Composition
Inj: Per ml: Cetuximab 5 mg; 20 ml vial.
Indications & Dosage
Treatment of wild-type RAS metastatic colorectal cancer in patients with tumours expressing epidermal growth factor receptor, as combination therapy, or as monotherapy, Locally advanced squamous cell cancer of the head and neck in combination with radiotherapy or platinum-based chemotherapy: BY IV INF: Adults: Initially400 mg/1V IV INF over 120 min. Maintenance: 250 mg/ mu IV INF over 60 min once weekly. Max INF Rate: 5 ml/min. Children: Not recommended.
Administration
Do not administer as an IV push or bolus. Administered via infusion or syringe pump. Administer initial dose over 120 min. then administer subsequent dose over 60 min. The maximum infusion rate is 5 ml/min (10 mg/min). Administer cetuximab through a low protein-binding 0.22 micrometer in-line filter Observe patient for 1 hour after administration. Flush lines with 0.9 % NaCI injection after IV injection.
Stability
Store vials under refrigeration at 2C-8C (36F-46F) and up to 8 hours at controlled room temperature 20C-25C (68F -77F). Discard any remaining solution in the infusion container after 8 at controlled room temperature or after 12 hours at 2C-8C (36F -46F). Discard any unused portion of the vial.
Precautions
Cardiopulmonary disease, cardiovascular disease, history of keratitis, pulmonary disease; discontinue if interstitial lung disease, severe dry eye, ulcerative keratitis (including contact lens use). Monitor serum electrolyle levels. In case of severe skin reactions, discontinue. Severe neutropenia may occur when combined with platinum-based chemotherapy.
Interactions
Platinum-based chemotherapeutic agents.5-FU.
Pregnancy
Positive evidence of risk: Avoid
Lactation
Contraindicated. Discontinue breast-feeding.
Side Effects
Aseptic meningitis, blepharitis, bronchospasm, chills, conjunctivitis, desquamation, diarrhoea, dizziness, dry skin, dyspnea, fever, headache, hypertension, hypertrichosis, hypocalcaemia, hypomagnesaemia, hypotension, infusion-related reactions, keratitis, nail disorders, nausea, pruritus, rash, severe hypersensitivity reactions, shock, skin reactions, urticaria, vomiting. Rare: Stevens-Johnson syndrome, toxic epidermal necrolysis