Important Safety Information  |  Go to Healthcare Professionals Site ›

close

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 ›

Related Links & Downloads

Patient Resources

Breast Cancer Glossary

Common breast cancer terms and their meaning

A-C | D-F | G-I | J-L | M-O | P-R | S-Z

Back to top

A-C

Adjuvant therapy

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, or targeted therapy.

Aggressive cancer

Cancers that grow and spread very quickly. HER2+ breast cancer (sometimes called HER2-overexpressing breast cancer) is considered aggressive because the cells have too many HER2 receptors, causing the cells to grow and divide too quickly.

Anthracycline

A type of chemotherapy drug (eg, Adriamycin) that stops the growth of cells and makes it difficult for cells to repair damage.

Axillary lymph nodes

Lymph nodes found in the armpit area. These may be removed and tested for cancer cells during surgery.

Biopsy

The removal of cells or tissue to check under a microscope.

Chemotherapy

Drugs that are used to destroy cells.

CISH (chromogenic in situ hybridization)

A method of testing tissue samples.

Congestive heart failure (CHF)

When the heart cannot pump blood effectively; this can lead to a buildup of fluid in the body.

Back to top

D-F

Echocardiogram (ECHO)

An ultrasound image of the heart.

First-line metastatic therapy

Treatment that is given first or as initial treatment when your cancer has spread to other parts of the body.

FISH (fluorescence in situ hybridization)

A method of testing tissue samples.

Back to top

G-I

HER2 (Human Epidermal growth factor Receptor 2)

A receptor on the surface of cells that causes cells to grow and divide. Having too many HER2 receptors (known as HER2+) can cause cancer cells to grow and divide too quickly.

Hormonal therapy

Hormonal therapy helps fight tumors that thrive on hormones like estrogen or progesterone by acting on hormone receptors on tumor cells or by decreasing the amount of estrogen available to bind these receptors.

IHC (immunohistochemistry)

A method of testing tissue samples.

IV (intravenous)

A method of administering a drug by inserting a needle into your vein. Also known as infusion.

Back to top

J-L

Lumpectomy

A type of surgery for breast cancer that involves removing the lump and some surrounding tissue.

Back to top

M-O

Malignant

Another word for cancerous.

Mammogram

An X-ray of the breast done with a specially developed machine that helps detect lumps or abnormalities. Annual screening mammograms are recommended for women age 40 and over.

Mastectomy

A type of surgery for breast cancer that involves removing the entire breast.

Median

The center or middle number when all the data are arranged in increasing order.

Metastatic breast cancer

Breast cancer that has spread to other parts of the body.

MUGA scan (multigated acquisition scan)

Takes a moving picture of the heart pumping blood following an injection of a radioactive substance.

Neutropenia

A common side effect in patients being treated for cancer. This means that your white blood cell count is low.

Back to top

P-R

Pathology report

A report that details the results of a tissue exam conducted to determine the presence of disease. The pathology report can help a doctor determine how advanced the cancer is, how aggressive it is, and other unique characteristics that will help in making better treatment decisions.

Radiation therapy

Radiation therapy uses high-energy rays to kill cells and/or shrink tumors.

Back to top

S-Z

Stages

Cancer is ranked in stages depending on size and whether the cancer has spread to lymph nodes or other parts of the body. Breast cancer is ranked from stage a to stage 4. Knowing the stage helps your doctor plan the best treatment for you.

Surgery

A type of cancer treatment that involves removing tumors and/or lymph nodes from the body. This can include a mastectomy or lumpectomy for breast cancer.

Targeted therapy

A type of treatment designed to target cells with specific types of receptors.

Taxane

A type of chemotherapy drug (eg, Taxol, Taxotere) that stops the growth of cells and makes it difficult for cells to repair damage.

Tumor

An abnormal mass of tissue that comes from the overgrowth of cells.

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