a rapid heartbeat (palpitations), or feel very tired.

  • Lung problems
  • Severe diarrhea

    • This can cause your body to lose too much fluid (dehydration). Call your doctor right away if you have severe diarrhea.1

More common side effects

Some of the common side effects of TYKERB in combination with Xeloda1 include:

  • Diarrhea. In most cases, diarrhea is mild or moderate, but in a few cases it can be severe
  • Red, painful hands and feet (hand-foot syndrome)
  • Feeling sick to your stomach (nausea)
  • Rash
  • Vomiting
  • Tiredness (fatigue)
  • Mouth sores
  • Loss of appetite
  • Indigestion

These are not all of the possible side effects of TYKERB.1 Ask your doctor for more information. Not everyone taking TYKERB will have side effects. Learn more about managing treatment effects.

You may have side effects associated with Xeloda therapy. Talk with your doctor about these possible side effects. Be sure to ask your doctor to provide you with information about Xeloda.



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Indication

TYKERB is indicated in combination with Xeloda® (capecitabine) for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and Herceptin® (trastuzumab).

Important Safety Information

Before taking TYKERB, tell your doctor if you have heart problems. As with other treatments for HER2-positive advanced or metastatic breast cancer, there have been reports of changes in how the heart pumps blood through the body and how the heart beats. Call your doctor right away if you are short of breath, have rapid heartbeats (palpitations), or feel very tired.

Tell your doctor if you have liver problems. People who have liver problems may not be able to process TYKERB well, so you may need a lower dose of TYKERB.

Some people taking TYKERB have reported diarrhea. In some cases, diarrhea can be severe. Call your doctor right away if you have diarrhea. It is important to manage diarrhea with medicine as soon as it begins. Severe diarrhea may need to be treated with electrolytes and fluids given by mouth or by vein. Treatment with TYKERB may have to be delayed for a while or stopped completely.

If you have a dry cough or have shortness of breath, talk with your doctor. These may be signs of inflammation in the lungs.

Women should not become pregnant when taking TYKERB because the unborn baby may be harmed.

The most common side effects reported by patients taking TYKERB and Xeloda were diarrhea; vomiting; feeling sick to your stomach (nausea); feeling tired; red, painful hands and feet; and rash.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines and herbal and dietary supplements.

Because TYKERB is currently indicated to be taken with another medicine called Xeloda, be sure to talk with your doctor about any medicines and supplements that should be avoided when taking Xeloda.

Please see complete US Prescribing Information for TYKERB.

Herceptin is a registered trademark of Genentech, Inc.
Xeloda is a registered trademark of Roche Laboratories Inc.

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