IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

CETUXIMAB - INJECTION

(se-TUX-i-mab)

COMMON BRAND NAME(S): Erbitux

WARNING: 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.

USES: 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.

HOW TO USE: 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.