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Anti-EGFR Monoclonal Antibody — Head and Neck Cancer Pregnancy: Can cause fetal harm when administered to a pregnant woman, based on animal findings and its mechanism of action; there are no available human data. Human IgG crosses the placenta. Advise pregnant women of the potential risk to a fetus and females of reproductive potential to use effective contraception.

Cetuximab

Brand names: Erbitux

Cetuximab is an intravenous monoclonal antibody against the epidermal growth factor receptor (EGFR) used, in combination with radiotherapy or chemotherapy, for locally advanced or recurrent/metastatic squamous cell carcinoma of the head and neck.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Initial dose 400 mg/m2, then 250 mg/m2 weekly
Route: Intravenous infusion
Frequency: Initial dose 400 mg/m2 as a 120-minute infusion one week prior to initiating radiotherapy, then 250 mg/m2 as a 60-minute infusion every week for the duration of radiotherapy (6-7 weeks)
US labelling (ERBITUX) - no UK SPC was available in the fetched bundle. Squamous cell carcinoma of the head and neck (SCCHN) in combination with radiation therapy: initial 400 mg/m2 over 120 minutes one week before starting radiotherapy, then 250 mg/m2 over 60 minutes weekly for the duration of radiotherapy (6-7 weeks); complete administration 1 hour prior to radiotherapy. As a single agent or in combination with platinum-based therapy and fluorouracil - weekly schedule: initial 400 mg/m2 over 120 minutes, subsequent doses 250 mg/m2 over 60 minutes weekly; biweekly schedule: 500 mg/m2 over 120 minutes every 2 weeks. Complete administration 1 hour prior to chemotherapy. Continue until disease progression or unacceptable toxicity. Premedicate with an intravenous histamine-1 receptor antagonist 30-60 minutes prior to the first dose and before subsequent doses as deemed necessary. Do NOT administer as an intravenous push or bolus; administer via infusion pump or syringe pump and do not exceed an infusion rate of 10 mg/min. Dosage modifications: grade 1 or 2 infusion reactions - reduce the infusion rate by 50%; grade 3 or 4 - immediately and permanently discontinue. Grade 3 or 4 dermatologic toxicity - delay infusion 1 to 2 weeks and, if the condition improves, resume at 250 mg/m2 (1st occurrence), 200 mg/m2 (2nd), 150 mg/m2 (3rd); discontinue at the 4th occurrence or if no improvement. Paediatric: safety and effectiveness in paediatric patients have not been established.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • None stated - US label section 4 CONTRAINDICATIONS reads 'None'

Side effects

  • Cutaneous adverse reactions including rash, pruritus and nail changes (incidence 25% or more)
  • Headache
  • Diarrhoea
  • Infection
  • Infusion reactions - any grade in 8.4% and severe (grade 3-4) in 2.2% of patients; can be serious and fatal
  • Hypomagnesaemia and accompanying electrolyte abnormalities - monitor during treatment and for at least 8 weeks after completion

Clinical monograph

How it works

It binds the EGFR, blocking ligand-induced receptor activation and downstream signalling that drives tumour growth, and is given as an intravenous infusion.

Prescribing in practice

  • Severe infusion-related and hypersensitivity reactions, including anaphylaxis, can occur (often with the first infusion), so premedication, slow administration and resuscitation facilities are required and patients must be monitored during and after infusion.
  • An acneiform skin rash is very common and its severity correlates with response, while hypomagnesaemia is frequent and requires electrolyte monitoring and replacement.
  • It is administered under specialist oncology supervision as part of defined regimens, not as monotherapy outside its licensed combinations.

Monitoring

Monitor for infusion reactions, serum magnesium and other electrolytes, and skin toxicity throughout treatment.

Counselling the patient

  • Report any rash, fever, breathlessness or faintness during or after the infusion straight away.
  • A spot-like skin rash is common; tell the team so it can be managed and protect skin from sun.
  • Regular blood tests are needed to check magnesium and other levels.

Evidence & guidelines

Cetuximab with radiotherapy improves outcomes in locally advanced head and neck squamous cell carcinoma and is established in oncology guidelines for selected patients.

Reference: Bonner Trial (NEJM 2006); EXTREME Trial (Vermorken et al. NEJM 2008); NICE TA145; SPC Erbitux; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.