Squamous Cell Carcinoma Of The Head And Neck (SCCHN) : Cetuxim is indicated in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck. Cetuxim is indicated in ... Read more Squamous Cell Carcinoma Of The Head And Neck (SCCHN) : Cetuxim is indicated in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck. Cetuxim is indicated in combination with platinum-based therapy with 5-FU for the first-line treatment of patients with recurrent locoregional disease or metastatic squamous cell carcinomaof the head and neck. Cetuxim, as a single agent, is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck for whom prior platinum-based therapy has failed. K-Ras Wild-Type, EGFR-Expressing Colorectal Cancer : Cetuxim is indicated for the treatment of K-Ras wild-type, epidermal growth factor receptor (EGFR)- expressing, metastatic colorectal cancer (mCRC) as determined by FDA-approved tests for this use In combination with FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) for first-line treatment In combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy As a single agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan.
Cetuximab is a recombinant human/mouse chimeric monoclonal antibody. It binds specifically to the epidermal growth factor receptor (EGFR), thus competitively inhibiting the binding of epidermal growth factor (EGF) and other ligands. This blocks phosphorylation and activation of receptor-associated kinases, thus inhibiting cell growth, inducing apoptosis and decreases matrix metalloproteinase and vascular EGF production.
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Squamous Cell Carcinoma Of The Head And Neck: Cetuximab in combination with radiation therapy or in combination with platinum-based therapy with 5-FU : The recommended initial dose is 400 mg/m 2 administered one week prior to initiation of a course of radiation therapy or on the day of initiation of platinum-based therapy with 5-FU as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min). Complete Cetuximab administration 1 hour prior to platinum-based therapy with 5-FU. The recommended subsequent weekly dose (all other infusions) is 250 mg/m 2 infused over 60 minutes (maximum infusion rate 10 mg/min) for the duration of radiation therapy (6–7 weeks) or until disease progression or unacceptable toxicity when administered in combination with platinum-based therapy with 5-FU. Complete Cetuximab administration 1 hour prior to radiation therapy or platinumbased therapy with 5-FU. Cetuximab monotherapy : The recommended initial dose is 400 mg/m 2 administered as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min). The recommended subsequent weekly dose (all other infusions) is 250 mg/m 2 infused over 60 minutes (maximum infusion rate 10 mg/min) until disease progression or unacceptable toxicity. Colorectal Cancer: Determine EGFR-expression status using FDA-approved tests prior to initiating treatment. Also confirm the absence of a Ras mutation prior to initiation of treatment with Cetuximab. The recommended initial dose, either as monotherapy or in combination with irinotecan or FOLFIRI (irinotecan, 5-fluorouracil, leucovorin), is 400 mg/m 2 administered as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min). Complete Cetuximab administration 1 hour prior to FOLFIRI. The recommended subsequent weekly dose, either as monotherapy or in combination with irinotecan or FOLFIRI, is 250 mg/m 2 infused over 60 minutes (maximum infusion rate 10 mg/min) until disease progression or unacceptable toxicity. Complete Cetuximab administration 1 hour prior to FOLFIRI. Recommended Premedication : Premedicate with an H1 antagonist (eg, 50 mg of diphenhydramine) intravenously 30–60 minutes prior to the first dose; premedication should be administered for subsequent Cetuximab doses based upon clinical judgment and presence/severity of prior infusion reactions.
Fatigue, pain, headache, fever, confusion, anxiety, insomnia, chills, rigors, depression. Acneiform rash, rash, dry skin, pruritus, nail changes, hypomagnesaemia, abdominal pain, constipation, diarrhoea, vomiting, nausea, wt loss, weakness, bone pain.
Infusion rate should be reduced if patient exhibits signs of toxicity. Discontinue treatment if there is severe infusion reactions. Caution when used in patients with history of coronary artery disease, heart failure and arrhythmias. Monitor serum electrolytes during and after (for at least 8 wk) Cetuxim therapy. Exposure to sunlight may worsen skin reactions. Risk of interstitial lung disease in patients with preexisting lung disease. Dose should be modified if there is occurrence of severe acneiform rash, refer to product insert/SPG for dosing guidelines.