Pronunciation:

se-TUX-i-mab

Brand Names:

• Erbitux

Dosage Forms:

• Solution

Warnings:

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 .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

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, cancer of the colon and rectum that has spread). 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 injection is also used together with encorafenib to treat metastatic colorectal cancer (CRC, cancer of the colon and rectum that has spread) and have the BRAF V600E mutations. Your doctor will use a special test to look for these mutations.

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.

This medicine should only be given by or under the direct supervision of your doctor.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

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.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cetuximab injection in the elderly.

Breast-feeding—

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.

Other 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 this medicine, 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 this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bacillus of Calmette and Guerin Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

Using this medicine 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.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Cholera Vaccine
• Ebola Zaire Vaccine, Live
• Influenza Virus Vaccine, Live
• Rotavirus Vaccine, Live

Other interactions—

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 this medicine. 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.

• Heart or blood vessel disease (eg, congestive heart failure, coronary artery disease)
• 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 This Medicine:

A nurse or other trained health professional will give you this medicine 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 this medicine could take at least 2 hours to give.

You may also receive medicines (eg, allergy medicine) to help prevent unwanted effects to the injection.

This medicine sometimes causes nausea and vomiting. However, it is very important that you continue to receive this medicine, even if you begin to feel ill. Ask your doctor for ways to lessen these effects.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for 2 months after the last dose. If you think you have become pregnant while using this medicine, 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 this medicine. These may be symptoms of a serious lung problem.

Serious skin reactions can occur with this medicine. 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 this medicine.

This medicine 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 this medicine. Some women using this medicine have become infertile (unable to have children).

Side Effects of This Medicine:

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

Blemishes on the skin or pimples

bloating or swelling of the face, arms, hands, lower legs, or feet

body aches or pain

chills

congestion

cough

deep cracks, grooves, or lines in the skin

difficult or labored breathing

dizziness

fever

headache

hoarseness

lower back or side pain

nausea

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

vomiting

Less common

Anxiety

black, tarry stools

chest pain

confusion

decreased urination

dry mouth

fainting

fast heartbeat

increase in heart rate

lightheadedness

rapid, shallow breathing

sore throat

sores, ulcers, or white spots on the lips or in the mouth

sunken eyes

thirst

wrinkled skin

Incidence not known

Blistering, peeling, or loosening of the skin

cracked lips

diarrhea

difficulty in swallowing

itching

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:

More common

Belching

burning, dry, or itching eyes

difficulty having a bowel movement

discharge from the eye

discoloration of the fingernails or toenails

discouragement

excessive tearing

feeling sad or empty

hair loss or thinning of the hair

heartburn

indigestion

irritability

lack or loss of appetite

lack or loss of strength

loss of interest or pleasure

pain

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

sleeplessness

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.