Herceptin®

Posted on December 2nd, 2008 by

Class: Biologic agent

Generic Name: Trastuzumab (trass-TOO-zoo-mab)

Trade Name: Herceptin®

How is this drug used? Herceptin is FDA approved for the treatment of the following cancers if they test positive for a protein known as HER2: breast cancer that has spread to the lymph nodes; node-negative breast cancer that is estrogen receptor-negative or has a high-risk feature; metastatic breast cancer (breast cancer that has spread to other parts of the body); and metastatic cancer of the stomach or gastroesophageal junction (where the esophagus joins the stomach). 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? Herceptin is classified as a monoclonal antibody. Herceptin 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 2 (HER2) pathway.

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

During the administration of Herceptin, 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 Herceptin. In addition, a more serious allergic reaction to Herceptin 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 Herceptin.  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 Herceptin is associated with a rare but serious side effect that affects the pumping action of the heart.

What are the common side effects of Herceptin among patients with early-stage breast cancer?

  • Headache
  • Diarrhea
  • Nausea
  • Chills

What are the common side effects of Herceptin among patients with metastatic breast cancer?

  • Fever
  • Chills
  • Headache
  • Infection
  • Congestive heart failure
  • Insomnia
  • Cough
  • Rash

What are the common side effects of Herceptin among patients with metastatic stomach cancer?

  • Low blood cell counts (white blood cells, red blood cells, and platelets)
  • Diarrhea
  • Fatigue
  • Inflammation of the lining of the mouth (stomatitis)
  • Weight loss
  • Upper respiratory tract infections
  • Fever
  • Change in taste

What are the less common but potentially serious side effects of Herceptin?

  • Heart problems
  • Severe infusion reactions or lung problems

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 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.
  • 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 effective birth control while undergoing treatment.
  • It is important that patients inform their physician of any pre-existing conditions, including heart problems.
  • 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?

Tell your doctor if you experience any side effects that bother you or don’t go away. Also tell your doctor if you experience any of the following:

  • New or worsening shortness of breath
  • Cough
  • Swelling of the ankles, legs, or face
  • Palpitations
  • Weight gain of more than five pounds in 24 hours
  • Dizziness or loss of consciousness

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.

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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.

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Tags: Biological Therapy, H

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