Serious and potentially fatal infusion reactions may occur and require immediate interruption of the cetuximab infusion and permanent discontinuation from further treatment. Cardiopulmonary arrest and/or sudden death have been reported in patients with squamous cell carcinoma of the head and neck treated with radiation therapy and cetuximab. Monitoring of serum electrolytes during and after cetuximab therapy is recommended in these patients .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antineoplastic Agent
Pharmacologic Class: Monoclonal Antibody
Cetuximab is a monoclonal antibody. It is used to treat cancer in the colon and rectal area, and cancer in the head and neck area. cetuximab is usually given to patients who have already received other cancer treatments. Cetuximab should only be used in patients with metastatic (cancer that spreads to other parts of the body) colon or rectal cancer who have had a KRAS gene mutation test. This test helps the doctor decide whether the medicine will treat their cancer. Cetuximab interferes with the growth of cancer cells, which are then destroyed by the body.
Cetuximab interferes with the growth of cancer cells, which are then destroyed by the body. Since the growth of normal body cells may also be affected by cetuximab, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, such as a skin rash, may not be serious but may cause concern. Some effects do not occur until months or years after the medicine is used.
Before you begin treatment with cetuximab, you and your doctor should talk about the good cetuximab will do as well as the risks of using it.
Cetuximab will only be given by or under the immediate supervision of your doctor.
cetuximab is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For cetuximab, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to cetuximab or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of cetuximab in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cetuximab in the elderly.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of cetuximab. Make sure you tell your doctor if you have any other medical problems, especially:
You will receive cetuximab while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you cetuximab. cetuximab is given through a needle placed in one of your veins. Cetuximab needs to be given slowly, so the needle will remain in place for at least an hour. The first dose of cetuximab could take two hours to give.
cetuximab sometimes causes nausea and vomiting. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. Ask your doctor for ways to lessen these effects.
It is very important that your doctor check your progress at regular visits to make sure that cetuximab is working properly. Blood tests may be needed to check for unwanted effects.
Do not breastfeed while you are using cetuximab and for at least 60 days after you receive your last dose of cetuximab.
Cetuximab may cause a serious side effect called an infusion reaction. This can be life-threatening and require immediate medical attention. Tell your doctor or nurse right away if you have fever, chills, trouble with breathing, lightheadedness, fainting, or chest pain within a few hours after you receive it.
Serious skin reactions can occur with cetuximab. Check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using cetuximab.
cetuximab may make your skin more sensitive to sunlight. Use a sunscreen or sun-blocking lotion when you are outdoors. Wear protective clothing and hats. Avoid sunlamps and tanning beds.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:More common
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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