Severe (sometimes fatal) infusion reactions have occurred with cetuximab. Seek immediate medical attention if you have difficulty breathing, hoarseness, itching, or dizziness, as your treatment should be stopped.

Rare deaths (due to heart attack, sudden death) have occurred in patients with head and neck cancer treated with radiation therapy and cetuximab. This may rarely occur days to a few months after the last dose of this medication. Tell your doctor if you have heart disease (e.g., coronary artery disease, congestive heart failure, arrhythmias). Blood levels of certain minerals should be checked often (see Notes section). Seek immediate medical attention if you develop: chest pain, unexplained jaw/left arm pain.

Cetuximab is used alone or with other anti-cancer drugs to treat colorectal cancer that has spread to other parts of the body. These patients generally cannot tolerate or have not responded to another drug called irinotecan. This medication is also used to treat head and neck cancer. Cetuximab works by slowing cancer cell growth. This action occurs when this drug binds to a specific protein (epidermal growth factor receptor-EGFR) on the cancer cells. Cetuximab is a man-made protein (monoclonal antibody).

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Cetuximab may also be used for kidney cancer.

Cetuximab is given by injection into a vein usually once a week by a healthcare professional. Another drug (e.g., diphenhydramine) may be given before you receive cetuximab to lessen the chance of certain side effects. The first dose (loading dose) is larger and is given over 2 hours. All other doses (maintenance doses) are smaller and are given over 1 hour if tolerated. The dosage is based on your medical condition and response to treatment.

A healthcare professional should watch you for at least 1 hour after your infusion is finished to make sure you do not have an infusion reaction. (See Warning section). If you experience a severe infusion reaction, your infusion will be stopped and your doctor may decide to stop further treatments.

(see also Warning section)

Nausea, vomiting, constipation, diarrhea, headache, stomachache, backache, fever/chills, trouble sleeping, weight loss, fatigue, drowsiness, eye redness/itching, nail changes, and dry skin may occur. Nausea and vomiting can be quite severe. In some cases, drug therapy may be necessary to prevent or relieve nausea and vomiting. Not eating before your treatment may help relieve vomiting. Changes in diet such as eating several small meals or limiting activity may help lessen some of these effects. If these effects persist or worsen, notify your doctor or pharmacist promptly.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

An acne-like rash may occur. Depending on how severe this rash is, your doctor may delay your cetuximab treatment, lower your dose, treat the rash with antibiotics, or stop treatment with cetuximab to decrease this potentially serious side effect.

Tell your doctor immediately if any of these unlikely but serious side effects occur: confusion, depression, swelling of hands/feet/lower legs, dehydration, serious infection (e.g., high fever, chills, persistent sore throat), change in amount of urine, severe dizziness, fast/slow/irregular heartbeat.

Rarely, very serious lung problems may occur. Seek immediate medical attention if you develop: trouble breathing.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before receiving cetuximab, tell your doctor or pharmacist if you are allergic to it or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: lung disease, radiation therapy, heart disease (e.g., coronary artery disease, congestive heart failure, arrhythmias).

This medication may make you drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Sunlight may worsen any skin reactions that may occur while you are using this drug. Avoid prolonged sun exposure, tanning booths, and sunlamps during treatment and for 2 months after your last treatment with cetuximab. Use a sunscreen and wear protective clothing when outdoors.

This medication may harm an unborn baby. This medication is not recommended for use during pregnancy. Both males and females using this drug must avoid becoming pregnant or causing pregnancy. Therefore, both males and females using this drug must use at least 2 reliable forms of birth control (e.g., condoms, birth control pills) while using this medication and for 6 months after treatment is ended. Consult your doctor for information on reliable birth control. If you or your partner becomes pregnant while using this drug or during the 6 months after the last treatment, tell both of your doctors immediately.

Based on information from related drugs, cetuximab may pass into breast milk. Because of potential harm to the infant, breast-feeding is not recommended while using cetuximab and for 2 months after the end of treatment. Consult your doctor before breast-feeding.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

Medical tests and regular physical exams should be performed to check for side effects. Laboratory tests should be performed before giving cetuximab to check for the EGFR protein on your tumor. Certain laboratory tests (e.g., calcium, magnesium, potassium levels) will be performed from time to time while you are being treated with cetuximab and up to 8 weeks after your last infusion. Consult your doctor for more details. Keep all scheduled medical appointments.

It is important that you receive cetuximab as scheduled by your doctor. If you miss a dose, contact your doctor immediately to obtain a new dosing schedule.

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).

Information last revised June 2010. Copyright(c) 2010 First Databank, Inc.