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|Cetuximab

Cetuximab

Cetuximab is used for:

Treating certain types of colorectal cancer in patients who do not adequately respond to or cannot take other therapy. Cetuximab may be used alone or in combination with irinotecan to treat the cancer. Cetuximab is not a cure for colorectal cancer.

Cetuximab is a monoclonal antibody. It works by blocking growth factor, which the body needs for tumor and normal cell growth.

Do NOT use Cetuximab if:

• you are allergic to any ingredient in Cetuximab

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

Before using Cetuximab :

Some medical conditions may interact with Cetuximab . 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
• if you have a lung disease or a respiratory tract infection
• if you are allergic to mouse proteins

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

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cetuximab 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 Cetuximab :

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

• Cetuximab is usually administered as an injection at your doctor"s office, hospital, or clinic. If you are using Cetuximab at home, carefully follow the injection procedures taught to you by your health care provider.
• Do not shake or dilute Cetuximab .
• If Cetuximab contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of Cetuximab , contact your doctor immediately.

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

Important safety information:

• If nausea, vomiting, or loss of appetite occurs, ask your doctor or pharmacist for ways to lessen these effects.
• Cetuximab may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Cetuximab . Use a sunscreen or protective clothing if you must be outside for a prolonged period.
• If you develop any type of skin reaction, contact your doctor. Do not attempt to treat the reaction without first checking with your doctor.
• LAB TESTS, including blood electrolytes, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Cetuximab with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is unknown if Cetuximab can cause harm to the fetus. If you become pregnant while taking Cetuximab , discuss with your doctor the benefits and risks of using Cetuximab during pregnancy. It is unknown if Cetuximab is excreted in breast milk. Do not breast feed while taking Cetuximab and for 60 days following your last dose.

Possible side effects of Cetuximab :

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:

Back pain; constipation; dehydration; diarrhea; eye redness; general body discomfort; hair loss; headache; indigestion; itching; loss of appetite; nail disorder; nausea; pain, swelling, or redness at the injection site; skin disorder; sleeplessness; stomach pain; stomach upset; tiredness; trouble sleeping; vomiting; weakness; weight loss.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne or acne-like skin conditions; chest pain; decrease in the amount of urine; dry skin; fever; hoarseness; increased cough; mental or mood changes; peeling or splitting skin; red, oozing, or draining areas of skin; severe dizziness; significant weight loss; sore throat; sores on your lips or in the mouth; swelling in the hands, legs, or feet; trouble swallowing.

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.

Cetuximab is usually handled and stored by a health care provider. If you are using Cetuximab at home, store Cetuximab as directed by your pharmacist or health care provider. Do not freeze. Store away from heat, moisture, and light. Keep Cetuximab out of the reach of children and away from pets.

General information:

• If you have any questions about Cetuximab , please talk with your doctor, pharmacist, or other health care provider.
• Cetuximab 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 Cetuximab . 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.