Zuellig Pharma
Concise Prescribing Info
Epidermal growth factor receptor (EGFR) expressing RAS wild-type metastatic colorectal cancer in combination w/ irinotecan-based chemotherapy, in 1st-line combination w/ FOLFOX, as single agent after failure of oxaliplatin- & irinotecan-based therapy & for patients' intolerant to irinotecan. Squamous cell head & neck cancer in combination w/ radiation therapy for locally advanced disease & in combination w/ platinum-based chemotherapy for recurrent &/or metastatic disease.
Dosage/Direction for Use
1-hr prior to 1st infusion, patient must receive premed w/ antihistamine & corticosteroid. Initially 400 mg/m2 once wkly. Max infusion rate: 5 mg/min for120 min. Subsequent wkly dose: 250 mg/m2 once wkly. Max infusion rate: 10 mg/min for 60 min. IV administered w/ infusion pump, gravity dip or syringe pump.
Hypersensitivity. Combination w/ oxaliplatin-containing chemotherapy in patients w/ mutant RAS metastatic colorectal cancer or unknown cancer status. Concomitant use of chemotherapeutic agents or radiation therapy.
Special Precautions
Severe infusion-related reactions including anaphylactic reactions; history of allergy to red meat or tick bites or +ve IgE Ab test results. Discontinue use if interstitial lung disease (ILD) is diagnosed. Temporary interruption if severe skin reactions occur. Not be used for colorectal cancer patients whose tumours have RAS mutations or unknown status. Patients w/ reduced performance status, preexisting cardiopulmonary diseases & haematological disorders; neutropenia & related infectious complications; CV status; history of keratitis, ulcerative keratitis or severe dry eye. Patients w/ confounding or contributing factors eg, concomitant chemotherapy associated w/ ILD & preexisting pulmonary diseases. Determine serum electrolyte levels prior to & periodically thereafter. Concomitant use w/ cardiotoxic compd eg, fluoropyrimidines; combination w/ radiation therapy in colorectal cancer. Contact lens users. May affect ability to drive & use machines. Hepatic & renal impairment. Pregnancy. Not recommended during lactation. Childn <18 yr. Elderly ≥75 yr.
Adverse Reactions
Skin reactions; hypomagnesaemia; increased liver enzyme levels; mild or moderate infusion-related reactions, mucositis. Dehydration, hypocalcaemia, anorexia; headache; conjunctivitis; diarrhoea, nausea, vomiting; severe infusion-related reactions, fatigue.
Drug Interactions
Increased frequency of severe leukopenia or neutropenia w/ platinum-based chemotherapy. Increased frequency of cardiac ischaemia w/ fluoropyrimidines. Increased frequency of severe diarrhoea w/ capecitabine & oxaliplatin.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01XC06 - cetuximab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Erbitux infusion 5 mg/mL
20 mL x 1's
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