Cetuximab

DEA Class; Rx

Common Brand Names; Erbitux

• Antineoplastics, Monoclonal Antibody; 
• Antineoplastics, EGFR Inhibitor

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

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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%)

Platinum-resistant

• 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%)

Platinum-sensitive

• 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

Cetuximab

injectable solution

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