Generic
Cetuximab
Indications
Squamous Cell Carcinoma Of The Head And Neck (SCCHN): Cetuximab is indicated in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck. Cetuximab 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. Cetuximab, 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: Cetuximab 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.
Contraindications
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) cetuximab 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.
Side Effects
Dose modification in cases of severe acneiform rash (grade 3 or 4): 1st occurrence: Delay infusion by 1-2 wk. If improvement, continue at 250 mg/m2; discontinue if no improvement. 2nd occurrence: Delay infusion by1-2 wk. If improvement, continue at reduced dose of 200 mg/m2; discontinue if no improvement. 3rd occurrence: Delay infusion by 1-2 wk. If improvement, continue at reduced dose of 150 mg/m2; discontinue if no improvement. 4th occurrence: Discontinue therapy.
Pregnancy And Lactation
The maximum single dose of cetuximab administered is 1000 mg/m2 in one patient. No adverse events were reported for this patient.
Therapeutic
Targeted Cancer Therapy
Storage Conditions
Store vials under refrigeration at 2� to 8� C. Do not freeze.
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