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Erbitux

Erbitux

cetuximab

Manufacturer:

Merck

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Cetuximab
Indications/Uses
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. In combination w/ encorafenib for adult patients w/ metastatic CRC w/ BRAF V600E mutation, who have received prior systemic therapy. Squamous cell cancer of the head & neck in combination w/ RT for locally advanced disease; w/ platinum-based chemotherapy for recurrent &/or metastatic disease.
Dosage/Direction for Use
IV Wkly dose regimen: Initially 400 mg/m2 once a wk to be infused for 120 min. Subsequently, 250 mg/m2 wkly to be infused for 60 min. Max infusion rate: 10 mg/min. Biweekly dose regimen: 500 mg/m2 to be infused for 120 mins once every other wk. Premed: Administer antihistamine & corticosteroid at least 1 hr prior to therapy.
Contraindications
Hypersensitivity. In combination w/ oxaliplatin-containing chemotherapy for patients w/ mutant RAS metastatic CRC or for whom RAS metastatic CRC status is unknown. Consider concomitant use w/ chemotherapeutic agents or RT before initiation of combination treatment.
Special Precautions
Increased risk for anaphylactic reactions in patients w/ a history of allergy to red meat, tick bites or +ve test results for IgE Ab against cetuximab (α-1-3-galactose). Monitor for infusion-related (including anaphylactic) reactions especially in patients w/ reduced performance status & pre-existing cardiopulmonary disease. Possible late-onset infusion-related reactions. Possible ILD (majority in Japanese population); closely 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. Possible severe skin reactions. Determine serum electrolyte levels prior to & periodically during treatment; electrolyte repletion is recommended. Increased risk of severe neutropenia in patients who receive a combination therapy w/ platinum-based chemotherapy. Possible increased frequency of severe & sometimes fatal CV events. 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 or for whom RAS tumour status is unknown. Patients w/ metastatic CRC must undergo a validated test to confirm BRAF V600E mutation prior to combination treatment w/ encorafenib; not to be used in combination w/ encorafenib in patients w/ other than BRAF V600E mutated CRC or for whom BRAF V600E mutation status is unknown. Patients presenting w/ Hb <9 g/dL; leukocyte count <3,000/mm3; ANC <1,500/mm3; platelet count <100,000/mm3. Renal & hepatic impairment. Patients may experience treatment-related symptoms affecting ability to concentrate & react; advise not to drive or use machines until the effect subsides. Pregnancy. Do not breast-feed during treatment & for 2 mth after the last dose. Childn <18 yr.
Adverse Reactions
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; SJS, TEN.
Drug Interactions
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.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01FE01 - cetuximab ; Belongs to the class of EGFR (Epidermal Growth Factor Receptor) inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Erbitux soln for infusion 5 mg/mL
Packing/Price
20 mL x 1's;100 mL x 1's
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