Zuellig Pharma
Concise Prescribing Info
Treatment of patients w/ epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer in combination w/ irinotecan-based chemotherapy or continuous infusional 5-FU/folinic acid + oxaliplatin; monotherapy in patients who have failed oxaliplatin- & irinotecan-based therapy & who are intolerant to irinotecan. Treatment of patients w/ squamous cell cancer of the head & neck in combination w/ radiation therapy for locally advanced disease; platinum-based chemotherapy for recurrent &/or metastatic disease.
Dosage/Direction for Use
Administer antihistamine & corticosteroid as premed prior to therapy. Initially 400 mg/m2 BSA once a wk by IV infusion for 120 min. Subsequently 250 mg/m2 wkly by IV infusion for 60 min. Max infusion rate: 10 mg/min.
Hypersensitivity. Patients w/ mutant RAS metastatic colorectal cancer (mCRC) or for whom RAS mCRC status is unknown. Concomitant use of chemotherapeutics or radiation therapy.
Special Precautions
Monitor for infusion-related reactions esp in patients w/ reduced performance status & preexisting cardiopulmonary disease. Interstitial lung disease. Severe skin reactions. Monitor serum Mg & electrolyte levels. Neutropenia & related infectious complications. CV disorders. History of keratitis, ulcerative keratitis or severe dry eye; KRAS-mutated tumour. Renal & hepatic function. May impair ability to drive or operate machinery. Pregnancy & lactation. Childn >18 yr.
Adverse Reactions
Hypomagnesia; increased liver enzyme levels (ASAT, ALAT, AP); skin reactions eg acne-like rash, pruritus, dry skin, desquamation, hypertrichosis, nail disorders (paronychia), skin necrosis; mild to moderate infusion-related reactions, mucositis.
Drug Interactions
Increased severe leukopenia & neutropenia w/ platinum-based chemotherapeutic agents. Increased MI & CHF w/ fluoropyrimidines. Increased severe diarrhoea w/ capecitabine & oxaliplatin.
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
100 mL x 1's;20 mL x 1's
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