Continue the Fight
with Herceptin Therapy

Learn more about the benefits and risks associated with Herceptin therapy.

Adjuvant Breast Cancer Treatment

In 4 trials of more than 10,000 women with early-stage breast cancer

Based on clinical studies, Herceptin demonstrated significant benefits when administered for 1 full year1

It is recommended that Herceptin be taken for 1 year unless your side effects become unmanageable.

Herceptin is given as an IV infusion, and there are 3 ways you can be treated. Your doctor will decide which treatment option is best for you.

  • ACTH: Herceptin is taken as part of a treatment course including the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel.
  • TCH: Herceptin is taken along with the chemotherapy drugs docetaxel and carboplatin.
  • Monotherapy: Herceptin is taken alone after treatment with several other therapies, including an anthracycline (doxorubicin)-based therapy (a type of chemotherapy).

The available dosing options are:

  • With chemotherapy: When you are taking Herceptin together with chemotherapy, you will receive Herceptin once a week
  • After chemotherapy: When you are taking Herceptin after surgery and completion of chemotherapy, you may receive Herceptin either every 3 weeks OR once a week. Your doctor will determine whether weekly treatment or treatment every 3 weeks with Herceptin is right for you

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.

Cardiac monitoring

Why is my heart being monitored while I'm on Herceptin?

Herceptin (trastuzumab) can cause heart problems including an inability to pump blood effectively, irregular heartbeats, high blood pressure, disabling heart failure, weakening of the heart muscle, and sudden loss of heart function leading to death. Herceptin may cause reduced heart function even if there are no symptoms.

Before taking your first dose of Herceptin, your doctor should check to see if you have any health conditions that may increase your chance of having serious heart problems. This includes a review of your health history and tests to see how well your heart muscle is working. These tests may include an echocardiogram, which is an ultrasound image of the heart, or a MUGA scan, which takes a moving picture of your heart pumping blood following an injection of a radioactive substance.

In addition, you should be frequently monitored for decreasing heart function during the time you are receiving Herceptin and after your last dose of Herceptin. If you must permanently or temporarily stop Herceptin due to heart problems, you should be monitored more frequently.

Herceptin has only been approved for use in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer.

What has happened to other women after their Herceptin has been stopped due to heart problems?

In one study, of patients receiving ACTH treatment, 16% had to stop Herceptin because of a significant weakening of heart muscle or decreased heart function.

In another study of patients receiving ACTH treatment, 5.7% had to stop Herceptin because of a significant weakening of heart muscle or decreased heart function.

In a study of patients receiving TCH treatment, 2.9% stopped Herceptin because of heart problems.

Of the patients receiving Herceptin alone in the monotherapy study, 2.6% discontinued use of Herceptin.

  • In two adjuvant clinical trials, among the 32 patients with significant heart problems:
    • One died of significantly weakened heart muscle.
    • All others were on heart medication at their last checkup.
    • Approximately half of the surviving patients had heart function that returned to normal while on ongoing heart medications.
  • For patients with Herceptin-related decrease in heart function, the safety of continuing or restarting Herceptin therapy has not been studied.

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.

Reference

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