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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.

ONLINE PRIVACY POLICY

Genentech, Inc. ("Genentech") respects the privacy of visitors to its websites, and we recognize your need for appropriate protection and management of personally identifiable information you share with us (any information by which you can be identified, including but not limited to, name, address, e-mail address, and telephone number). We have established this Online Privacy Policy so that you are informed about how we treat any personally identifiable information that you provide to us in the course of using this website. This Online Privacy Policy will inform you of:

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Please note that the Genentech websites are directed towards users who reside in the United States of America. It is not our intent to gather personally identifiable information from individuals residing outside the U.S.

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Genentech is the owner of all information collected on this website. In addition to the purposes described above, any information we collect may also be used for analytics purposes (e.g., evaluating site usage patterns, assessing throughput) so that we can gauge the effectiveness of our programs and improve the usefulness of information presented to users.

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Our websites are not intended for or designed to attract children under the age of 13. Moreover, we do not knowingly collect any personally identifiable information from anyone under the age of 18 without the consent of a parent or guardian, and you must be 18 years of age or older to submit registration or survey information. Should you believe that a minor of whom you are a parent or guardian has registered, please contact us at privacy.office@gene.com and we will make reasonable efforts to remove all personally identifiable information related to the minor.

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This website and emails we send to you may contain transparent GIF files (also known as "web beacons," "action tags," or "pixel tags") to help manage online advertising. These GIF files are used by us and our ad management partners to recognize when a visitor views a web page or opens an email. This information enables us to learn which emails and advertisements bring users to our website. The information collected and shared with our ad management partners through the use of GIF files is anonymous and is not personally identifiable.

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We may track the total number of visitors to our website, the number of visitors to each page of our website, IP addresses, and the domain names of our users' Internet Service Providers, and we may analyze these data for trends and statistics in the aggregate, but such information will be in aggregate form only and it will not contain personally identifiable data. Such aggregate information is not linked to any personally identifiable information that can identify any individual person.

We may use such aggregate information to analyze trends, administer the website, track users' movement, and gather broad demographic information for aggregate use. We may share this aggregate information with our corporate partners and contracted vendors to assist us in operating the website and to enable them to better understand Genentech's business.

Sharing and Disclosure

We may provide your personally identifiable information that we collect and the data generated by cookies to a parent, subsidiary or affiliate entity within the Genentech corporate family, partner entities, and the vendors and service agencies that we may engage to assist us. For example, we may provide your personally identifiable information to an organization in order to complete a service (e.g., send out newsletter e-mails you have requested), to assist us in reviewing the data or to provide marketing or advertising on our behalf. Any organization to which we provide such personally identifiable information is also required to keep your personally identifiable information confidential in accordance with this Online Privacy Policy. We will also disclose your personally identifiable information to respond to appropriate requests of government agencies or if we reasonably believe we are required to do so by law, regulation or other government authority (such as reporting safety information to the Food and Drug Administration). We will not sell your personally identifiable information to any other company or organization except we may transfer your personally identifiable information to a successor entity upon a merger, consolidation or other corporate reorganization in which Genentech participates or to a purchaser of all or substantially all of Genentech's assets. Such successor entity shall be bound by the terms and conditions of this Online Privacy Policy.

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Genentech is committed to respecting your right to access and correct your personal information. You can call us at 877-GENENTECH and we will be happy to assist you with your request.

You may also "opt-out" of receiving e-mails and other communications from us by using the unsubscribe feature included in the e-mails we send.

Contacting Genentech

If you have any questions about this online privacy policy or the information practices of our sites, you may contact us by email at privacy.office@gene.com or by mail at:

Genentech, Inc.
Attn: Privacy Office
1 DNA Way
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Privacy Policy last updated: February 4, 2011

  • Revised sections 'Online Privacy Policy Updates,' 'Information Collection and Use,' 'Minors,' 'Cookies and GIF Files,' 'Sharing and Disclosure,' and 'Correcting/Updating Personally Identifiable Information'
  • Added section 'Contacting Genentech'

Previous update: July 12, 2004

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

Patient Support App

Help for women with HER2+ Breast Cancer

Whether you'd like to get information, relax with a soothing meditation, or connect with others for support, 4HER is here for you.

Developed by Genentech (with some content in collaboration with Breastcancer.org), this easy-to-use app is exclusively for women with HER2+ Breast Cancer.

  • Find information about Breast Cancer
  • Explore questions to ask your doctor
  • Discover support resources and register for HERConnection, a free educational program that supports patients on select Genentech HER2+ Breast Cancer treatments
  • Play a game whenever you need a break
  • Relax with guided meditation
  • Connect with others, and more

Download this FREE app today! (iPhone® only)