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Patient Information Sheet
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.
Link
to Erbitux's Approved Labeling
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Date created: May 26, 2004
Updated: August 9, 2006 |
