Erbitux, illustration of injection vial form (not a photo of the actual pack)

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Erbitux

Cetuximab

Prescription required

$1655.00

500mg · 500 vial

BrandBranded medicine· By Merck

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100mg

500mg

FDA boxed warningInfusion reactions and cardiopulmonary arrest

Infusion Reactions: ERBITUX can cause serious and fatal infusion reactions

. Immediately interrupt and permanently discontinue ERBITUX for serious infusion reactions

Cardiopulmonary Arrest: Cardiopulmonary arrest or sudden death occurred in patients with squamous cell carcinoma of the head and neck receiving ERBITUX with radiation therapy or a cetuximab product with platinum-based therapy and fluorouracil. Monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after ERBITUX administration

Cardiopulmonary arrest or sudden death occurred in patients with squamous cell carcinoma of the head and neck receiving ERBITUX with radiation therapy or with a cetuximab product with platinum-based therapy and fluorouracil. Monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after ERBITUX administration.

Read this with the rest of the clinical information

About Erbitux

Overview

Erbitux (cetuximab) is a monoclonal antibody medicine given into a vein. It treats certain squamous cell cancers of the head and neck, alone or with radiation therapy or chemotherapy. It also treats selected colorectal cancers that have spread, with its use depending on tumour test results and previous treatment. It works by binding to EGFR, a protein on cells, and blocking signals that support cell growth.

What it treats

- Squamous cell cancer of the head and neck: with radiation therapy for locally or regionally advanced disease; with platinum-based chemotherapy and fluorouracil for recurrent locoregional or metastatic disease; or alone for recurrent or metastatic disease that has progressed after platinum-based therapy. - Metastatic colorectal cancer that is K-Ras wild-type and EGFR-expressing, confirmed by an FDA-approved test: with FOLFIRI as first-line treatment; with irinotecan when irinotecan-based chemotherapy has not worked; or alone after oxaliplatin- and irinotecan-based chemotherapy have failed, or when irinotecan cannot be tolerated. Erbitux is not indicated for Ras-mutant colorectal cancer or when Ras mutation test results are unknown. - Metastatic colorectal cancer with a BRAF V600E mutation, confirmed by an FDA-approved test, in adults after prior treatment, in combination with encorafenib.

Safety information

Side effects

Common side effects of Erbitux include skin rash, itching, nail changes, headache, diarrhea and infections. When used with encorafenib, common side effects include tiredness, nausea, diarrhea, an acne-like rash, abdominal pain, reduced appetite, joint pain and rash. Serious risks include infusion reactions, cardiac and respiratory arrest, lung toxicity, severe skin problems and related infections, and low magnesium or other electrolyte abnormalities. Contact your doctor immediately for an infusion reaction, new or worsening breathing symptoms, severe skin problems or signs of infection. Serious infusion reactions require immediate stopping and permanent discontinuation of Erbitux. Electrolytes need monitoring during treatment and for at least eight weeks after treatment ends. Limit sun exposure. Erbitux can harm an unborn baby. Use effective contraception and contact your doctor if you become pregnant. In patients with RAS-mutant metastatic colorectal cancer, increased tumor progression, increased risk of death or lack of benefit have been observed.

FDA boxed warning

Infusion reactions and cardiopulmonary arrest

Infusion Reactions: ERBITUX can cause serious and fatal infusion reactions

. Immediately interrupt and permanently discontinue ERBITUX for serious infusion reactions

Cardiopulmonary Arrest: Cardiopulmonary arrest or sudden death occurred in patients with squamous cell carcinoma of the head and neck receiving ERBITUX with radiation therapy or a cetuximab product with platinum-based therapy and fluorouracil. Monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after ERBITUX administration

Cardiopulmonary arrest or sudden death occurred in patients with squamous cell carcinoma of the head and neck receiving ERBITUX with radiation therapy or with a cetuximab product with platinum-based therapy and fluorouracil. Monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after ERBITUX administration.

A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.

When to call your doctor

- Seek medical attention immediately for new or worsening breathing problems. - Seek urgent medical attention for a severe rash or other severe skin changes, especially if accompanied by signs of infection.

If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.

Before taking this medicine

The supplied FDA label lists no contraindications. However, Erbitux has important warnings and requires close monitoring. Serious infusion reactions require the infusion to be stopped immediately and Erbitux permanently discontinued. Patients should be monitored after infusions. Cardiac and breathing arrest have been reported; blood electrolyte levels must be monitored during and after treatment. Low magnesium and other electrolyte abnormalities require monitoring during treatment and for at least 8 weeks after it ends, with replacement as needed. New or worsening lung symptoms may require treatment to be interrupted or permanently stopped. Skin reactions and related infections require monitoring. Limit sun exposure. In patients with RAS-mutant metastatic colorectal cancer, increased tumour progression, increased mortality or lack of benefit have been observed. Erbitux can harm an unborn baby. Women who could become pregnant should use effective contraception. Do not breastfeed during treatment.

Using Erbitux

Dosing

Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.

Storage

Store in the original carton below 25°C, protected from light, unless the pack states refrigeration. Do not freeze. Keep all medicines out of the sight and reach of children.

Clinical information on this page is summarised from the US FDA label ERBITUX (CETUXIMAB) SOLUTION [IMCLONE LLC] (DailyMed, retrieved 19 September 2026).

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