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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.

Download the full Prescribing Information View full safety information ›

Safety First! Before you start exploring, take the time to read the Important Safety Information. Roll over to read more ›

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Adjuvant Breast Cancer Treatment

If you’ve been diagnosed with HER2+ breast cancer, you want to do all you can to fight it.

Now your doctor has prescribed adjuvant Herceptin therapy for you. Herceptin is an approved adjuvant therapy for HER2+ early-stage breast cancer.

Adjuvant therapy is additional treatment for early breast cancer that is given after the main treatment (usually surgery). Adjuvant therapy for HER2+ breast cancer may include radiation therapy, chemotherapy, hormonal therapy, and/or targeted therapy.

Herceptin is targeted therapy for HER2+ breast cancer1,2

Diagram of How Herceptin May Work

Targeted therapy is different from other types of therapy. Targeted therapy is designed to target cells with specific receptors for treatment. Some targeted therapies such as Herceptin target HER2 receptors, which may help keep the cancer from growing.2,3

Important Safety Information

  • 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 the adjuvant breast cancer setting were:
    • Fever
    • Chills
    • Headache
    • Infection
    • Heart Problems
    • Trouble sleeping
    • Cough
    • Rash
  • 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
References
  1. 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.
  2. Herceptin Prescribing Information. Genentech, Inc. October 29, 2010.
  3. Treatment option overview. National Cancer Institute website.
    http://www.cancer.gov/cancertopics/pdq/treatment/breast/Patient/page5. Accessed November 17, 2010.
In 4 trials of more than 10,000 women with early-stage breast cancer

Based on clinical trials, Herceptin is recommended for 1 year1

Download questions to ask your doctor

It is recommended that Herceptin be taken for 1 year — and there are different dosing schedules:

  • AC→TH: Herceptin is taken as part of a treatment course including the chemotherapy drugs Adriamycin, Cytoxan, and either Taxol or Taxotere

  • TCH: Herceptin is taken along with the chemotherapy drugs Taxotere and Paraplatin (carboplatin)

  • Monotherapy: Herceptin is taken alone after treatment with several other therapies, including an anthracycline (Adriamycin)-based therapy (a type of chemotherapy)

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.

The available dosing options are:

  • Weekly: When you receive Herceptin together with chemotherapy, you will receive Herceptin once a week
  • Every 3 weeks: When you receive Herceptin after you have had surgery and have finished chemotherapy, you will receive Herceptin every 3 weeks

Serious Side Effects: Infusion Reactions and Lung Problems

  • 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
References
  1. Herceptin Prescribing Information. Genentech, Inc. October 29, 2010.

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Adding 1 year of Herceptin to therapy increased the chance of remaining cancer free longer1

Studies 1 & 2:

After completion of chemotherapy (Adriamycin and Cytoxan), Herceptin weekly taken with Taxol weeks 1-12 followed by Herceptin alone weekly

52% more

52% higher chance of remaining cancer free longer in the group of women who received AC→TH* (n=1872) compared with the group that received AC→T (n=1880), when both groups in these 2 studies were looked at

  • 2% of patients on AC→TH experienced congestive heart failure (CHF) vs 0.4% without Herceptin

Study 3:

After surgery and chemotherapy, Herceptin taken every 3 weeks

46% more

46% higher chance of remaining cancer free longer in the group of women who received Herceptin alone† (n=1693) compared with the group that did not receive Herceptin (n=1693)

  • 2% of patients on Herceptin experienced CHF vs 0.3% without Herceptin

* Herceptin as part of a treatment course including the chemotherapy drugs Adriamycin, Cytoxan, and either Taxol or Taxotere. This treatment course is known as "AC→TH."
† Herceptin alone after treatment with several other therapies, including an anthracycline (Adriamycin)-based therapy (a type of chemotherapy).

Serious Side Effects

  • Herceptin treatment can result in heart problems, including those without symptoms (reduced heart function) and those with symptoms (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 adjuvant (early) patient died 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 your 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

Study 4:

After completion of chemotherapy (Adriamycin and Cytoxan), Herceptin weekly taken with Taxotere weeks 1-12 followed by Herceptin alone every 3 weeks

40% more

40% higher chance of remaining cancer free longer in the group of women who received AC→TH* (n=1074) compared with the group that received AC→T (n=1073)

  • 2% of patients on AC→TH experienced CHF vs 0.3% without Herceptin

Study 4:

After surgery, Herceptin weekly taken with Taxotere and carboplatin weeks 1-18 followed by Herceptin alone every 3 weeks

33% more

33% higher chance of remaining cancer free longer in the group of women who received TCH† (n=1075) compared with the group that received AC→T (n=1073)

  • 0.4% of patients on TCH experienced CHF vs 0.3% without Herceptin

* Herceptin as part of a treatment course including the chemotherapy drugs Adriamycin, Cytoxan, and either Taxol or Taxotere. This treatment course is known as "AC→TH."
† Herceptin with Taxotere and carboplatin. This treatment course is known as "TCH."

Serious Side Effect: 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

Serious Side Effect: Heart Monitoring

  • 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 exhibit weakening of the heart muscle or changes in the heart muscle structure
  • If you are taking Herceptin and have stopped treatment temporarily because of significant heart problems, your doctor should monitor your heart health more frequently
References
  1. Herceptin Prescribing Information. Genentech, Inc. October 29, 2010.

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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.

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

  • In one study of patients receiving adjuvant therapy for breast cancer, 16% had to stop Herceptin because of a significant weakening of heart muscle or decreased heart function
  • In another study, 2.6% of patients stopped Herceptin because of heart problems
  • 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
Next step

Download questions to ask your doctor

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 MotHER—the Herceptin 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
  • Fatigue
  • 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
  • Fatigue
  • 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 MotHER—the Herceptin 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.

Please see full Prescribing Information for Serious Side Effects and additional important safety information.


Herceptin

Herceptin

For additional support: Call 866.449.HER2 Chat with Nurse