Individual generic drug information

cetuximab

Reference monograph

Part of registered formulation

CETUXIMAB

Reference record: Cetuximab
Source: BNF 80 (2020–2021)
Printed source pages: 936
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Cetuximab only.

Indications And Dose

Treatment of wild-type RAS metastatic colorectal cancer in patients with tumours expressing epidermal growth factor receptor, as combination therapy, or as monotherapy if oxaliplatin- and irinotecan-based therapy has failed or if irinotecan is not tolerated | Treatment of locally advanced squamous cell cancer of the head and neck (in combination with radiotherapy) | Treatment of recurrent or metastatic squamous cell cancer of the head and neck (in combination with Immune system and malignant disease platinum-based chemotherapy) ▶BY INTRAVENOUS INFUSION ▶Adult (initiated by a specialist): (consult product literature or local protocols)

Source page 936

Contra Indications

RAS mutated colorectal tumours (or if RAS tumour status unknown)

Source page 936

Cautions

Cardiopulmonary disease. cardiovascular disease. history of keratitis. pulmonary disease— discontinue if interstitial lung disease. risk factors for keratitis. severe dry eye. ulcerative keratitis (including contact lens use)

Source page 936

Pre Treatment Screening

Evidence of non-mutated (wild-type) RAS status (at exons 2, 3 and 4 of KRAS and NRAS) is required before cetuximab is initiated for the treatment of metastatic colorectal cancer, and should be determined by an experienced laboratory using a validated test method.

Source page 936

National Funding Access Decisions

NICE decisions ▶Cetuximab for the treatment of locally advanced squamous cell cancer of the head and neck (June 2008) NICE TA145 Cetuximab in combination with radiotherapy is an option for the treatment of locally advanced squamous cell cancer of the head and neck in patients who have a Karnofsky performance status of 90% or greater and when all forms of platinum-based chemoradiotherapy treatment are contra-indicated. www.nice.org.uk/guidance/ta145 ▶Cetuximab, bevacizumab and panitumumab for the treatment of metastatic colorectal cancer after first-line chemotherapy (January 2012) NICE TA242 Cetuximab monotherapy or combination chemotherapy is not recommended for the treatment of patients with metastatic colorectal cancer that has progressed after ﬁrst- line chemotherapy. www.nice.org.uk/guidance/ta242 ▶Cetuximab and panitumumab for previously untreated metastatic colorectal cancer (updated September 2017) NICE TA439 Cetuximab is recommended, within its marketing authorisation, as an option for previously untreated epidermal growth factor receptor-expressing, RAS wild- type metastatic colorectal cancer in patients in combination with: . 5-ﬂuorouracil, folinic acid and oxaliplatin (FOLFOX), or . 5-ﬂuorouracil, folinic acid and irinotecan (FOLFIRI). This advice is contingent upon the manufacturer providing cetuximab with the discount agreed in the commercial access agreement. www.nice.org.uk/guidance/ta439 ▶Cetuximab for treating recurrent or metastatic squamous cell cancer of the head and neck (August 2017) NICE TA473 Cetuximab in combination with platinum-based chemotherapy is recommended as an option for treating recurrent or metastatic squamous cell cancer of the head and neck in patients only: . if the cancer started in the oral cavity, and . when the company provides the drug in line with the commercial access agreement with NHS England. Patients currently receiving cetuximab whose disease does not meet the above criteria may continue treatment until they and their clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta473

Source page 936

Safety

Extracted information for Cetuximab only.

Important Safety Information

Patients must receive an antihistamine and a corticosteroid at least one hour before infusion. Resuscitation facilities should be available and treatment should be initiated by a specialist. MHRA/CHM ADVICE: EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) INHIBITORS: SERIOUS CASES OF KERATITIS AND ULCERATIVE KERATITIS (MAY 2012) Keratitis and ulcerative keratitis have been reported following treatment with epidermal growth factor receptor (EGFR) inhibitors for cancer (cetuximab, erlotinib, geﬁtinib and panitumumab). In rare cases, this has resulted in corneal perforation and blindness. Patients undergoing treatment with EGFR inhibitors who present with acute or worsening signs and symptoms suggestive of keratitis should be referred promptly to an ophthalmology specialist. Treatment should be interrupted or discontinued if ulcerative keratitis is diagnosed.

Source page 936

Interactions

→Appendix 1: monoclonal antibodies

Source page 936

Side Effects

▶Common or very common Appetite decreased. cytokine release syndrome. dehydration. diarrhoea. electrolyte imbalance. eye inﬂammation. fatigue. headache. infusion related reaction. mucositis. nausea. skin eruption. vomiting ▶Uncommon Embolism and thrombosis. interstitial lung disease ▶Rare or very rare Severe cutaneous adverse reactions (SCARs) ▶Frequency not known Meningitis aseptic. superinfection of skin lesions

Source page 936

Conception And Contraception

Contraceptive advice required, see Pregnancy and reproductive function in Cytotoxic drugs p. 938.

Source page 936

Pregnancy

Use only if potential beneﬁt outweighs risk— no information available. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.

Source page 936

Breast Feeding

Avoid breast-feeding during and for 2 months after treatment—no information available.

Source page 936

Dose and formulations

Extracted information for Cetuximab only.

Directions For Administration

Resuscitation facilities should be available.

Source page 936

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Solution for infusion ▶Erbitux (Merck Serono Ltd) Cetuximab 5 mg per 1 ml Erbitux 100mg/20ml solution for infusion vials | 1 vial P £178.10 (Hospital only) Erbitux 500mg/100ml solution for infusion vials | 1 vial P £890.50 (Hospital only)

Source page 936

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

(consult product

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 936

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.

Individual generic drug information

cetuximab

Reference monograph

Part of registered formulation

CETUXIMAB

Reference record: Cetuximab
Source: BNF 80 (2020–2021)
Printed source pages: 936
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Cetuximab only.

Indications And Dose

Source page 936

Contra Indications

RAS mutated colorectal tumours (or if RAS tumour status unknown)

Source page 936

Cautions

Source page 936

Pre Treatment Screening

Source page 936

National Funding Access Decisions

Source page 936

Safety

Extracted information for Cetuximab only.

Important Safety Information

Source page 936

Interactions

→Appendix 1: monoclonal antibodies

Source page 936

Side Effects

Source page 936

Conception And Contraception

Contraceptive advice required, see Pregnancy and reproductive function in Cytotoxic drugs p. 938.

Source page 936

Pregnancy

Use only if potential beneﬁt outweighs risk— no information available. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.

Source page 936

Breast Feeding

Avoid breast-feeding during and for 2 months after treatment—no information available.

Source page 936

Dose and formulations

Extracted information for Cetuximab only.

Directions For Administration

Resuscitation facilities should be available.

Source page 936

Medicinal Forms

Source page 936

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

(consult product

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 936

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.