Cetuximab Intravenous

In the U.S.

• Erbitux

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Monoclonal Antibody

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 2 hours to give.

You may also receive medicines (e.g., diphenhydramine) to help prevent possible allergic reactions to the injection.

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.

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
• chills
• congestion
• cough or hoarseness
• deep cracks, grooves, or lines in the skin
• difficult or labored breathing
• dizziness
• facial swelling
• fever
• headache
• lower back or side pain
• nausea
• painful or difficult urination
• pale skin
• rapid weight gain
• runny nose
• severe dry skin
• shortness of breath
• 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
• weakness
• wheezing

• 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
• swollen glands
• thirst
• wrinkled skin

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:

• Acid or sour stomach
• belching
• burning, dry, or itching eyes
• diarrhea
• difficulty having a bowel movement (stool)
• 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
• itching skin
• 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
• unable to sleep

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.

(see also Warning section)

Nausea, vomiting, constipation, diarrhea, headache, stomachache, backache, fever/chills, trouble sleeping, weight loss, fatigue, drowsiness, eye redness/itching, nail changes, dry skin, and mouth/throat sores may occur. Nausea and vomiting can be quite severe. In some cases, drug therapy may be necessary to prevent or relieve nausea and vomiting. Not eating before your treatment may help relieve vomiting. Changes in diet such as eating several small meals or limiting activity may help lessen some of these effects. If these effects persist or worsen, notify your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk ofside effects. Careful monitoring by your doctor may decrease your risk.

An acne-like rash may occur. Depending on how severe this rash is, your doctor may delay your cetuximab treatment, lower your dose, treat the rash with antibiotics, or stop treatment with cetuximab to decrease this potentially serious side effect.

Tell your doctor right away if any of these unlikely but serious side effects occur: confusion, depression, swelling of hands/feet/lower legs, dehydration, serious infection (e.g., high fever, chills, persistent sore throat), signs of kidney problems (such as change in the amount of urine), decreased vision, severe dizziness, fast/slow/irregular heartbeat, severe muscle spasms.

Rarely, very serious lung problems may occur. Seek immediate medical attention if you develop: trouble breathing.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before receiving cetuximab, tell your doctor or pharmacist if you are allergic to it, or if you have a severe allergy to meat (such as beef, pork), or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: lung disease, radiation therapy, heart disease (e.g., coronary artery disease, congestive heart failure, arrhythmias), tick bites.

This drug may make you drowsy. Alcohol or marijuana can make you more drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

Sunlight may worsen any skin reactions that may occur while you are using this drug. Avoid prolonged sun exposure, tanning booths, and sunlamps during treatment and for 2 months after your last treatment with cetuximab. Use a sunscreen and wear protective clothing when outdoors.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. It is important that men and women using this medication use reliable forms of birth control (such as condoms, birth control pills) while using this medication and for 6 months after treatment stops.

Based on information from related drugs, cetuximab may pass into breast milk. Because of potential harm to the infant, breast-feeding is not recommended while using cetuximab and for 2 months after the end of treatment. Consult your doctor before breast-feeding.