Erbitux®

Posted on April 28th, 2009 by

Class: Biologic Therapy

Generic Name: Cetuximab
Trade Name: Erbitux™

For which conditions is this drug approved? Cetuximab is FDA approved for the treatment of advanced colorectal cancer. The FDA indication specifies that cetuximab is to be used in combination with irinotecan for the treatment of EGFR-expressing, metastatic colorectal cancer in patients who are refractory to irinotecan-based chemotherapy. Cetuximab is also indicated as a single agent for the treatment of EGFR-expressing, metastatic colorectal cancer in patients who are intolerant to irinotecan-based chemotherapy.

Cetuximab is also FDA approved for the treatment of head and neck cancer. The FDA indication specifies that cetuximab is to be used in combination with radiation therapy for patients with locally or regionally advanced squamous cell head and neck cancer, or to be used as a single agent in the treatment of metastatic or recurrent squamous cell head and neck cancer if the cancer progresses following prior platinum-based chemotherapy.

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? Cetuximab belongs to a class of drugs called monoclonal antibodies. Cetuximab produces its anti-cancer effects by targeting the epidermal growth factor receptor (EGFR). EGFR is a protein found on the surface of some cells that is important for cellular growth, replication and spread. Cetuximab binds to the EGFR and inhibits the growth and survival of tumor cells that over-express the EGFR. Overexpression of EGFR is detectable in many human tumors including those of the colon and rectum. It is also expressed in many normal epithelial tissues including the skin and hair follicle.

How is cetuximab typically given (administered)? Cetuximab is administered intravenously (into a vein) and the dose depends on several factors, including the condition being treated, the size of the patient, the particular regimen being used and the overall health of the patient. Severe infusion reactions may occur during the administration of cetuximab. Patients will be closely monitored during and after infusions.

How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with cetuximab. 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. In addition, patients will be monitored for the development of severe rash and allergic or severe infusion reactions (may include airway obstruction, hoarseness, or low blood pressure).

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

• Generalized fatigue or weakness
• Acneform rash, dry skin
• Diarrhea
• Abdominal Pain
• Nausea
• Vomiting
• Fever
• Constipation

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

• Infusion reaction (fever, chills, difficulty breathing, change in blood pressure)
• Itching
• Infection
• Back pain
• Headache
• Mouth sores
• Lack of appetite
• Low white blood cell levels (increase risk of infection)
• Low red blood cell levels (increased risk of anemia)
• Increased cough
• Weight loss
• Swelling of extremities
• Insomnia
• Nail disorder with swelling of the lateral nail folds of the fingers and toes

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.
• 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.)
• If possible, avoid large crowds or people who are sick or not feeling well, as this drug may leave some patients susceptible to infection.
• Eat small meals frequently to help alleviate nausea.
• 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.

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?

• Rash
• Fever, chills, cough, sore throat, flu or cold-like symptoms
• Persistent or severe fatigue
• Signs of infection – redness, swelling, pus, tenderness
• Mouth sores
• Extreme or persistent nausea and vomiting
• Persistent diarrhea
• Acute onset or worsening pulmonary symptoms

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 of clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug.Click here to view the package insert

Copyright © 2005 Cancer Consultants Last updated 01/05.


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Tags: Biological Therapy, E

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