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Erbitux

Erbitux

cetuximab

Manufacturer:

PT. Merck Tbk
Concise Prescribing Info
Contents
Cetuximab
Indications/Uses
Epidermal growth factor receptor-expressing RAS wild-type metastatic CRC (mCRC) in combination w/ chemotherapy or in patients who have failed oxaliplatin- & irinotecan-based therapy, & who are intolerant to irinotecan. Squamous cell cancer of the head & neck in combination w/ RT for locally advanced disease or platinum-based chemotherapy for recurrent &/or metastatic disease.
Dosage/Direction for Use
IV infusion Premed: Administer antihistamine & corticosteroid at least 1 hr prior to therapy. Initially 400 mg/m2 in 120-min infusion once wkly. Subsequent wkly doses: 250 mg/m2 for 60 min once wkly. Max infusion rate: 10 mg/min.
Contraindications
Severe hypersensitivity (grade 3 or 4). Combination w/ oxaliplatin-containing chemotherapy in patients w/ mutant RAS metastatic CRC (mCRC) or unknown RAS mCRC status. Consider concomitant use w/ chemotherapeutic agents or RT.
Special Precautions
Severe infusion-related reactions including anaphylactic reactions; history of allergy to red meat or tick bites or +ve IgE Ab test results. Monitor especially in patients w/ reduced performance status & pre-existing cardiopulmonary disease. Discontinue use if ILD is diagnosed. Interrupt treatment in case of severe skin reaction (≥ grade 3). Interrupt or discontinue treatment if ulcerative keratitis is confirmed. Not be used for CRC patients whose tumours have RAS mutations or unknown status. Increased risk of secondary infections & cases of staphylococcal scalded skin syndrome, necrotising fasciitis & sepsis. Electrolyte disturbances. History of keratitis, ulcerative keratitis or severe dry eye. Contact lens use is a risk factor for keratitis & ulceration. Patients presenting w/ Hb <9 g/dL; leukocyte count <3,000/mm3; ANC <1,500/mm3; platelet count <100,000/mm3; w/ pre-existing haematological disorders. Determine serum electrolyte levels prior to & periodically during treatment; electrolyte repletion is recommended. Combination w/ platinum-based chemotherapy increased risk of severe neutropenia which may lead to subsequent infectious complications eg, febrile neutropenia, pneumonia or sepsis. Monitor patients who experience skin lesions, mucositis or diarrhoea. Take into account CV & performance status of the patient & concomitant administration of cardiotoxic compd eg, fluoropyrimidines. Promptly refer to ophthalmology patients w/ signs & symptoms suggestive of keratitis eg, acute or worsening: eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain &/or red eye. May affect ability to drive & use machines. Pregnancy. Do not breast-feed during treatment & for 2 mth after the last dose. Childn <18 yr. Elderly ≥75 yr.
Adverse Reactions
Hypomagnesaemia; increased liver enzyme levels (AST, ALT, alkaline phosphatase); skin reactions; 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
Increased 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
100 mL x 1's;20 mL x 1's (Rp3,850,000/vial)
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