Serious and potentially fatal infusion reactions may occur and require immediate interruption of the cetuximab infusion and permanent discontinuation. 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 or platinum-based therapy with 5-fluorouracil and cetuximab. Monitoring of serum electrolytes during and after cetuximab therapy is recommended .
Medically reviewed on Oct 31, 2018
Commonly used brand name(s)
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antineoplastic Agent
Pharmacologic Class: Monoclonal Antibody
Uses For cetuximab
Cetuximab injection is used together with radiation treatment for advanced squamous cell carcinoma of the head and neck (SCCHN), or with a platinum-based cancer medicine with fluorouracil to treat SCCHN that has come back (recurrent) or has spread to other parts of the body (metastatic). Cetuximab injection is also used alone in patients with recurrent or metastatic SCCHN who have received other medicines that did not work well.
Cetuximab injection is used together with other medicines (eg, irinotecan, fluorouracil, leucovorin) to treat K-Ras wild-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC). Your doctor will test for the presence of this gene mutation. Cetuximab injection is also used alone to treat patients with mCRC who have received other medicines (eg, irinotecan, oxaliplatin) that did not work well.
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 benefits of cetuximab as well as the risks of using it.
Cetuximab should only be given by or under the direct supervision of your doctor.
Before Using cetuximab
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 injection 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 injection in the elderly.
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.
Interactions with Medicines
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. When you are receiving cetuximab, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using cetuximab with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Interactions with Food/Tobacco/Alcohol
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.
Other Medical Problems
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:
- Allergy to red meat or tick bites—Use with caution. May increased risk of an allergic reaction to reoccur.
- Congestive heart failure, history of or
- Coronary artery disease, history of or
- Heart rhythm problems (eg, arrythmia), history of—May increase your risk for more side effects.
- Hypocalcemia (low calcium in the blood) or
- Hypokalemia (low potassium in the blood) or
- Hypomagnesemia (low magnesium in the blood) or
- Lung or breathing problems—Use with caution. May make these conditions worse.
Proper Use of cetuximab
A nurse or other trained health professional will give you cetuximab in a medical facility. It is given through a needle placed into one of your veins. Cetuximab needs to be given slowly, so the needle will have remain in place for at least an hour. The first dose of cetuximab could take at least 2 hours to give.
You may also receive medicines (eg, allergy medicine) to help prevent unwanted effects to the injection.
Cetuximab sometimes causes nausea and vomiting. However, it is very important that you continue to receive cetuximab, even if you begin to feel ill. Ask your doctor for ways to lessen these effects.
Precautions While Using cetuximab
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.
Using cetuximab while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with cetuximab and for 2 months after the last dose. If you think you have become pregnant while using cetuximab, tell your doctor right away.
Cetuximab may cause a serious side effect called an infusion reaction. This can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have a fever, chills, trouble with breathing, lightheadedness, fainting, or chest pain within a few hours after you receive it.
Tell your doctor or nurse right away if you have a cough, difficulty with breathing, or other breathing problems while being treated with cetuximab. These may be symptoms of a serious lung problem.
Serious skin reactions can occur with cetuximab. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, dry skin, grooves or lines in the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are receiving 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.
If you plan to have children, talk with your doctor before using cetuximab. Some women using cetuximab have become infertile (unable to have children).
Cetuximab Side Effects
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:
- Blemishes on the skin or pimples
- bloating or swelling of the face, arms, hands, lower legs, or feet
- body aches or pain
- deep cracks, grooves, or lines in the skin
- difficult or labored breathing
- lower back or side pain
- painful or difficult urination
- pale skin
- rapid weight gain
- runny nose
- severe dry skin
- skin rash
- tender, swollen glands in the neck
- tightness in the chest
- tingling of the hands or feet
- trouble with breathing on exertion
- trouble with swallowing
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- voice changes
- black, tarry stools
- chest pain
- decreased urination
- dry mouth
- fast heartbeat
- increase in heart rate
- rapid, shallow breathing
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- sunken eyes
- wrinkled skin
Incidence not known
- Blistering, peeling, or loosening of the skin
- cracked lips
- difficulty in swallowing
- joint or muscle pain
- red, irritated eyes
- red skin lesions, often with a purple center
- stiff neck or back
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:
- burning, dry, or itching eyes
- difficulty having a bowel movement
- discharge from the eye
- discoloration of the fingernails or toenails
- excessive tearing
- feeling sad or empty
- hair loss or thinning of the hair
- lack or loss of appetite
- lack or loss of strength
- loss of interest or pleasure
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
- stomach discomfort, upset, or pain
- swelling or inflammation of the mouth
- trouble concentrating
- trouble sleeping
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.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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