Erbitux ®

Brand Name	: Erbitux ®
Active Ingredient	: Cetuximab
Strength(s)	: 100mg/50 mL vial
Dosage Form(s)	: Injection
Company Name	: ImClone Systems Inc.; Bristol-Myers Squibb Co.
Availability	: Prescription only
Date Approved by FDA*	: February 12, 2004

*Approval by FDA does not mean that the drug is available for consumers at this time.

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). 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.

What should I tell my health care provider?

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

What are some possible side effects of Erbitux?

(This list is NOT a complete list of side effects reported with Erbitux. Your health care provider can discuss with you a more complete list of side effects.)

Serious side effects of Erbitux include:

infusion reaction
skin reactions
lung disease
fever
infection in the blood
kidney failure
blood clot in the lung
loss of water and salt from the body (dehydration)
diarrhea

The most common side effects of Erbitux include:

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

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