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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 ›

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In This Section:

Metastatic Breast Cancer Treatment

Download questions to ask your doctor

If you have HER2+ metastatic breast cancer, Herceptin may help you keep fighting.

Your doctor may prescribe Herceptin, a treatment approved by the FDA for HER2+ metastatic breast cancer, as:

  • A first-line agent together with Taxol
  • A single agent in patients who have already received one or more
    chemotherapy regimens

Herceptin is a therapy that you may take until your cancer spreads further or your side effects become unmanageable, so staying focused on your treatment is important.

Every person who has HER2+ breast cancer is unique, and no cancer treatment works the same for everyone. Speak to your doctor for more information about treatment with Herceptin.

Metastatic breast cancer is breast cancer that has spread to other parts of the body. First-line metastatic therapy is treatment that is given first or as initial treatment when your cancer has spread to other parts of the body. Herceptin, taken with Taxol, is an approved first-line therapy for HER2+ metastatic breast cancer.

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 HER2+ metastatic breast cancer

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When added to chemotherapy, Herceptin is the only targeted HER2 therapy proven to increase the chance of living longer

In study 5, proven results in patients with metastatic breast cancer

  • Among all patients who received Herceptin plus chemotherapy* who were not previously treated for HER2+ metastatic breast cancer, regardless of chemotherapy used (first-line treatment):

60% more

60% increase in median† time to disease progression‡ in the group of patients (n=235) who received Herceptin plus chemotherapy compared with the group of patients (n=234) who received chemotherapy alone
(7.2 months versus 4.5 months)1

24% more

24% increase in median survival in the group of patients (n=235) who received Herceptin plus chemotherapy compared with the group of patients (n=234) who received chemotherapy alone (25.1 months versus 20.3 months)1

Studies 5 & 6 (N=691):

  • 7% of patients experienced congestive heart failure (CHF) on Herceptin as a single agent vs 1% of patients on paclitaxel

  • 11% of patients experienced CHF on Herceptin plus paclitaxel vs 28% of patients on Herceptin plus anthracycline (doxorubicin or epirubicin) and cyclophosphamide vs 7% of patients on anthracycline (doxorubicin or epirubicin) and cyclophosphamide alone

* Chemotherapy was Adriamycin® (doxorubicin) plus Cytoxan® (cyclophosphamide), Ellence® (epirubicin) plus Cytoxan, or Taxol alone.
† Median is the center or middle number when all the data are arranged in increasing order, which in this case means that half of the women had a longer time to disease progression and the other half had a shorter time to disease progression.
‡ Time to progression is the time it takes for the tumor to grow or spread.

Adriamycin is a registered trademark of Pharmacia Inc.
Cytoxan is a registered trademark of Bristol-Myers Squibb Company.
Ellence is a registered trademark of Pfizer Inc.

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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Stay focused on your treatment goals by following your Herceptin therapy as recommended by your doctor

  • Herceptin is usually given at your doctor’s office or clinic
  • Herceptin is given by an IV (intravenous) infusion, which means that it is given through a needle inserted into your vein
  • You will most likely continue to take Herceptin until your disease grows or spreads, or until the side effects become unmanageable

Herceptin infusion times1

First dose 90 minutes
All other doses when taking Herceptin weekly 30 minutes

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
  • The most common side effects associated with Herceptin in the metastatic breast cancer setting are:
    • 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. 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.

Do women on Herceptin experience heart problems?

  • 11% of patients experienced heart problems on Herceptin plus paclitaxel vs 1% paclitaxel alone
  • 28% of patients experienced heart problems on Herceptin plus anthracycline (doxorubicin or epirubicin) (AC) and cyclophosphamide vs 7% of anthracycline (doxorubicin or epirubicin) (AC) alone
  • 7% of patients experienced heart problems on Herceptin as a single agent
  • In 1 pivotal clinical trial in the metastatic setting, 75% of patients with cardiac dysfunction responded to appropriate medical therapy1
  • In the pivotal trial (N=469), of the 63 patients who had cardiac dysfunction, 44 received standard medical treatment; the condition improved with treatment in 33 of the 44 patients, did not change in 5 patients, and worsened in 4 patients1
  • One patient each died in the Herceptin plus CT and CT-alone arms1
References
  1. Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001;344:783-792.
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