· 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). Erbitux is used:

· with another chemotherapy medicine called irinotecan in people whose EGFR-expressing metastatic colorectal cancer is not or no longer shrinking with irinotecan alone

· 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.

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 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.