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).
Herceptin has 2 approved uses in metastatic breast 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?
- 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
- Herceptin can cause serious heart problems, including:
- A decline in heart function
- Irregular heartbeats
- High blood pressure
- Serious heart attack
- 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.
- 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
- 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
- Lung problems
- Swelling of the lungs
- Severe shortness of breath
- Infusion reaction symptoms consist of:
- Fever and chills
- Pain (in some cases at tumor sites)
- Shortness of breath
- Very low blood pressure
- Lack of energy and strength
- 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 the MotHER Pregnancy Registry by calling 1 (800) 690-6720.
Taking Herceptin Can Result in Serious and Potentially Deadly Lung Problems,
- 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.
- 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
- Feeling tired
- Low red blood cell counts
- Swelling of the mouth lining
- Weight loss
- Upper respiratory tract infections
- Low platelet counts
- Swelling of the mucous membranes
- Swelling of the nose and throat
- Change in taste
- Infusion reactions
- Increased cough
- Feeling tired
- Shortness of breath
- 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
- Swelling of the ankles/legs
- Swelling of the face
- 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 the MotHER
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.
You may report side effects to the FDA at 1 (800) FDA-1088 or www.fda.gov/medwatch. You
may also report side effects to Genentech at
1 (888) 835-2555.
Please see full Prescribing Information for Serious Side Effects and
additional important safety information.