ERBITUX®
cetuximab (rmc)
CONSUMER MEDICINE INFORMATION
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Erbitux. It does not contain all the information that is known about Erbitux. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.
What ERBITUX is used for
ERBITUX is used to treat certain cancers that have a protein on their cell surface called EGFR (epidermal growth factor receptor). When a growth factor called EGF attaches to EGFR it turns on signals within the cell causing it to grow and divide to form more cells. In many human tumours, there is an over-activation of these receptors, which leads to increased uncontrolled growth of cancer cells and development into a tumour.
How ERBITUX works
The active substance in ERBITUX is cetuximab. It belongs to a group of medicines called monoclonal antibodies. Monoclonal antibodies are proteins that specifically recognise and attach to other unique proteins. ERBITUX attaches to the EGFR more tightly than EGF and thereby interferes with growth of cancer cells.
What ERBITUX does
ERBITUX is used to treat metastatic colorectal cancer (cancer of the colon or large intestine and rectum that has spread to other parts of the body). It may be used alone or in combination with certain types of medicines called chemotherapy to treat metastatic colon cancer.
Before you are prescribed ERBITUX, your doctor will test your cancer cells to see if they contain either the normal (wild-type) or mutant form of a gene called K-RAS. ERBITUX is used to treat patients who express a normal K-RAS gene. Patients who express a mutation in their K-RAS gene or for whom the K-RAS status is not known should not be treated with ERBITUX.
ERBITUX is used to treat locally advanced head and neck cancer, in combination with radiation therapy. It is also used to treat head and neck cancer that has reoccurred or spread to other parts of the body in combination with certain types of chemotherapy.
Ask your doctor if you have any questions about why ERBITUX has been prescribed for you.
Your doctor may have prescribed it for another use.
ERBITUX is available only with a doctor's prescription.
There is no evidence that ERBITUX is addictive.
Use in Children
ERBITUX is not recommended for use in children under the age of 18 years, as its safety and effectiveness have not been established in this age group.
Before starting treatment with ERBITUX
When you must not have it
Do not have ERBITUX if you experience severe hypersensitivity (allergic) reactions to cetuximab.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
If you have had an allergic reaction to ERBITUX, your doctor will decide whether or not you can receive it again. This will depend on the severity of your reaction.
Do not have ERBITUX if you are allergic to any of the ingredients listed at the end of this leaflet.
If you receive ERBITUX in combination with chemotherapy medicines, ask your doctor or p