(se-TUK-see-mab)

Trade name: Erbitux®

Other name: C225

Cetuximab is the generic name for the trade name drug Erbitux®. In some cases, health care professionals may use the trade name Erbitux® or other name C225 when referring to the generic drug name Cetuximab.

Drug type: Cetuximab is an anti-cancer ("anti-neoplastic") targeted therapy. This medication is classified as a "monoclonal antibody" and "Epidermal Growth Factor Receptor (EGFR) Inhibitor." (For more detail, see "How this drug works" section below).

What Cetuximab is used for:

• Metastatic Colorectal Cancer (cancer spread beyond the colon or rectum)
• Squamous Cell Cancer of the Head and Neck
• Non-small Cell Lung Cancer
• Squamous Cell Skin Cancer

Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How Cetuximab is given:

• Cetuximab is given through a vein (intravenous (IV) Infusion).

The amount of cetuximab that you will receive depends on many factors, including your height and weight, your general health or other health problems, and the type of cancer or condition being treated. Your doctor will determine your dose and schedule.

Side effects:

Important things to remember about the side effects of cetuximab:

• Most people may not always experience all of the side effects listed.
• Cetuximab side effects are often predictable in terms of their onset, duration, and severity.
• Cetuximab side effects are usually reversible and will go away after treatment is complete.
• Cetuximab side effects may be quite manageable. There are many options to help minimize or prevent side effects.

The following side effects are common (occurring in greater than 30%) for patients taking cetuximab:

• Skin reactions: In most people, this will present as an acne like rash and will develop within the first 2 weeks of therapy. The rash can last up to 28 days after stopping treatment with cetuximab. Other rash symptoms may include skin peeling, redness, inflammation, and itchy and dry skin. Tell your doctor of any new or worsening rash symptoms, as they can be severe in some patients. This rash should be treatment with topical antibiotics; it is not recommended that corticosteroid creams be used. Sun exposure may make rash symptoms worse; avoid exposure to the sunlight.
• Generalized weakness, fatigue
• Weight loss and poor appetite
• Diarrhea
• Nausea and Vomiting
• Abdominal pain
• Constipation
• Stomatitis (inflammation of the mouth)
• Low magnesium level
• Low blood counts. Your white cells may temporarily decrease (neutropenia). This can put you at increased risk for infection.
• Difficulty breathing
• Cough
• Peripheral Neuropathy Decreased sensation and paresthesia (numbness and tingling of the extremities) may be noted.
• Liver problems (hepatotoxicity and elevated liver enzymes)
• Infection
• Headache
• Nail changes - inflammation of the skin surrounding a fingernail or toenail

These side effects are less common side effects (occurring in about 10-29%) for patients receiving cetuximab:

• Insomnia
• Fever
• Confusion
• Chills
• Anxiety
• Depression
• Dehydration
• Low calcium level
• Low potassium level
• Upset stomach
• Dry mouth
• Bone and joint pain
• Eye irritation
• Infusion reaction

Serious but rare complications of cetuximab therapy:

• Infusion reactions (also referred to as allergic reaction) may be serious in some patients. This reaction can be severe with difficulty breathing, itching, and low blood pressure. Tell your doctor if you are experiencing any chills, difficulty breathing, or feelings of faintness. Pre-medication will be given prior to infusion as a precaution.
• Cetuximab can cause an increased risk of heart attack. Your doctor will monitor your heart function during and after cetuximab treatment. Tell your doctor if you have a history of coronary artery disease, heart failure, or an abnormal heart rhythm.

Not all side effects are listed above. Some that are rare (occurring in less than 10% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.

When to contact your doctor or health care provider:

Seek emergency help immediately, day or night, if you should experience any of the following symptoms:

• Shortness of breath, wheezing, difficulty breathing, closing up of the throat, swelling of facial features, hives (possible allergic reaction).
• Fever of 100.4˚ F (38˚ C) or higher, chills (possible sign of infection).
• Chest pain or any abnormal feeling of the heart or severe dizziness and fainting.

The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:

• Nausea (interferes with ability to eat and unrelieved with prescribed medication).
• Vomiting (vomiting more than 4-5 times in a 24 hour period).
• Diarrhea (4-6 episodes in a 24-hour period).
• Extreme fatigue (unable to carry on self-care activities).
• Mouth sores (painful redness, swelling or ulcers).
• Rash that is worsening with blisters or open wounds.
• Confusion or mood changes
• Constipation unrelieved by laxative use.
• Swelling of the feet or ankles. Sudden weight gain.
• Unable to eat or drink for 24 hours or have signs of dehydration: tiredness, thirst, dry mouth, dark colored urine and a decrease in the amount of urine, or dizziness.

Always inform your health care provider if you experience any unusual symptoms.

Precautions:

• Before starting cetuximab treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.).
• Do not receive any kind of immunization or vaccination without your doctor's approval while taking cetuximab.
• Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category C (use in pregnancy only when benefit to the mother outweighs risk to the fetus).
• For both men and women: Use contraceptives, and do not conceive a child (get pregnant) while taking cetuximab. Barrier methods of contraception, such as condoms, are recommended for up to 6 months after the last dose of Cetuximab. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
• Do not breast feed while taking cetuximab. Do not resume breast feeding until 60 days after the last dose of cetuximab.

Self-care tips:

• Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
• It is important to void (empty your bladder) frequently. Report any pain or burning on urination to your health care provider.
• Keep palms of hands and soles of feet moist using emollients (non-cosmetic moisturizers)
• Wash your hands often.
• You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
• To help treat/prevent mouth sores, use a soft toothbrush, and rinse three times a day with 1/2 to 1 teaspoon of baking soda and/or 1/2 to 1 teaspoon of salt mixed with 8 ounces of water.
• This medication causes little nausea. But if you should experience nausea, take anti-nausea medications as prescribed by your doctor, and eat small frequent meals. Sucking on lozenges and chewing gum may also help.
• Keep your bowels moving. Your health care provider may prescribe a stool softener to help prevent constipation that may be caused by this medicine.
• An acne-like rash is a common side effect of this medication. If you are experiencing this side effect make sure your health care professional is aware, so they can assess the severity and offer suggestions for management.
• Avoid sun exposure. Wear SPF 30 (or higher) sunblock and protective clothing.
• In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
• Get plenty of rest.
• Maintain good nutrition.
• Remain active as you are able. Gentle exercise is encouraged such as a daily walk.
• Acetaminophen or ibuprofen may help relieve discomfort from fever, headache and/or generalized aches and pains. However, be sure to talk with your doctor before taking it.
• If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and testing:

You will be checked regularly by your health care professional while you are taking cetuximab, to monitor side effects and check your response to therapy. Periodic blood work to monitor your complete blood count (CBC), electrolyte levels (magnesium, potassium, calcium) as well as the function of other organs (such as your kidneys and liver) will also be ordered by your doctor.

How Cetuximab Works:

Targeted therapy

Targeted therapy is the result of about 100 years of research dedicated to understanding the differences between cancer cells and normal cells. To date, cancer treatment has focused primarily on killing rapidly dividing cells because one feature of cancer cells is that they divide rapidly. Unfortunately, some of our normal cells divide rapidly too, causing multiple side effects.

Target therapy is about identifying other features of cancer cells. Scientists look for specific differences in the cancer cells from the normal cells. This information is used to create a targeted therapy to attack the cancer cells without damaging the normal cells, thus leading to fewer side effects. Each type of targeted therapy works a little bit differently but all interfere with the ability of the cancer cell to grow, divide, repair and/or communicate with other cells.

There are different types of targeted therapies, defined in three broad categories. Some targeted therapies focus on the internal components and function of the cancer cell. The targeted therapies use small molecules that can get into the cell and disrupt the function of the cells, causing them to die. There are several types of targeted therapy that focus on the inner parts of the cells. Other targeted therapies target receptors that are on the outside of the cell. Therapies that target receptors are also known as monoclonal antibodies. Anti-angiogenesis drugs target the blood vessels that supply oxygen to the cells, ultimately causing the cells to starve.

Researchers agree that targeted therapies are not a placement for traditional therapies. They may best be used in combination with traditional therapies. More research is needed to identify which cancers may be best treated with targeted therapies and to identify additional targets for more types of cancer.

Using Monoclonal Antibodies as Targeted Therapy

Monoclonal antibodies are a relatively new type of "targeted" cancer therapy. Antibodies are part of the immune system. Normally, the body creates antibodies in response to an antigen (such as a germ) entering the body. The antibodies attach to the antigen in order to mark the antigen for destruction by the body's immune system. In the laboratory, scientists analyze specific antigens on the surface of cancer cells (target) to determine a protein to match the antigen. Then, using protein from animals and humans, scientists work to create a special antibody that will attach to the target antigen. An antibody will attach to a matching antigen like a key fits a lock. This technology allows treatment to target specific cells, causing less toxicity to healthy cells. Monoclonal antibody therapy can be done only for cancers in which antigens (and the respective antibodies) have been identified.

Cetuximab is a targeted therapy that targets and binds to the epidermal growth factor receptors (EGFR).

EGFR is found on the surface of many normal cells and cancer cells.

EGFR, when activated by your body during normal human cell-reproduction, makes the cell grow and divide. However, if the cell is a cancer cell, then growing and dividing means the cancer is getting larger.

By binding to EGFR on cancer cell, cetuximab blocks EGF from binding to this receptor (activation). This stops the cell from continuing the pathway that promotes cell division and growth, effectively stopping the cancer by stopping the cancerous cells from growing and multiplying.

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

Cetuximab. Lexi-comp Online® [May 3, 2016]. Lexi-Drugs. Hudson, Ohio; Lexi-Comp, Inc.; June 29th, 2016.

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