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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.

Download the full Prescribing Information View full safety information ›

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About Herceptin

Proven targeted therapy for your kind of cancer

Proven targeted therapy

Herceptin is a targeted therapy approved for the treatment of people with certain HER2+ cancers. HER2+ cancer cells have more HER2 receptors (a particular protein found on the surface of cells) than normal cells. HER2+ cancer is considered aggressive because it grows and spreads quickly.

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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 1 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 1 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.

Learn more about adjuvant breast cancer treatment ›

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 1 or more chemotherapy courses for metastatic disease

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

Learn more about metastatic breast cancer treatment ›

Metastatic Gastric/GEJ 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.

Learn more about metastatic gastric/GEJ cancer treatment ›

Serious Side Effect: Heart Monitoring

  • Your doctor will evaluate your heart function before and during 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

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Herceptin is targeted therapy for HER2+ cancer

In addition to traditional therapies, there are targeted therapies that target cells with specific proteins (such as receptors) for treatment. Some targeted therapies such as Herceptin target HER2 receptors, which may help keep the cancer from growing.1,2

References
  1. Herceptin Prescribing Information. Genentech, Inc. October 29, 2010.
  2. Treatment option overview. National Cancer Institute website. http://www.cancer.gov/cancertopics/pdq/treatment/breast/Patient/page5. Accessed November 17, 2010.

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Treatment Definitions

Targeted Therapies1

  • Targeted therapy is different from other types of therapy. Targeted therapy is designed to target cells with specific receptors for treatment

Traditional Therapies1

  • Radiation therapy uses high-energy rays to kill cells and/or shrink tumors
  • Chemotherapy is drugs that are used to destroy cells
  • Hormonal therapy* helps fight tumors that thrive on hormones like estrogen or progesterone by acting on hormone receptors on tumor cells or by decreasing the amount of estrogen available to bind to these receptors

Based on your needs, your doctor may choose 1 or more of these treatments for you.
* Breast cancer only.

References
  1. Treatment option overview. National Cancer Institute website. http://www.cancer.gov/cancertopics/pdq/treatment/breast/Patient/page5. Accessed November 17, 2010.

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How Herceptin may work1,2

How Herceptin may work MOA diagram

Serious Side Effects: Infusion Reactions and Lung Problems

  • 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
References
  1. Herceptin Prescribing Information. Genentech, Inc. October 29, 2010.
  2. Pegram M, Slamon D. Biological rationale for HER2/neu (c-erbB2) as a target for monoclonal antibody therapy. Semin Oncol. 2000;27(suppl 9):13-19.

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HER2 Testing

If you are unsure of your cancer's HER2 status, you should talk to your doctor. HER2+ cancer is aggressive, so it is important to find out your cancer's HER2 status as soon as possible. This can help your doctor choose which treatments may be right for you.

HER2 testing is performed with the tumor sample removed during surgery or using a needle.

There are 2 types of tests available to determine HER2 status:

  • A Fluorescence In Situ Hybridization (FISH) test checks to see whether or not the cancer cells have a normal number of HER2 genes. Using a special microscope, the pathologist looks at cancer cells to see how many HER2 genes there are compared with some other normal genes
  • An ImmunoHistoChemistry (IHC) test measures how much HER2 protein there is on the surface of the cancer cells. The test is scored on a scale of 0 to 3+

Quality testing is important. Sometimes 1 test may not be enough to determine with certainty whether your tumor is HER2+. Ask your doctor to discuss the results of your pathology report, explain how your tumor's HER2 status was determined, and to let you know whether another test may be necessary.

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Important safety information you should know about Herceptin

As a treatment, Herceptin does involve risks. Serious side effects have occurred in people treated with Herceptin. Speak to a member of your healthcare team to learn more.

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

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More Information

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 MotHER—the Herceptin 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
  • Fatigue
  • 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
  • Fatigue
  • 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 MotHER—the Herceptin 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.

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


Herceptin

Herceptin

For additional support: Call 866.449.HER2 Chat with Nurse