Why Herceptin
May Be Right for You

Learn more about the benefits and risks associated with Herceptin therapy in HER2+ metastatic stomach or gastroesophageal junction (GEJ) cancer.

HER2+ Metastatic Stomach/GEJ Cancer Treatment

Herceptin is targeted therapy for HER2+ metastatic stomach/GEJ cancer

Herceptin is a monoclonal antibody — a type of targeted therapy — shown in preclinical studies to target cells with too many HER2 receptors.1

Herceptin is the first and only targeted therapy approved for the treatment of first-line HER2+ metastatic stomach or GEJ cancer. Traditional therapies, such as chemotherapy and radiation therapy, are also used to treat HER2+ metastatic stomach or GEJ cancer.

Targeted therapy is different from other types of therapy. Targeted therapy is a type of medicine that is designed to attack specific cancer cells and can affect healthy cells.

How Herceptin may work1,2

how Herceptin may work

Normal cells also have HER2 (just not as much), so HER2-targeted therapies can also affect normal cells and can cause side effects, including serious side effects.

Serious Side Effects

Be sure to contact your doctor if you:


Are a woman who could become pregnant, or may be pregnant

iHERCEPTIN may result in the death of an unborn baby or birth defects. Contraception should be used while receiving HERCEPTIN and after your last dose of HERCEPTIN. If you are exposed to HERCEPTIN during pregnancy or within 7 months of becoming pregnant, you are encouraged to enroll in the MotHER Pregnancy Registry by contacting 1-800-690-6720 or visiting http://www.motherpregnancyregistry.com/ and report HERCEPTIN exposure to Genentech at 1-888-835-2555.

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.

In first-line HER2+ metastatic stomach/GEJ cancer

Herceptin is the first and only first-line monoclonal antibody proven to increase the chance of living longer

In a clinical study, ToGA, of 594 patients with HER2+ metastatic stomach/GEJ cancer who were not previously treated, there was a:

23%
23% increase in median overall survival (OS) shown in the final median overall survival analysis.1* (13.5-month median OS with Herceptin and chemotherapy vs 11.0-month median OS with chemotherapy alone.)
12%
12% increase in median OS shown in the updated median overall survival analysis.1ठ(13.1-month median OS with Herceptin and chemotherapy vs 11.7-month median OS with chemotherapy alone.)
*
In the final overall survival analysis, median OS meant half the patients treated with Herceptin plus chemotherapy lived less than 13.5 months, while half lived longer.
Chemotherapy was cisplatin plus either capecitabine or 5-fluorouracil.

In the updated overall survival analysis, median OS meant half the patients treated with Herceptin plus chemotherapy lived less than 13.1 months, while half lived longer.
§
Updated analysis was conducted 1 year after the final analysis.

Serious Side Effects

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.

What are the most common side effects of Herceptin as seen in the ToGA* trial?

5%

5% of patients in the Herceptin plus chemotherapy arm had a side effect where less than half their blood was pumped from the left ventricle with each heartbeat, compared with 1.1% of patients in the chemotherapy alone arm.1

In the ToGA trial, the most common adverse reactions (occurring in ≥10% of patients) that were increased (≥5% difference) with Herceptin plus chemotherapy vs chemotherapy alone were:

  • Low white and red blood cell counts
  • Diarrhea
  • Feeling tired
  • 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

In the ToGA trial, the most common adverse events that led to discontinuation of Herceptin (without worsening of the disease) were:

  • Infection
  • Diarrhea
  • Fever brought on by low white blood cell counts
*
Study that led to the approval of Herceptin in stomach/gastric cancer.

What can I expect when on Herceptin plus chemotherapy?

Herceptin is given as 1 of 2 regimens1

Herceptin + cisplatin + capecitabine
Herceptin + cisplatin + 5-FU*

*Also known by its full name (5-fluorouracil).

  • Herceptin is usually given at your doctor’s office or clinic.
  • Herceptin is given by an IV (intravenous) infusion, which means it is given through a needle that is inserted into your vein.
  • In HER2+ metastatic stomach/GEJ cancer, Herceptin is given every 3 weeks.

Talk to your doctor about your treatment goals

  • You will most likely continue to take Herceptin until your disease grows or spreads or until the side effects become unmanageable.

How is Herceptin given?

Herceptin administration1

First dose90 minutes
All other doses when taking Herceptin every 3 weeks30-90 minutes

Serious Side Effects

Be sure to contact your doctor if you:


Are a woman who could become pregnant, or may be pregnant

HERCEPTIN may result in the death of an unborn baby or birth defects. Contraception should be used while receiving HERCEPTIN and after your last dose of HERCEPTIN. If you are exposed to HERCEPTIN during pregnancy or within 7 months of becoming pregnant, you are encouraged to enroll in the MotHER Pregnancy Registry by contacting 1-800-690-6720 or visiting http://www.motherpregnancyregistry.com/ and report HERCEPTIN exposure to Genentech at 1-888-835-2555.

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. 


Indications

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)

Patients are selected for therapy based on an FDA-approved test for Herceptin

*
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

Patients are selected for therapy based on an FDA-approved test for Herceptin

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.

Patients are selected for therapy based on an FDA-approved test for Herceptin.

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 a woman who could become pregnant, or may be pregnant

HERCEPTIN may result in the death of an unborn baby or birth defects. Contraception should be used while receiving HERCEPTIN and after your last dose of HERCEPTIN. If you are exposed to HERCEPTIN during pregnancy or within 7 months of becoming pregnant, you are encouraged to enroll in the MotHER Pregnancy Registry by contacting 1-800-690-6720 or visiting http://www.motherpregnancyregistry.com/ and report HERCEPTIN exposure to Genentech at 1-888-835-2555.

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.

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 http://www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information, including Boxed WARNINGS.

References

1. Herceptin Prescribing Information. Genentech, Inc. 2017.
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.