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cetuximab

Erbitux · ATC code L01FE01

Key facts
Active substance
cetuximab
ATC code
L01FE01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Erbitux 5 mg/mL solution for infusion
Marketing authorisation holder
Merck Europe B.V.
Information as of
2026-10-27

Key facts

Cetuximab is a monoclonal antibody directed against the epidermal growth factor receptor (EGFR). It is used in metastatic colorectal cancer and in squamous cell cancer of the head and neck.

What it is used for

  • EGFR-expressing, RAS wild-type metastatic colorectal cancer: with irinotecan-based chemotherapy, first-line with FOLFOX, or as a single agent after failure of oxaliplatin and irinotecan
  • BRAF V600E mutant metastatic colorectal cancer in adults: with encorafenib and FOLFOX (first line) or with encorafenib after prior systemic therapy
  • Squamous cell cancer of the head and neck: with radiation therapy (locally advanced) or with platinum-based chemotherapy (recurrent/metastatic)

Dosing

  • Premedication with an antihistamine and a corticosteroid at least 1 hour before each infusion; monitor for at least 1 hour after the infusion
  • Weekly regimen: initial dose 400 mg/m² body surface area, then 250 mg/m² weekly
  • Every-other-week regimen (RAS wild-type colorectal cancer; with encorafenib and FOLFOX): 500 mg/m² every other week
  • Evidence of RAS wild-type or BRAF V600E mutation status is required before treatment
  • Head and neck cancer with radiotherapy: start one week before radiation, weekly regimen; further details in the full text

Contraindications

  • Known severe (grade 3 or 4) hypersensitivity reactions to cetuximab
  • Combination with oxaliplatin-containing chemotherapy in mutant RAS or unknown RAS status mCRC

Important warnings

  • Severe infusion-related and anaphylactic reactions, sometimes fatal and possibly delayed; discontinue immediately and permanently if severe
  • Interstitial lung disease, including fatal cases; discontinue if diagnosed
  • Very common, sometimes severe skin reactions with risk of secondary infections
  • Hypomagnesaemia, hypokalaemia and hypocalcaemia; check electrolytes before and during treatment
  • With platinum-based chemotherapy, more severe neutropenia and infectious complications

Side effects

  • Skin reactions in more than 80% of patients
  • Hypomagnesaemia in more than 10%
  • Infusion-related reactions: mild to moderate in more than 10%, severe in more than 1%
  • Others: mucositis, increased liver enzymes, nausea, diarrhoea, fatigue

Interactions

  • Platinum-based chemotherapy: more frequent severe leukopenia/neutropenia and infectious complications
  • Fluoropyrimidines: more cardiac ischaemia, heart failure and hand-foot syndrome
  • Capecitabine plus oxaliplatin (XELOX): more severe diarrhoea
  • No pharmacokinetic interaction with irinotecan

Pregnancy and breastfeeding

  • Use in pregnancy or without adequate contraception only if the benefit for the mother justifies the potential risk to the foetus
  • Do not breast-feed during treatment and for 2 months after the last dose

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • ErbituxMerck Europe B.V. · EMEA/H/C/000558

Source: European Medicines Agency (EMA), product information

Turkey

  • ErbituxMERCK İLAÇ ECZA VE KİMYA TİC. A.Ş. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Erbitux
Liechtenstein
Erbitux
Norway
Erbitux

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Erbitux – EPAR, Product Information (OF THE TEXT MM/YYYY Detailed information on this medicinal p). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/erbitux-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.