Cetuximab is used to treat cancers of the colon and rectum. It is also used to treat head and neck cancer.

Cetuximab may also be used for purposes not listed in this medication guide.

Cetuximab has caused life-threatening side effects in a small number of patients. Your caregivers will watch you closely after you receive each dose of cetuximab.

Side effects may occur when this medicine is injected into your vein. Tell your caregiver right away if you feel dizzy, feverish, itchy, or short of breath during the infusion.

Cetuximab can have long-lasting effects on your body. You may need frequent medical tests for at least 8 weeks after your last dose.

Cetuximab is given as an infusion into a vein. A healthcare provider will give you this injection.

cetuximab must be given slowly, and the infusion can take up to 2 hours to complete. You may be given other medications to help prevent serious side effects or allergic reaction.

Cetuximab is often used in combination with other cancer medications and/or radiation treatments. You may receive another cancer medicine 1 hour after your cetuximab infusion.

Cetuximab has caused life-threatening side effects in a small number of patients. After each cetuximab infusion, your caregivers will watch you closely to make sure you do not have any serious side effects.

Cetuximab is usually given until your body no longer responds to the medication. Follow your doctor's dosing instructions very carefully.

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results.

Cetuximab can have long-lasting effects on your body. You may need medical tests for at least 8 weeks after your last dose.

You should not use this medicine if you are allergic to cetuximab or to mouse protein.

Tell your doctor if you have ever had:

• heart rhythm problems;

• lung disease or a breathing disorder;

• congestive heart failure;

• coronary artery disease (clogged arteries); or

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).

Tell your doctor if you are allergic to red meat, or if you've ever been bitten by a tick. If so, you may be more likely to have certain reactions during or shortly after injection of this medicine.

Cetuximab may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 2 months after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while using this medicine, and for at least 2 months after your last dose.

Call your doctor for instructions if you miss an appointment for your cetuximab infusion.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Cetuximab could make you sunburn more easily. Avoid sunlight or tanning beds while you are receiving cetuximab and for at least 2 months after your treatment ends. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Some side effects may occur during the infusion or several hours afterward. Tell your caregiver right away if you feel short of breath, itchy, nauseated, weak or dizzy, or if you have chest pain, wheezing, noisy breathing, or a hoarse voice.

Cetuximab may cause serious side effects. Call your doctor at once if you have:

• eye pain or redness, puffy eyelids, drainage or crusting in your eyes, vision problems, or increased sensitivity to light;

• a new or worsening cough, chest pain, or shortness of breath;

• an acne-like skin rash or any severe skin rash;

• redness or crusting around your hair follicles;

• redness, warmth, or puffiness under your skin;

• slow heartbeats, weak pulse, fainting, slow breathing (breathing may stop);

• blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;

• low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing; or

• signs of an electrolyte imbalance--increased thirst or urination, constipation, muscle pain or weakness, leg cramps, numbness or tingling, feeling jittery, irregular heartbeats, fluttering in your chest, or a choking feeling.

Common side effects of cetuximab may include:

• itching or rash;

• changes in your fingernails or toenails;

• dry, cracked, or swollen skin;

• headache;

• diarrhea; or

• infection.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect cetuximab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.