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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.

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:

  1. How you will be informed of updates to this Online Privacy Policy
  2. What personally identifiable information of yours we may collect from you through our website
  3. How we may use your personally identifiable information
  4. Limits on how we would share and disclose your personally identifiable information
  5. Our policy regarding links to third party websites
  6. Security of our website
  7. How you can correct and update your personally identifiable information

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.

Online Privacy Policy Updates

From time to time, Genentech may revise this Online Privacy Policy. Any such changes to this Online Privacy Policy will be promptly reflected on this page. Genentech encourages you to review this Online Privacy Policy regularly for any changes. Your continued use of this website will be subject to the then-current Online Privacy Policy. The effective date of this Online Privacy Policy is December 9, 2010.

Information Collection and Use

You can generally visit our website without revealing any personally identifiable information about yourself. However, to access certain options and services we may ask you to provide certain personally identifiable information and without providing such personally identifiable information, you may be unable to access certain options and services. We (along with our third party partners engaged to provide marketing and advertising on our behalf) collect personally identifiable information about you only if you voluntarily provide it to us and you have the option not to provide any personally identifiable information to us. The following is personally identifiable information that you may voluntarily provide to us and how we use it:

  • Surveys. Information obtained from you on web surveys, such as contact information (name and shipping address), demographic information (zip code, age level) and medical condition. We may use this personally identifiable information to provide you with information and services for which you have expressed an interest or that you may find useful based on your answers in a survey. Additionally, we may refer to your personally identifiable information to better understand your needs and how we can improve our website.
  • Newsletters. Information obtained from your request to subscribe to a newsletter, such as contact information (name and e-mail address). We may use this personally identifiable information to deliver the newsletters that you have elected to receive.
  • Registration. Information obtained from you on registration forms used to process your requests for services and information, such as contact information (name, address, e-mail address), password, username or code, age, date of birth, gender, ethnicity and medical condition. This registration information may also be gathered if you register for certain services via fax or mail. We may use this information to send you a welcoming e-mail to verify your username and password, website updates, special offers, notices regarding relevant medical conditions and treatment, or other information responsive to the data that you provide to us. Additionally, we may refer to your personally identifiable information to better understand your needs and how we can improve our website.
  • E-mail Content to a Friend. Information obtained from you regarding friend or family name and e-mail address, if you elect to use our referral service for sending some of our website content to friends and family. This personally identifiable information will be used to automatically send the friend or family member an e-mail from you inviting them to visit the website. We may store this information for the sole purpose of sending this one-time e-mail.

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.

Minors

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.

Cookies and GIF Files

Some of our websites may use cookie technology to identify users who have previously visited so the user is recognized upon return, thereby saving them time while on our website. A cookie is a piece of data stored on the user's hard drive containing information about the user. Usage of a cookie is in no way linked to any personally identifiable information while on our website. If a user rejects the cookie, they may still use our website. A cookie may be placed by us, or by vendors or service agencies who work with us or with our partners.

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.

Log Files and Aggregate Information

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.

Links to Third Party Sites

Some of our websites may contain links to other websites on the Internet that are not under the control of or maintained by Genentech. Such links do not constitute an endorsement by Genentech of those other websites, the content displayed therein, or the persons or entities associated therewith. You acknowledge that Genentech is providing these links to you only as a convenience, and you agree that Genentech is not responsible for the content of such websites. Your use of these other linked websites is subject to the respective terms of use and privacy policies located on the linked websites.

Security

Genentech and its third party providers may employ procedural and technological security measures, consistent with industry practice. Such measures are reasonably designed to protect your personally identifiable information from loss, unauthorized access, disclosure, alteration or destruction. Genentech may use encryption, password protection, secure socket layers, internal restrictions and other security measures to help prevent unauthorized access to your personally identifiable information.

Correcting/Updating Personally Identifiable Information

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
South San Francisco, CA 94080

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-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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