Erbitux
Erbitux®
(cetuximab) Solution for intravenous use
WARNING: SERIOUS INFUSION REACTIONS and
CARDIOPULMONARY ARREST
Infusion Reactions: Serious infusion reactions occurred with the administration of Erbitux® 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 preservative-free solution containing 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.
Generic Name: Cetuximab
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Cancer
Get the latest treatment options.
Cancer and Exercise
Resting to conserve energy may not be the best remedy for fatigue during radiation therapy. See more WebMD Videos »
Erbitux
Health Resources
2008 Election & Health Care on WebMD. Get Informed.
Updated & New
RxList does not provide medical advice, diagnosis or treatment.