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    DEA Class; Rx

    Common Brand Names; Erbitux

    • Antineoplastics, Monoclonal Antibody; 
    • Antineoplastics, EGFR Inhibitor

    Anti-EGFR monoclonal antibody
    Used for EGFR-positive, Ras wild-type, metastatic colorectal cancer (mCRC); BRAF V600E-mutated mCRC; and locally advanced or metastatic head and neck cancer
    Can cause serious infusion reactions and cardiopulmonary arrest; dermatologic toxicities are common

    Indicated for KRAS mutation-negative (wild-type), epidermal growth factor receptor (EGFR)-expressing colorectal cancer (CRC) as determine by FDA-approved tests

    • Indicated in combination with FOLFIRI (irinotecan, fluorouracil, leucovorin) for first-line treatment

    Indicated in combination with irinotecan in patients refractory to irinotecan-based chemotherapy

    Indicated as a single agent in failed oxaliplatin- and irinotecan-based chemotherapy or in patients intolerant to irinotecan

    Indication in combination with encorafenib for metastatic colorectal cancer (CRC) with a BRAF V600E mutation (as determine by FDA-approved test) after prior therapy

    Indicated in combination with radiation therapy for initial treatment of local or regional cancer

    Indicated in combination with platinum-based therapy with 5-FU for first-line treatment of patients with recurrent locoregional disease or metastatic form

    Indicated as monotherapy in patients with recurrent or metastatic carcinoma for whom prior platinum-based therapy failed

    Epithelial ovarian, fallopian tube or primary peritoneal cancer)

    Treatment following resection

    • Fatigue (72-80%)

    • Nausea (53-58%)

    • Arthralgia (33-41%)

    • Diarrhea (38-40%)

    • Headache (26-34%)

    • Hypertension (24-32%)

    • Epistaxis (30-31%)

    • Dyspnea (26-28%)

    • Stomatitis (19-25%)

    • Pain in extremity (19-25%)

    • Muscular weakness (13-15%)

    • Dysarthria (10-12%)


    • Neutropenia, Grade 2-4 (31%)

    • Hypertension, Grade 2-4 (19%)

    • Peripheral sensory neuropathy, Grade 2-4 (18%)

    • Mucosal inflammation, Grade 2-4 (13%)

    • Proteinuria, Grade 2-4 (12%)

    • Infection, Grade 2-4 (11%)

    • Palmar-plantar erythrodysesthesia, Grade 2-4 (11%)


    • Fatigue (82%)

    • Nausea (72%)

    • Thrombocytopenia (58%)

    • Epistaxis (55%)

    • Headache (49%)

    • Hypertension (42%)

    • Diarrhea (38-39%)

    • Decreased appetite (35%)

    • Abdominal pain, stomatitis, vomiting (33%)

    • Hyperglycemia (31%)

    • Dyspnea (30%)

    • Arthralgia (28%)

    • Hypomagnesemia (27%)

    • Cough (26%)

    • Insomnia, back pain (21%)

    Use in colorectal cancer only with confirmed KRAS mutation-negative (wild-type); confirm Ras mutation status in tumor specimens prior to initiating therapy

    Risk of cardiopulmonary arrest and sudden death (see Black Box Warnings); carefully consider use with radiation therapy or platinum-based therapy with fluorouracil in patients with squamous cell carcinoma of the head and neck (SCCHN) with a history of coronary artery disease, congestive heart failure, or arrhythmias; monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after therapy

    Increases risk of electrolyte depletion, especially hypomagnesemia; hypomagnesemia and accompanying electrolyte abnormalities can occur days to months after initiating therapy; monitor patients weekly during treatment for hypomagnesemia; hypomagnesemia of any grade reported in 4% of patients receiving cetuximab, carboplatin, and fluorouracil; monitor patients weekly during and for at least 8 wk following completion of therapy; replete electrolytes as necessary

    Risk of anaphylactic reactions may increase in patients with a history of tick bites, red meat allergy, or in the presence of IgE antibodies directed against galactose-α-1,3-galactose (alpha-gal); consider testing patients for alpha-gal IgE antibodies using FDA-cleared methods prior to initiating therapy; negative results for alpha-gal antibodies do not rule out the risk of severe infusion reactions

    Risk of infusion reactions; monitor patients following infusion; discontinue therapy for serious infusion reactions (see Black Box Warnings); premedicate with a histamine-1 (H1) receptor antagonist; monitor patients for at least 1 hour following each infusion, in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis; in patients requiring treatment for infusion reactions, monitor for more than 1 hr to confirm resolution of the reaction; interrupt the infusion and upon recovery, resume the infusion at a slower rate or permanently discontinue therapy based on severity

    Mucocutaneous adverse reactions may occur; limit sun exposure; wear sunscreen and hats

    Based on findings from animal studies and its mechanism of action, cetuximab can cause fetal harm when administered to pregnant women

    There is no information regarding the presence of drug in human milk, the effects on the breastfed infant, or the effects on milk production


    400 mg/m2 IV for the initial dose then 250 mg/m2 IV once weekly for subsequent doses; OR 500 mg/m2 IV every 2 weeks.


    400 mg/m2 IV for the initial dose then 250 mg/m2 IV once weekly for subsequent doses; OR 500 mg/m2 IV every 2 weeks.


    Safety and efficacy have not been established.


    Safety and efficacy have not been established.


    injectable solution

    • 2mg/mL (50mL, 100mL single use vials)