A Monoclonal Antibody

Indications: Treatment of KRAS mutation-negative (wild-type), EGFR-expressing metastatic colorectal cancer (in combination with FOLFIRI [irinotecan, fluorouracil, and leucovorin] as first-line treatment, in combination with irinotecan [in patients refractory to irinotecan-based chemotherapy], or as a single agent in patients who have failed oxaliplatin and irinotecan based chemotherapy or who are intolerant to irinotecan); treatment of squamous cell cancer of the head and neck (as a single agent for recurrent or metastatic disease after platinum-based chemotherapy failure; in combination with radiation therapy as initial treatment of locally or regionally advanced disease; in combination with platinum and fluorouracil-based chemotherapy as first- line treatment of locoregional or metastatic disease) Note: Cetuximab is not indicated for the treatment of KRAS mutation-positive colorectal cancer.

Cautions: cardiovascular disease, cardiopulmonary disease, pulmonary disease—discontinue if interstitial lung disease; history of, or risk factors for keratitis, ulcerative keratitis (including contact lens use), or severe dry eye.

Contra-indications: RAS mutated colorectal tumours (or if RAS tumour status unknown)

Pregnancy: use only if potential benefit outweighs risk—no information available

Breast-feeding: avoid breast-feeding during and for 2 months after treatment—no information available.

Side Effects: infusion-related reactions including dyspnea, dizziness, chills, fever, and severe (sometimes fatal) hypersensitivity reactions (possibly delayed onset) such as rash, urticaria, bronchospasm, hypotension, hypertension, and shock; nausea, vomiting, diarrhoea, headache, aseptic meningitis, hypomagnesaemia, hypocalcaemia, conjunctivitis, blepharitis, keratitis, skin reactions including acne, pruritus, dry skin, desquamation, hypertrichosis, nail disorders; very rarely Stevens-Johnson syndrome, toxic epidermal necrolysis.

Dose:

Note: Premedicate with an H1 antagonist (eg, diphenhydramine) IV 30-60 minutes prior to the first dose; premedication for subsequent doses is based on clinical judgement.

Colorectal cancer, metastatic, KRAS mutation-negative (wild-type): IV:

Initial loading dose 400 mg/m2 infused over 120 minutes.

Maintenance dose 250 mg/m2 infused over 60 minutes weekly until disease progression or unacceptable toxicity Note: If given in combination with (irinotecan, fluorouracil, and leucovorin), complete cetuximab infusion 1 hour prior to (irinotecan, fluorouracil, and leucovorin).

Head and neck cancer (squamous cell) (IV):

Initial loading dose 400 mg/m2 infused over 120 minutes Maintenance dose 250 mg/m2 infused over 60 minutes weekly.

Note: If given in combination with radiation therapy, administer loading dose 1 week prior to initiation of radiation course; weekly maintenance dose should be completed 1 hour prior to radiation for the duration of radiation therapy (6-7 weeks). If given in combination with chemotherapy, administer loading dose on the day of initiation of platinum and fluorouracil-based chemotherapy, cetuximab infusion should be completed 1 hour prior to initiation of chemotherapy; weekly maintenance dose should be completed 1 hour prior to chemotherapy; continue until disease progression or unacceptable toxicity. Monotherapy weekly doses should be continued until disease progression or unacceptable toxicity.

Colorectal cancer, advanced, biweekly administration (unlabeled dosing) IV: 500 mg/m2 every 2 weeks (initial dose infused over 120 minutes, subsequent doses infused over 60 minutes) in combination with irinotecan non small cell lung cancer (NSCLC), EGFR-expressing, advanced (unlabeled use) IV.

Initial loading dose 400 mg/m2, followed by maintenance dose 250 mg/m2 weekly in combination with cisplatin and vinorelbine for up to 6 cycles, then as monotherapy until disease progression or unacceptable toxicity.

Squamous cell skin cancer, unrespectable (unlabeled use) IV: Initial loading dose 400 mg/m2, followed by maintenance dose 250 mg/m2 weekly until disease progression.