Support for Women with HER2+ Breast Cancer
Genentech, USA, Inc.
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HER2-positive or HER2+
Breast cancer cells that have too many HER2 receptors.
Adjuvant treatment is additional treatment for early breast cancer that is given just after, and complementary to, the main treatment (usually surgery). For HER2+ breast cancer, this may include radiation therapy, chemotherapy, hormonal therapy, and/or targeted therapy.
A type of protein that is found on the surface of cells in everyone. This protein tells cells to grow and divide. Too much HER2 is called “HER2 overexpression.”
Metastatic breast cancer
Breast cancer that has spread outside the breast to other parts of the body, such as the lungs, liver, or bones.
Monoclonal antibody cancer therapy
A molecule that is made to target specific cancer cells and may affect normal cells.
A type of cancer treatment that kills cells that grow and divide rapidly. This can include cancer cells or normal cells.
Intravenous (IV) infusion
Getting medicine through a needle directly into a vein. Some medicines, such as KADCYLA, can only be given by IV infusion.
Your body’s natural defense against infections and disease.
KADCYLA approved to treat HER2-positive breast cancer that has spread to other parts of the body (metastatic breast cancer) after prior treatment with trastuzumab (Herceptin®) and a taxane. Prior treatment could have been for the initial treatment of breast cancer or for the treatment of cancer that had spread to other parts of the body.
KADCYLA (ado-trastuzumab emtansine)
Not all people have serious side effects; however, side effects with KADCYLA treatment are common. It is important to know what side effects may happen and what symptoms you should watch for.
You must have a HER2 test to determine if your cancer is HER2-positive before taking KADCYLA, because benefit has been shown only in patients whose tumors are HER2-positive.
The most common severe side effects of KADCYLA are:
The most common side effects seen in people taking KADCYLA were:
You are encouraged to report side effects to Genentech and the FDA. You may contact Genentech by calling 1-888-835-2555. You may contact the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.
Please see KADCYLA full Prescribing Information, including Most Important Safety Information, for additional Important Safety Information.
PERJETA® (pertuzumab) is approved for use in combination with Herceptin®(trastuzumab) and docetaxel in people who have HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer.
PERJETA® (pertuzumab) is approved for use prior to surgery in combination with Herceptin® (trastuzumab) and docetaxel in people with HER2-positive, locally advanced, inflammatory, or early stage (tumor is greater than 2 cm in diameter or node positive) breast cancer. PERJETA should be used as part of a complete treatment regimen for early stage breast cancer. This use of PERJETA is based on an improvement in the percentage of patients whose cancer shrinks or disappears after treatment. Currently, no data have shown whether or not treatment with PERJETA prior to surgery improves survival.
PERJETA may cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure).
Receiving PERJETA during pregnancy can result in the death of an unborn baby and birth defects.
PERJETA has only been shown to work in people with HER2-positive breast cancer. You must have a HER2 test to know if your breast cancer is HER2-positive before receiving an anti-HER2 treatment, such as PERJETA.
The most common side effects of PERJETA when given with Herceptin and docetaxel for treatment of breast cancer that has spread to other parts of the body (metastatic) are:
The most common side effects of PERJETA when given with Herceptin and docetaxel as part of an early breast cancer regimen before surgery are:
The most common side effects of PERJETA when given with Herceptin and docetaxel following 3 cycles of epirubicin, cyclophosphamide, and fluorouracil as part of an early breast cancer regimen before surgery are:
The most common side effects of PERJETA when given with Herceptin, docetaxel, and carboplatin as part of an early breast cancer regimen before surgery are:
You are encouraged to report side effects to Genentech and the FDA. You may report side effects to the FDA at (800) FDA-1088(800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-25551-888-835-2555.
Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information including most serious side effects.
Herceptin is approved for the treatment of early-stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+) and has spread into the lymph nodes, or is HER2-positive and has not spread into the lymph nodes. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high-risk feature.* Herceptin can be used in several different ways:
Patients are selected for therapy based on an FDA-approved test for Herceptin
*High risk is defined as ER/PR-positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3.
Herceptin has 2 approved uses in metastatic breast cancer:
Patients are selected for therapy based on an FDA-approved test for Herceptin
Herceptin is approved, in combination with chemotherapy (cisplatin and either capecitabine or 5-fluorouracil), for the treatment of HER2-positive metastatic cancer of the stomach or gastroesophageal junction (where the esophagus meets the stomach) in patients who have not received prior treatment for their metastatic disease.
Patients are selected for therapy based on an FDA-approved test for Herceptin.
Possible Serious Side Effects With HERCEPTIN
Not all people have serious side effects, but side effects with HERCEPTIN therapy are common.
Although some people may have a life-threatening side effect, most do not.
Your doctor will stop treatment if any serious side effects occur.
HERCEPTIN is not for everyone. Be sure to contact your doctor if you are experiencing any of the following:
These include heart problems—such as congestive heart failure or reduced heart function—with or without symptoms. The risk for and seriousness of these heart problems were highest in people who received both HERCEPTIN and a certain type of chemotherapy (anthracycline). In a study of adjuvant (early) breast cancer, one patient died of significantly weakened heart muscle. Your doctor will check for signs of heart problems before, during, and after treatment with HERCEPTIN.
These signs usually happen within 24 hours after receiving HERCEPTIN.
Be sure to contact your doctor if you:
Are a woman who could become pregnant, or may be pregnant
HERCEPTIN may result in the death of an unborn baby or birth defects. Contraception should be used while receiving HERCEPTIN and after your last dose of HERCEPTIN. If you are exposed to HERCEPTIN during pregnancy or within 7 months of becoming pregnant, you are encouraged to enroll in the MotHER Pregnancy Registry by contacting 1-800-690-67201-800-690-6720 or visiting http://www.motherpregnancyregistry.com/ and report HERCEPTIN exposure to Genentech at 1-888-835-25551-888-835-2555.
Have any signs of SEVERE LUNG PROBLEMS, including
Your doctor may check for signs of severe lung problems when he or she examines you.
Have LOW WHITE BLOOD CELL COUNTS
Low white blood cell counts can be life threatening. Low white blood cell counts were seen more often in patients receiving HERCEPTIN plus chemotherapy than in patients receiving chemotherapy alone.
Your doctor may check for signs of low white blood cell counts when he or she examines you.
Side Effects Seen Most Often With HERCEPTIN
Some patients receiving HERCEPTIN for breast cancer had the following side effects:
Some patients receiving HERCEPTIN for metastatic stomach cancer had the following side effects:
You should contact your doctor immediately if you have any of the side effects listed above.
You are encouraged to report side effects to Genentech and the FDA. You may report side effects to the FDA at 1-800-FDA-10881-800-FDA-1088 or http://www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-25551-888-835-2555.
Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information, including Boxed WARNINGS.