Cetuximab

Cytostatic · Monoclonal antibody

Indications

In combination with irinotecan for the treatment of epidermal growth factor receptor-expressing metastatic colorectal cancer after failure of irinotecan-containing therapy. In combination with radiotherapy for the treatment of locally advanced squamous cell cancer of the head and neck.

Dosage

Metastatic colorectal carcinoma: Adults: Initial: 400 mg/m² IV infusion over 120 min. Maintenance: 250 mg/m² IV infusion over 60 min once weekly. Max Infusion Rate: 5 mL/min. Children: Not recommended.

Administration

Do not administer as an IV push or bolus. Administered via infusion pump or syringe pump. Administer initial dose over 120 min, then administer subsequent dose over 60 min. The maximum inf 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 % NaCl injection after IV injection. Stability: Store vials under refrigeration at 2°C-8°C (36°F-46°F). Do not freeze. Preparations of cetuximab in infusion containers are chemically and physically stable for up to 12 hours at 2°C-8°C (36°F-46°F) and up to 8 hours at controlled room temperature 20°C-25°C (68°F-77°F). Discard any remaining solution in the infusion container after 8 hours at controlled room temperature or after 12 hours at 2°C-8°C (36°F-46°F). Discard any unused portion of the vial.

Adverse Effects

Skin reactions, hypomagnesaemia, mild or moderate infusion-related reactions. Mild or moderate mucositis leading to epistaxis. Increased liver enzyme levels. Headache, conjunctivitis, diarrhoea, nausea, vomiting, fatigue, dehydration in particular secondary to diarrhoea or mucositis, hypocalcaemia, anorexia, GI upset.

Risk Factor (Pregnancy/Lactation)

Pregnancy: Risk cannot be ruled out. Lactation: Contraindicated or not recommended. Contraindications: Pre-existing haematological disorders. Colorectal cancer with RAS mutations or unknown RAS status. Precautions: Monitor for infusion-related reactions. Special attention for patients with reduced performance status and preexisting cardiopulmonary disease. Discontinue if interstitial lung disease is diagnosed. Monitor serum electrolyte levels. In case of severe skin reactions, discontinue. Severe neutropenia may occur when combined with platinum-based chemotherapy. Renal or hepatic impairment. Severe dry eye, keratitis. Elderly.

Interactions

Platinum-based chemotherapeutic agents, 5-FU.

Advice to Patient

This medication is administered intravenously. Contact prescriber if there is fever, chills or difficulty in breathing. Avoid direct sunlight, wear sunscreen, proper eyewear and protective clothing to prevent photosensitivity. Males and females both should use an effective contraceptive during treatment and for 6 months after last dose.

Pharmacokinetics

Half-life elimination: Approx 112 hours.

Brands with this active ingredient

Compiled by Healify Pharmacy from published drug references. How we compile it →

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