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SAFETY

Who is Herceptin for?

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:

  • As part of a treatment course including the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel. This treatment course is known as "AC→TH."
  • With the chemotherapy drugs docetaxel and carboplatin. This treatment course is known as "TCH."
  • Alone after treatment with multiple other therapies, including an anthracycline (doxorubicin)-based therapy (a type of chemotherapy).

*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.

Metastatic Breast Cancer

Herceptin has 2 approved uses in metastatic breast cancer:

  • Herceptin in combination with the chemotherapy drug paclitaxel is approved for the first line treatment of Human Epidermal growth factor Receptor 2-positive (HER2+) metastatic breast cancer.
  • Herceptin alone is approved for the treatment of HER2-positive breast cancer in patients who have received one or more chemotherapy courses for metastatic disease.

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.

Important Patient Safety Information

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:

  • Fever and chills
  • Feeling sick to your stomach (nausea)
  • Throwing up (vomiting)
  • Pain (in some cases at tumor sites)
  • Headache
  • Dizziness
  • Shortness of breath

These signs usually happen within 24 hours after receiving HERCEPTIN.

Be sure to contact your doctor if you:

Are BREAST-FEEDING OR PREGNANT
HERCEPTIN may harm a nursing child or an unborn baby.

Are PLANNING TO BECOME PREGNANT
Taking HERCEPTIN could result in death of an unborn baby or birth defects.

If you stop treatment with HERCEPTIN, you should keep using birth control for at least 6 months before trying to become pregnant. If you are exposed to HERCEPTIN during pregnancy, you are encouraged to enroll in the MotHER Pregnancy Registry by contacting 1-800-690-6720.

Have any signs of SEVERE LUNG PROBLEMS, including

  • Severe shortness of breath
  • Fluid in or around the lungs
  • Weakening of the valve between the heart and the lungs
  • Not enough oxygen in the body
  • Swelling of the lungs
  • Scarring of the lungs

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.

Other Important Information

Before taking HERCEPTIN, you must have a HER2 test to determine if your cancer is HER2-positive. This is because the benefit of treatment with HERCEPTIN has been shown only in patients whose tumors are HER2-postive.

Side Effects Seen Most Often With HERCEPTIN

Some patients receiving HERCEPTIN for breast cancer had the following side effects:

  • Fever
  • Feeling sick to your stomach (nausea)
  • Throwing up (vomiting)
  • Infusion reactions
  • Diarrhea
  • Infections
  • Increased cough
  • Headache
  • Feeling tired
  • Shortness of breath
  • Rash
  • Low white and red blood cell counts
  • Muscle pain

Some patients receiving HERCEPTIN for metastatic stomach cancer had the following side effects:

  • Low white blood cell counts
  • Diarrhea
  • Feeling tired
  • Low red blood cell counts
  • Swelling of the mouth lining
  • Weight loss
  • Upper respiratory tract infections
  • Fever
  • Low platelet counts
  • Swelling of the mucous membranes
  • Swelling of the nose and throat
  • Change in taste

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 www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see HERCEPTIN full Prescribing Information, including Serious Side Effects, for additional Important Safety Information.

Safety First! Before you start exploring, take the time to read the Important Safety Information. Roll over to read more.

Related Links & Downloads

Herceptin and Metastatic Stomach/GEJ Cancer

Proven targeted therapy

Herceptin is the first and only monoclonal antibody therapy approved for the treatment of HER2+ metastatic stomach or gastroesophageal junction (GEJ) cancer.

Who is Herceptin for?

Herceptin is approved, in combination with chemotherapy (cisplatin and either capecitabine or 5-fluorouracil), for the treatment of HER2+ 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.


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Stomach cancer overview

Stomach Diagram Image

Stomach cancer (also known as gastric cancer) is a common cancer. An estimated 952,000 new cases of stomach cancer are diagnosed each year worldwide, of which 22,220 cases occur in the United States.1,2

In the ToGA* study, 22% of patients screened had tumors that were HER2+, a specific kind of stomach cancer.3

* Study that led to the approval of Herceptin in stomach/gastric cancer.

Stomach cancers also include cancer of the gastroesophageal junction (also known as the GEJ), where the esophagus meets the stomach.4

Stomach cancers are often found at the metastatic stage, leading to poorer outcomes. A cancer’s stage refers to how much the cancer has grown and where it has spread. Staging systems help describe the cancer, so that your doctor can decide what treatments will be appropriate.4,5

  • Metastatic gastric (stomach or GEJ) cancer is cancer that began in the stomach or GEJ, but has spread to other parts of the body
  • GEJ stands for the gastroesophageal junction, which is the place in the body where the esophagus meets the stomach
  • HER2+ stomach or GEJ cancer is a type of cancer involving an abnormally high amount of HER2 receptors, which are proteins on the surface of cells that encourage cell growth

Serious Side Effect: Heart Monitoring

  • Your doctor will evaluate your heart function before and during treatment. For adjuvant breast cancer therapy, your doctor will also evaluate heart function after the end of treatment. Your doctor will stop Herceptin therapy if you exhibit weakening of the heart muscle or changes in the heart muscle structure
  • If you are taking Herceptin and have stopped treatment temporarily because of significant heart problems, your doctor should monitor your heart health more frequently
References
  1. SEER stat fact sheets: stomach. National Cancer Institute web site. http://seer.cancer.gov/statfacts/html/stomach.html. Accessed August 19, 2014.
  2. Stomach cancer incidence and mortality worldwide in 2012 summary. International Agency for Research on cancer. http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx#. Accessed August 19, 2014.
  3. Jørgensen JT. Targeted HER2 treatment in advanced gastric cancer. Oncology. 2010;78:26-33.
  4. NCCN Clinical Practice Guidelines in Oncology®: Gastric Cancer V.1.2013. http://www.nccn.org. Accessed March 13, 2013. © National Comprehensive Cancer Network, 2013. To view the most recent and complete version of the Guideline, go online to www.nccn.org.
  5. Wagner AD, Grothe W, Haerting J, Kleber G, Grothey A, Fleig WE. Chemotherapy in advanced gastric cancer: a systematic review and meta-analysis based on aggregate data. J Clin Oncol. 2006;24:2903-2909.

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What is HER2+ stomach/GEJ cancer and how is it different?

  • Not all stomach/GEJ cancers are the same
  • HER2+ stomach/GEJ cancer cells have more HER2 receptors (a particular protein found on the surface of cells) than normal stomach cells
  • Too many HER2 receptors send signals, causing cells to grow too quickly.
  • In the ToGA study, 22% of patients screened had tumors that were HER2+1

How do I know if I have HER2+ stomach/GEJ cancer and why is this important?

  • The following 2 types of tests can help determine HER2 status in stomach/GEJ cancer:2
    1. FISH (Fluorescence In Situ Hybridization)
    2. IHC (ImmunoHistoChemistry)
  • Knowing whether you have HER2+ stomach/GEJ cancer is important because it may help your doctor determine which treatment option is right for you. If you are HER2+, Herceptin may be a treatment for you

If you have any questions about these tests or about your HER2 status, ask your doctor. He or she will determine the best way to find out whether you have HER2+ stomach/GEJ cancer and which treatment option may be best for you.

References
  1. Jørgensen JT. Targeted HER2 treatment in advanced gastric cancer. Oncology. 2010;78:26-33.
  2. Herceptin Prescribing Information. Genentech, Inc. June 2014.

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Important safety information you should know about Herceptin

Serious Side Effects

  • Herceptin treatment can result in heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure). The risk and seriousness of these heart problems were highest in people who received both Herceptin and a certain type of chemotherapy (anthracycline). One patient died in an adjuvant (early) breast cancer trial of significantly weakened heart muscle
  • Your doctor will evaluate your heart function before and during treatment. For adjuvant breast cancer therapy, your doctor will also evaluate heart function after the end of treatment. Your doctor will stop Herceptin therapy if you have serious weakening of the heart muscle or changes in the heart muscle structure
  • Some patients have had serious infusion reactions and lung problems; infusion reactions leading to death have been reported. Your doctor may have you completely stop Herceptin treatment if you have a severe allergic reaction, swelling, lung problems, swelling of the lungs, or severe shortness of breath
  • Herceptin can cause harm to the fetus (unborn baby), in some cases death of the fetus, when taken by a pregnant woman

Who is Herceptin for?

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:

  • As part of a treatment course including the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel. This treatment course is known as "AC→TH."
  • With the chemotherapy drugs docetaxel and carboplatin. This treatment course is known as "TCH."
  • Alone after treatment with multiple other therapies, including an anthracycline (doxorubicin)-based therapy (a type of chemotherapy).

*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.

Metastatic Breast Cancer

Herceptin has 2 approved uses in metastatic breast cancer:

  • Herceptin in combination with the chemotherapy drug paclitaxel is approved for the first line treatment of Human Epidermal growth factor Receptor 2-positive (HER2+) metastatic breast cancer.
  • Herceptin alone is approved for the treatment of HER2-positive breast cancer in patients who have received one or more chemotherapy courses for metastatic disease.

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.

Important Patient Safety Information

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:

  • Fever and chills
  • Feeling sick to your stomach (nausea)
  • Throwing up (vomiting)
  • Pain (in some cases at tumor sites)
  • Headache
  • Dizziness
  • Shortness of breath

These signs usually happen within 24 hours after receiving HERCEPTIN.

Be sure to contact your doctor if you:

Are BREAST-FEEDING OR PREGNANT
HERCEPTIN may harm a nursing child or an unborn baby.

Are PLANNING TO BECOME PREGNANT
Taking HERCEPTIN could result in death of an unborn baby or birth defects.

If you stop treatment with HERCEPTIN, you should keep using birth control for at least 6 months before trying to become pregnant. If you are exposed to HERCEPTIN during pregnancy, you are encouraged to enroll in the MotHER Pregnancy Registry by contacting 1-800-690-6720.

Have any signs of SEVERE LUNG PROBLEMS, including

  • Severe shortness of breath
  • Fluid in or around the lungs
  • Weakening of the valve between the heart and the lungs
  • Not enough oxygen in the body
  • Swelling of the lungs
  • Scarring of the lungs

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.

Other Important Information

Before taking HERCEPTIN, you must have a HER2 test to determine if your cancer is HER2-positive. This is because the benefit of treatment with HERCEPTIN has been shown only in patients whose tumors are HER2-postive.

Side Effects Seen Most Often With HERCEPTIN

Some patients receiving HERCEPTIN for breast cancer had the following side effects:

  • Fever
  • Feeling sick to your stomach (nausea)
  • Throwing up (vomiting)
  • Infusion reactions
  • Diarrhea
  • Infections
  • Increased cough
  • Headache
  • Feeling tired
  • Shortness of breath
  • Rash
  • Low white and red blood cell counts
  • Muscle pain

Some patients receiving HERCEPTIN for metastatic stomach cancer had the following side effects:

  • Low white blood cell counts
  • Diarrhea
  • Feeling tired
  • Low red blood cell counts
  • Swelling of the mouth lining
  • Weight loss
  • Upper respiratory tract infections
  • Fever
  • Low platelet counts
  • Swelling of the mucous membranes
  • Swelling of the nose and throat
  • Change in taste

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 www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see HERCEPTIN full Prescribing Information, including Serious Side Effects, for additional Important Safety Information.

http://www.herceptin.com

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