Things to know about Erbitux

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Consumer Drug Information Sheet

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

Reports of patients’ experience after Erbitux became available:

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

or pharmacist.

Erbitux's Approved label

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Date created: May 26, 2004

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