Adjuvant Breast Cancer
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, or tumor grade 2 or 3.
Metastatic Breast Cancer
Herceptin has 2 approved uses in metastatic breast cancer:
Patients are selected for therapy based on an FDA-approved test for Herceptin
Gastric Cancer
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:
HEART PROBLEMS
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.
INFUSION REACTIONS, including:
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 for 7 months after your last dose of HERCEPTIN. If you are or become pregnant while receiving HERCEPTIN or within 7 months after your last dose of HERCEPTIN, you should immediately report HERCEPTIN exposure to Genentech at 1-888-835-2555.
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–1088 or http://www.fda.gov/medwatch.
You may also report side effects to Genentech at 1–888–835–2555.
Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information, including Boxed WARNINGS.