Cetuximab


Cetuximab (marketed as Erbitux)

This is a summary of the most important information about Erbitux. For details, talk to your healthcare professional.

What is Erbitux used for?

Erbitux is a chemotherapy medicine (medicine used to kill cancer cells) that is given in a vein (I.V. infusion). It is used to treat a type of cancer of the colon or rectum that has spread to other areas of the body (EGRF-expressing metastatic colorectal carcinoma) and to treat certain cancers of the head and neck of the squamous cell type.

For cancer of the colon and rectum, Erbitux is used:

* in combination with another chemotherapy medicine called irinotecan in people whose EGFR-expressing metastatic colorectal cancer is not or no longer shrinking with irinotecan alone
* or, alone in people with EGFR-expressing metastatic colorectal cancer who cannot take irinotecan

At this time, it is not known whether Erbitux will improve symptoms of EGFR- expressing colorectal cancer or help these patients to live longer.

For cancer of the head and neck (squamous cell type), Erbitux is used:

* in combination with radiation treatment as the first treatment for people with advanced cancer in the head and neck area.
* or, alone in people with a tumor that has recurred or has spread to other sites of the body after initial treatment with surgery and/or radiation treatment and after platinum-based therapy has failed.

In a research study in patients with untreated head and neck cancer of squamous cell type, Erbitux in combination with radiation was shown to help patients live longer and to prolong time to tumor growth when compared with radiation treatment alone. In a second research study in patients with metastatic or recurrent cancer of the head and neck, who had tumor growth following local treatment (surgery and/or radiation) and after platinum chemotherapy, Erbitux alone was shown to cause tumor shrinkage in 13 out of 103 patients with.

Special Warnings with Erbitux:

* Erbitux may cause severe reactions during I.V. infusion that may result in death. The reactions include symptoms that happen suddenly such as trouble breathing, an itchy swelling on the skin (hives), and low blood pressure. These severe reactions can happen with any Erbitux infusion, but have happened more often the first time Erbitux is given. People that have severe infusion reactions with Erbitux must have their infusion stopped right away, and cannot be treated with Erbitux again.
* Erbitux in combination with radiation treatment may increase the chance of heart arrest and death. People who have heart trouble should inform their physician and be followed closely during and after treatment.
* Erbitux may cause a serious lung condition called interstitial lung disease that results in inflammation, scarring, and hardening of the lungs.
* Erbitux often causes skin reactions such as an acne-like rash, drying, cracking, inflammation, and infections. These reactions may be worsened by sun exposure.

General Precautions with Erbitux:

* Wear sunscreen, hats, and protective clothing, and limit sun exposure during treatment with Erbitux.
* Women who can become pregnant should avoid pregnancy and use contraception during treatment with Erbitux.

Women should not breastfeed during treatment with Erbitux and for 60 days after the last dose.

What should I tell my healthcare provider?

Tell your healthcare provider if you are allergic to any of the ingredients of Erbitux.

Tell your healthcare provider if you have a heart condition.

What are some possible side effects of Erbitux? (This list is NOT a complete list of side effects reported with Erbitux. Your healthcare provider can discuss with you a more complete list of side effects.)

Serious side effects of Erbitux include:

* infusion reaction (difficulty breathing, low blood pressure)
* skin reactions (rash, peeling/skin damage)
* lung disease
* fever
* infection in the blood
* kidney failure
* blood clot in the lung
* loss of water and salt from the body (dehydration)
* diarrhea

In addition to the above, serious side effects of Erbitux when used in combination with radiation treatment include:

* cardiopulmonary arrest
* mouth sores that prevent swallowing of liquids
* severe radiation skin reaction
* confusion

The most common side effects of Erbitux include:

* acne-like rash
* tiredness
* diarrhea
* nausea
* abdominal pain
* vomiting
* fever
* constipation

In addition to the above, common side effects of Erbitux when used in combination with radiation treatment include:

* mouth sores
* radiation skin rash
* weight loss
* dry mouth
* difficulty swallowing

For more detailed information about Erbitux, ask your healthcare provider or pharmacist.


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