Erbitux (Cetuximab) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 9, 2012

Erbitux

Head and Neck Cancer »

What is cancer?

Cancer is a group of many related diseases that begin in cells, the body's basic unit of life. Normally, cells grow and divide to form new cells in an orderly way. They perform their functions for a while, and then they die. Sometimes, however, cells do not die. Instead, they continue to divide and create new cells that the body does not need. The extra cells form a mass of tissue, called a growth or tumor. There are two types of tumors: benign and malignant. Benign tumors are not cancer. They do not invade nearby tissue or spread to other parts of the body. Malignant tumors are cancer. Their growth invades normal structures near the tumor and spreads to other parts of the body. Metastasis is the spread of cancer beyond one location in the body.

What kinds of cancers are considered cancers of the head and neck?

Most head and neck cancers begin in the cells that line the mucosal surfaces in the head and...

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Erbitux

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Erbitux®
(cetuximab)

WARNING

SERIOUS INFUSION REACTIONS and CARDIOPULMONARY ARREST

Infusion Reactions: Serious infusion reactions occurred with the administration of Erbitux (cetuximab) in approximately 3% of patients in clinical trials, with fatal outcome reported in less than 1 in 1000. [See WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS.] Immediately interrupt and permanently discontinue Erbitux infusion for serious infusion reactions. [See WARNINGS AND PRECAUTIONS and DOSAGE AND ADMINISTRATION.]

Cardiopulmonary Arrest: Cardiopulmonary arrest and/or sudden death occurred in 2% of 208 patients with squamous cell carcinoma of the head and neck treated with radiation therapy and Erbitux. Closely monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after Erbitux. [See WARNINGS AND PRECAUTIONS.]

DRUG DESCRIPTION

Erbitux (cetuximab) is a recombinant, human/mouse chimeric monoclonal antibody that binds specifically to the extracellular domain of the human epidermal growth factor receptor (EGFR). Cetuximab is composed of the Fv regions of a murine anti-EGFR antibody with human IgG1 heavy and kappa light chain constant regions and has an approximate molecular weight of 152 kDa. Cetuximab is produced in mammalian (murine myeloma) cell culture.

Erbitux is a sterile, clear, colorless liquid of pH 7.0 to 7.4, which may contain a small amount of easily visible, white, amorphous cetuximab particulates. Erbitux is supplied at a concentration of 2 mg/mL in either 100 mg (50 mL) or 200 mg (100 mL), single-use vials. Cetuximab is formulated in a solution with no preservatives, which contains 8.48 mg/mL sodium chloride, 1.88 mg/mL sodium phosphate dibasic heptahydrate, 0.41 mg/mL sodium phosphate monobasic monohydrate, and Water for Injection, USP.

What are the possible side effects of cetuximab (Erbitux)?

Some people receiving a cetuximab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel short of breath, weak or dizzy, nauseated, itchy, or have wheezing, noisy breathing, or a hoarse voice during the injection.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

...

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What are the precautions when taking cetuximab (Erbitux)?

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...

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Last reviewed on RxList: 11/9/2011
This monograph has been modified to include the generic and brand name in many instances.