Testing for HER2+ (HER2-positive) cancer
HER2 testing can be performed on a new or stored sample of a tumor removed during biopsy or surgery. Currently, there are two different tests available to diagnose tumors as HER2+.19 The pathologist's report will indicate which test was performed.
Immunohistochemistry (IHC)
IHC testing measures how much HER2 protein is present in a tumor sample. The results of IHC are graded from 0 to 3+.
| Grade | HER2 Protein Expression | Status |
|---|---|---|
| 0 to 1+ | Normal | HER2- |
| 2+ | Moderate* | HER2- |
| 3+ | High | HER2+ |
*If you have a grade of 2+, it is recommended to confirm this with FISH testing.
Fluorescence In-Situ Hybridization (FISH)
FISH measures the amount of the HER2/neu gene, the gene responsible for producing HER2 receptors in each cell. Unlike IHC testing, there is no grading scale. If two copies of the gene are found in a cell, it is HER2-. If more than two copies are found, it is HER2+.20
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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
Some women may develop liver damage while taking TYKERB. The cause of this damage is not known. In some cases, liver damage may be severe and may cause death. Your doctor should test your liver before and during treatment with TYKERB to check for signs of liver damage. You should contact your doctor if you have itching, yellow eyes or skin, dark urine, pain in your right upper side of your belly or feel very tired. If you develop liver damage during your treatment, your doctor may tell you to stop taking TYKERB. Before taking TYKERB, tell your doctor if you have liver problems. You may need a lower dose of TYKERB.
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.
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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