Erbitux

Cetuximab

Patients w/ epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic CRC in combination w/ irinotecan-based chemotherapy or continuous infusional 5-fluorouracil/folinic acid + oxaliplatin; single agent in patients who have failed oxaliplatin- & irinotecan-based therapy & who are intolerant to irinotecan. Patients w/ squamous cell cancer of the head & neck in combination w/ RT for locally advanced disease; platinum-based chemotherapy for recurrent &/or metastatic disease.

IV Administer antihistamine & corticosteroid as premed at least 1 hr prior to therapy. Initially 400 mg/m² BSA once a wk to be infused for 120 min. Subsequently 250 mg/m² BSA wkly to be infused for 60 min. Max infusion rate: 10 mg/min.

Hypersensitivity. Patients w/ mutant RAS metastatic CRC (mCRC) or for whom RAS mCRC status is unknown. Concomitant use w/ chemotherapeutic agents or RT.

Monitor for infusion-related (including anaphylactic) reactions especially in patients w/ reduced performance status & pre-existing cardiopulmonary disease. Possible late-onset infusion-related reactions. Increased risk for anaphylactic reactions in patients w/ a history of allergy to red meat or tick bites or +ve test results for IgE Ab (α-1-3-galactose). ILD (majority in Japanese population); monitor patients w/ confounding or contributing factors eg, concomitant chemotherapy known to be associated w/ ILD & pre-existing pulmonary diseases. Discontinue use if ILD is diagnosed. Severe skin reactions. Determine serum electrolyte levels prior to & periodically during treatment. Increased risk of severe neutropenia in patients in a combination therapy w/ platinum-based chemotherapy. CV disorders. Concomitant administration of cardiotoxic compd (eg, fluoropyrimidines). History of keratitis, ulcerative keratitis or severe dry eye. Not to be used for CRC patients w/ RAS mutated tumours. Patients presenting w/ haemoglobin <9 g/dL; leukocyte count <3,000/mm³; absolute neutrophil count <1,500/mm³; platelet count <100,000/mm³. Renal & hepatic impairment. May impair ability to drive or operate machinery. Pregnancy. Do not breast-feed during treatment & for 2 mth after the last dose. Childn <18 yr.

Hypomagnesaemia; increased liver enzyme levels (AST, ALT, alkaline phosphatase); skin reactions eg, acne-like rash, pruritus, dry skin, desquamation, hypertrichosis, nail disorders (eg, paronychia), skin necrosis; mild or moderate infusion-related reactions, mucositis. Dehydration, hypocalcaemia, anorexia; headache; conjunctivitis; diarrhoea, nausea, vomiting; severe infusion-related reactions, fatigue. ILD; Stevens-Johnson syndrome, TEN.

May increase frequency of severe leukopenia or neutropenia w/ platinum-based chemotherapy. Increased frequency of cardiac ischaemia including MI, CHF & hand-foot syndrome (palmar-plantar erythrodysaesthesia) w/ fluoropyrimidines. May increase frequency of severe diarrhoea w/ capecitabine & oxaliplatin.

Targeted Cancer Therapy

L01FE01 - cetuximab ; Belongs to the class of EGFR (Epidermal Growth Factor Receptor) inhibitors. Used in the treatment of cancer.

POM