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SAFETY

What possible Serious Side Effects and Additional Important Safety Information should I know about Herceptin?

  • 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 to the fetus, when taken by a pregnant woman
  • Worsening of low white blood cell counts associated with chemotherapy has also occurred
  • You must have a HER2 test to determine if your cancer is HER2-positive before taking Herceptin
  • The most common side effects associated with Herceptin in patients with breast cancer are fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, shortness of breath, rash, low white and red blood cell counts, and muscle pain
  • The most common side effects associated with Herceptin in patients with stomach cancer are low white and red blood cell counts, diarrhea, fatigue, 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, and a change in taste

Because everyone is different, it is not possible to predict what side effects any one person will have. If you have questions or concerns about side effects, you should talk to your doctor.

Please see full Prescribing Information for Serious Side Effects and additional important safety information.

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

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Herceptin and Metastatic Gastric/GEJ Cancer

Proven targeted therapy

Herceptin is the first and only monoclonal antibody therapy approved for the treatment of HER2+ metastatic gastric 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 989,000 new cases of stomach cancer are diagnosed each year worldwide, of which 21,000 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

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:4
    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

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.5,6

  • 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 website. http://seer.cancer.gov/statfacts/html/stomach.html. Accessed October 6, 2010.
  2. Stomach cancer incidence and mortality worldwide in 2008 summary. International Agency for Research on Cancer website. http://globocan.iarc.fr/factsheets/cancers/stomach.asp. Accessed October 6, 2010.
  3. Jørgensen JT. Targeted HER2 treatment in advanced gastric cancer. Oncology. 2010;78:26-33.
  4. Herceptin Prescribing Information. Genentech, Inc. October 29, 2010.
  5. NCCN Clinical Practice Guidelines in Oncology™: Gastric Cancer. V.2.2011. Accessed August 1, 2011.
  6. 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. October 29, 2010.

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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+ 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 Adriamycin® (doxorubicin), Cytoxan® (cyclophosphamide), and either Taxol® (paclitaxel) or Taxotere® (docetaxel). This treatment course is known as "AC→TH."
  • With the chemotherapy drugs Taxotere and Paraplatin® (carboplatin). This treatment course is known as "TCH."
  • Alone after treatment with multiple other therapies, including an anthracycline (Adriamycin)-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.
Adriamycin is a registered trademark of Pharmacia, Inc.
Cytoxan, Taxol, and Paraplatin are registered trademarks of Bristol-Myers Squibb Company.
Taxotere is a registered trademark of sanofi-aventis U.S. LLC.

Metastatic Breast Cancer

Herceptin has 2 approved uses in metastatic breast cancer:

  • Herceptin in combination with the chemotherapy drug Taxol® (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+ breast cancer in patients who have received one or more chemotherapy courses for metastatic disease.

Taxol is a registered trademark of Bristol-Myers Squibb Company.

Gastric Cancer

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.


What are the possible Serious Side Effects of Herceptin?

Heart Problems

  • 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.
  • Herceptin can cause serious heart problems, including:
    • A decline in heart function
    • Irregular heartbeats
    • High blood pressure
    • Serious heart attack
    • Death
  • Your doctor will stop Herceptin therapy if you have weakening of the heart muscle or changes in the heart muscle structure.

Monitoring the Heart

  • 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 may run tests, such as an echocardiogram or a MUGA scan, and will review your health history to see how well the heart muscle is working.
  • If you are taking Herceptin and have stopped treatment temporarily because of significant heart problems, your doctor should monitor your heart health more frequently.

Infusion Reactions

  • Some patients have had serious infusion reactions and lung problems; infusion reactions leading to death have been reported.
  • Symptoms usually happen during or within 24 hours of taking Herceptin.
  • Your infusion should be temporarily stopped if you experience shortness of breath or very low blood pressure.
  • Your doctor should monitor you until these symptoms completely go away.
  • Your doctor may have you completely stop Herceptin treatment if you have:
    • A severe allergic reaction
    • Swelling
    • Lung problems
    • Swelling of the lungs
    • Severe shortness of breath
  • Infusion reaction symptoms consist of:
  • Fever and chills
  • Nausea
  • Vomiting
  • Pain (in some cases at tumor sites)
  • Headache
  • Dizziness
  • Shortness of breath
  • Very low blood pressure
  • Rash
  • Lack of energy and strength

Pregnancy

  • Herceptin can cause harm to the fetus (unborn baby), in some cases death to the fetus, when taken by a pregnant woman.
  • You should use effective birth control methods while receiving Herceptin and for at least 6 months after you finish taking Herceptin.
  • Nursing mothers taking Herceptin may want to stop nursing or stop Herceptin, depending on the importance of the drug to the mother.
  • Women exposed to Herceptin during pregnancy may wish to enroll in the MotHER Pregnancy Registry by calling 1 (800) 690-6720.

Taking Herceptin Can Result in Serious and Potentially Deadly Lung Problems, Including:

  • A severe shortness of breath
  • Fluid in or around the lungs
  • Weakening of the valve between the heart and the lungs
  • Too little oxygen in the body
  • Swelling of the lungs
  • Scarring of the lungs

Problems like these may occur after an infusion reaction. If you have trouble breathing at rest due to existing lung disease, or large lung tumors appear, you may have more serious lung problems. Your doctor should stop Herceptin if you experience lung problems.

What is the Additional Important Safety Information associated with Herceptin?

Worsening of Low White Blood Cell Counts Due to Chemotherapy

  • Worsening of low white blood cell counts to serious and life-threatening levels and associated fever were higher in patients taking Herceptin in combination with chemotherapy when compared with those who received chemotherapy alone. The likelihood that a patient will die from infection was similar among patients who received Herceptin and those who did not.

HER2 Testing

  • You must have a HER2 test to determine if your cancer is HER2-positive before taking Herceptin, as benefit has only been shown in patients whose tumors are HER2-positive.

What Are the Most Common Side Effects Associated with Herceptin?

The most common side effects associated with Herceptin in patients with metastatic stomach cancer are: The most common side effects associated with Herceptin in patients with breast cancer are:
  • 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
  • Fever
  • Nausea
  • Vomiting
  • Infusion reactions
  • Diarrhea
  • Infections
  • Increased cough
  • Headache
  • Feeling tired
  • Shortness of breath
  • Rash
  • Low white and red blood cell counts
  • Muscle pain

What should I look for when I'm on Herceptin therapy, and what symptoms should I immediately report to my doctor?

Patient Counseling Information

  • You should contact your doctor immediately for any of the following:
    • New onset or worsening shortness of breath
    • Cough
    • Swelling of the ankles/legs
    • Swelling of the face
    • Palpitations
    • Weight gain of more than 5 pounds in 24 hours
    • Dizziness or loss of consciousness
  • If you are pregnant or of childbearing potential, you should know that Herceptin exposure can result in harm to the fetus (unborn baby).
  • You should use effective birth control methods during treatment and for a minimum of six months following Herceptin.
  • If you are nursing your baby, you should stop taking Herceptin or stop nursing.
  • If you are exposed to Herceptin during pregnancy, you should enroll in the MotHER Pregnancy Registry by calling 1 (800) 690-6720.

Because everyone is different, it is not possible to predict what side effects any one person will have. If you have questions or concerns about side effects, you should talk to your doctor.

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 full Prescribing Information for Serious Side Effects and additional important safety information.

Herceptin

Herceptin

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