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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.

Patient Coverage and Support

Financial and insurance coverage

Helping patients access our medicine, regardless of their ability to pay.

Herceptin® Access Solutions®

Herceptin® Access Solutions®

Herceptin® Access Solutions® helps to resolve specific access and reimbursement issues for individual patients every day. Our dedicated Specialists help bring patient treatment and practice solutions together.

Our staff can help:

  • Resolve benefits and coverage issues
  • Find co-pay assistance for underinsured patients
  • Individualize services to meet patients' specific needs

To speak live with one of our Specialists, call 1-888-249-4918 (weekdays 6AM-5PM PST), or fax 1-888-249-4919.

Learn more at www.genentech-access.com/herceptin/patients.

The Access Solutions logo is a registered trademark of Genentech Inc.

Genentech® Access to Care Foundation (GATCF)*:
Helping patients have access to Herceptin

Genentech® Access to Care Foundation (GATCF)

The Genentech® Access to Care Foundation (GATCF) was established to help patients with unmet medical needs who are uninsured or rendered uninsured by payer denial and who meet specific financial and medical criteria to receive proper medical treatment.

GATCF phone: 1-800-530-3083
GATCF fax: 1-877-428-2326

Genentech BioOncology Co-Pay Card Program

BioOncology Co-Pay Card Program

If you qualify, the Genentech BioOncology Co–Pay Card Program can help you with the out-of-pocket (OOP) costs of your medicines. The card is for people with a private (commercial) healthcare plan.

Visit www.copayassistancenow.com or call 1-855-MY-COPAY (1-855-692-6729) to learn more about these programs or how to get started.

Additional resources offering financial assistance or information:

CancerCare®
www.cancercare.org

NeedyMeds
www.needymeds.org

Patient Advocate Foundation
www.patientadvocate.org

The Wellness Community®
www.thewellnesscommunity.org

*Disclaimer:
The description of Herceptin® Access Solutions® is provided for informational purposes only. The submission and completion of reimbursement- or coverage-related documentation are the responsibility of the patient and healthcare provider. Genentech, Inc. makes no representation or guarantee concerning reimbursement or coverage for any service or item.

Privacy information: Any information submitted to Herceptin Access Solutions will remain confidential and will not be used for promotional purposes. If you would like to learn more about protecting the privacy of personal health information, please go to the US Department of Health and Human Services website at www.hhs.gov/ocr/privacy.

Herceptin is a registered trademark and the Access Solutions logo and the Access Solutions Treatment made possible logo are trademarks of Genentech, Inc.

Learn more about Herceptin® Access Solutions® and the BioOncology Co-Pay Card Program ›

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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