Cetuximab

Registered South African indications:

• Epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer
• Squamous cell cancer of the head and neck

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Patients with mutant RAS metastatic colorectal cancer (mCRC) or for whom RAS mCRC status is unknown
• Before initiation of combination treatment, contraindications for concomitantly used chemotherapeutic agents or radiation therapy must be considered

Cautions

• Pregnancy
• Breastfeeding
• History of allergy to red meat or tick bites or positive results of tests for IgE antibodies against cetuximab
• Reduced performance status 
• Pre-existing cardio-pulmonary disease
• Japanese population
• History of keratitis, ulcerative keratitis or severe dry eye
• Concomitant use of contact lenses
• Treatment of colorectal cancer patients whose tumours have RAS mutations or for whom RAS tumour status is unknown
• Haemoglobin < 9 g/dL
• Leukocyte count < 3000/mm³
• Absolute neutrophil count < 1500/mm³
• Platelet count < 100000/mm³

Forms avail. in SA and covered in this monograph: inj

Used for the treatment of

Epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer
Squamous cell cancer of the head and neck
- Locally advanced disease
- Recurrent or metastatic disease (additional agent required)

Consult specialist for dosages and regimens

Not established for use in children below 18 years

Pregnancy

• FDA Pregnancy Category C

Breastfeeding

• Caution; not recommended

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly            

• No dose adjustment recommended

Central Nervous System Disorders

• Headache
• Aseptic meningitis

Cardiovascular Disorders

• Deep vein thrombosis

Respiratory Disorders

• Pulmonary embolism
• Interstitial lung disease

Gastrointestinal Disorders

• Diarrhoea
• Nausea and vomiting

Hepatobiliary Disorders

• Increase in hepatic enzyme levels

Endocrine and Metabolic Disorders

• Hypomagnesaemia
• Dehydration
• Hypocalcaemia
• Anorexia 
• Decreased weight 

Skin and Subcutaneous Tissue Disorders

• Skin reactions
• Stevens-Johnson syndrome
• Toxic epidermal necrolysis
• Superinfection of skin lesions
• Infusion-related reactions
• Mucositis

Sensory Disorders

• Conjunctivitis
• Blepharitis
• Keratitis

• Platinum-based chemotherapy
• Fluoropyrimidines
• Capecitabine 
• Oxaliplatin 

• Vital signs
• Electrolytes

Cetuximab is a chimeric monoclonal IgG antibody that is specifically directed against the epidermal growth factor receptor (EGFR). EGFR signalling pathways are involved in the control of cell survival, cell cycle progression, angiogenesis, cell migration and cellular invasion/metastasis. Cetuximab blocks binding of endogenous EGFR ligands resulting in inhibition of the function of the receptor. It further induces the internalisation of EGFR, which can lead to down-regulation of EGFR. Cetuximab also targets cytotoxic immune effector cells towards EGFR-expressing tumour cells (antibody dependent cell-mediated cytotoxicity, ADCC).

Injection (per ml) 5mg

• Erbitux (Merck) Originator