DrugindexOnline^{2nd edition}

Generic Name: Cetuximab (se-TUX-i-mab)
Brand Name: Erbitux

Serious and sometimes fatal reactions have occurred in patients receiving Erbitux . Many of the reactions have occurred during the first dose. If you develop symptoms such as sudden trouble breathing, hoarseness, hives, itching, severe dizziness, or chest pain or tightness, seek immediate medical attention. The risk of heart attack or sudden death may be increased in patients who receive Erbitux along with radiation to treat certain types of cancer of the head and neck. Be sure to tell your doctor if you have heart blood vessel problems, heart failure, or an irregular heartbeat. Lab tests, including blood electrolytes, may be performed while you use Erbitux and for a period of time after you finish Erbitux .

Erbitux is used for:

Treating certain types of head, neck, and colorectal cancer. This medicine may be used alone or along with radiation treatments or other medicines. It may also be used for other conditions as determined by your doctor.

Erbitux is a monoclonal antibody. It works by blocking a certain growth factor. This helps to reduce the growth and survival of certain types of cancer cells.

Do NOT use Erbitux if:

• you are allergic to any ingredient in Erbitux

Contact your doctor or health care provider right away if any of these apply to you.

Before using Erbitux :

Some medical conditions may interact with Erbitux . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances (eg, mouse protein)
• if you have lung problems (eg, interstitial lung disease, pulmonary fibrosis), breathing problems, or a respiratory tract infection
• if you have a history of blood vessel problems, heart problems, heart failure, or irregular heartbeat
• if you are having radiation therapy or other types of chemotherapy (eg, cisplatin)

Some MEDICINES MAY INTERACT with Erbitux . However, no specific interactions with Erbitux are known at this time.

Ask your health care provider if Erbitux may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Erbitux :

Use Erbitux as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Erbitux is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Erbitux at home, a health care provider will teach you how to use it. Be sure you understand how to use Erbitux . Follow the procedures you are taught when you use a dose. Contact your health chare provider if you have any questions.
• Do not use Erbitux if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Do not shake or dilute Erbitux .
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Erbitux , contact your doctor right away.

Ask your health care provider any questions you may have about how to use Erbitux .

Important safety information:

• This medicine may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Erbitux with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Erbitux may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Erbitux . Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• If nausea, loss of appetite, vomiting, or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions on how to lessen these effects.
• Lab tests, including blood electrolytes, may be performed while you use Erbitux . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Erbitux should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is not known if Erbitux can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Erbitux while you are pregnant. It is not known if Erbitux is found in breast milk. Do not breast-feed while using Erbitux or for 60 days after your last dose.

Possible side effects of Erbitux :

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; changes in fingernails or toenails; constipation; cough; diarrhea; dry mouth; dry skin; eye redness or irritation; general body discomfort; hair loss; headache; indigestion; loss of appetite; nausea; pain, swelling, or redness at the injection site; sleeplessness; stomach pain or upset; tiredness; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breathing problems or shortness of breath; chest pain; confusion; decrease in the amount of urine; fever, chills, or sore throat; hoarseness; mental or mood changes; peeling, redness, cracking, or oozing of the skin; severe dizziness; severe or persistent acne; severe or persistent nausea or vomiting; sores on your lips or in the mouth; swelling of the hands, legs, or feet; trouble swallowing; weight loss.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Proper storage of Erbitux :

Erbitux is usually handled and stored by a health care provider. If you are using Erbitux at home, store Erbitux as directed by your pharmacist or health care provider.

General information:

• If you have any questions about Erbitux , please talk with your doctor, pharmacist, or other health care provider.
• Erbitux is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Erbitux . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.