December 4, 2008


By Anonymous User

Class: Biologic agent

Generic Name: Trastuzumab (trass-TOO-zoo-mab)
Trade Name: Herceptin®

How is this drug used? Trastuzumab is FDA approved for the treatment of breast cancer that has spread to local lymph nodes or distant sites in the body and that expresses the human epidermal growth factor receptor 2 (HER2). It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.
What is the mechanism of action? Trastuzumab is classified as a monoclonal antibody. Trastuzumab produces its anti-cancer effects by binding to and disabling a growth stimulatory pathway on cancer cells referred to as the human epidermal growth factor receptor (HER2) pathway.

How is trastuzumab given (administered)? Trastuzumab is administered into a vein (intravenous) and the dose depends on several factors, including the size of the patient, the particular treatment regimen being used and the overall health of the patient.

During the administration of trastuzumab, particularly the initial infusion, patients may experience chills and fever. Medication to decrease the chances of this reaction occurring may be given prior to treatment with trastuzumab. In addition, a more serious allergic reaction to trastuzumab may occur, although it is rare, that causes difficulty breathing, closing of the throat, swelling of facial features, hives, chills, low blood pressure, or lightheadedness. Patients should tell their healthcare professional immediately if they are experiencing any of these symptoms.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with trastuzumab.  Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver.  Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.  Patients will also have their heart function monitored, as trastuzumab is associated with a rare but serious side effect that affects the pumping action of the heart.

What are the common (occur in 30% or more of patients) side effects of treatment with trastuzumab?

• Generalized weakness
• Generalized pain
• Nausea
• Chills/fever during initial administration of drug

What are the less common (occur in 10% to 29% of patients) side effects of treatment with trastuzumab?

• Abdominal pain
• Loss of appetite
• Rash
• Shortness of breath
• Cough
• Headache
• Insomnia
• Dizziness
• Back pain
• Vomiting
• Diarrhea
• Swelling of feet or lower legs
• Flu-like syndrome
• Sore throat
• Infection

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What are the possible late side effects of treatment with trastuzumab? Patients may experience side effects that inhibit proper action of the heart pumping blood. Patients will be monitored for this and should speak with their physician about this potential side effect.

What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• For mouth sores, patients should rinse their mouth three times a day with a salt and soda solution (8 ounces of water mixed with ½ to 1 tsp baking soda and/or ½ to 1 tsp salt) and brush their teeth with a soft toothbrush to help prevent the development of mouth sores.???
•  Eat small meals frequently to help alleviate nausea.

Are there any special precautions patients should be aware of before starting treatment?

• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.

When should patients notify their physician?

• Signs of an allergic reaction - difficulty breathing, closing of the throat, swelling of facial features, hives, fever, chills or lightheadedness
• Shortness of breath, cough
• Chest pain
• Noticeable changes in heart rate or rhythm
• Swelling of feet or lower legs
• Signs of infection (fever, chills, sore throat, cough)

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Copyright © 2010 CancerConnect Last updated 07/10.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.



The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.

Tags: Biological Therapy, Drug Dictionary, T