Cetuximab, Injection

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KEY POINTS

• This medicine is given by IV to treat colorectal cancer or head and neck cancer.
• Both males and females should use an effective method of birth control while receiving this medicine and for at least 6 months after therapy is completed.
• You may get infections more easily when you are taking this medicine.
• This medicine may cause unwanted side effects, including serious or life-threatening infusion reactions. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer); monoclonal antibody

Generic and brand names: cetuximab, injection; Erbitux

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein) to treat:

• Colorectal cancer
• Head and neck cancer

It may be given alone or with other medicines.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Heart disease, heart rhythm problems, or a heart attack
• Kidney disease
• Low levels of magnesium, potassium, or calcium in your blood
• Lung disease such as asthma or COPD

Tell your healthcare provider if you have any kind of infection, including an eye infection.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Use an effective method of birth control while you are receiving this medicine and for at least 6 months after your therapy is completed. Do not breast-feed while taking this medicine or for 2 months after you receive this medicine.

Males: Men who receive this medicine should always use a condom when having sex with a woman who may become pregnant. Do this during treatment with this medicine or for 6 months after stopping treatment.

How do I use it?

The infusions are usually given once a week by your healthcare provider. You will be watched carefully for at least 1 hour after you receive each dose to make sure that you do not have a serious reaction. Be sure to keep all appointments for these infusions and for blood tests to find out how this medicine affects you.

Your provider may suggest that you take diphenhydramine (Benadryl) before each infusion to help reduce any side effects. Your healthcare provider may also prescribe other medicines to reduce nausea and diarrhea, which are common side effects of this medicine. Follow your healthcare provider's directions exactly.

What should I watch out for?

This medicine may cause serious or life-threatening infusion reactions. Tell your healthcare provider right away if you have:

• Flushing
• Itching
• Changes in heart rate
• Shortness of breath or wheezing
• Back pain
• Fever and chills
• Nausea
• Skin rashes
• Swelling of the face, mouth, tongue, or throat
• Dizziness or fainting

This medicine has caused life-threatening side effects, including heart attacks, in a small number of people. Talk with your healthcare provider about this.

Both males and females should use an effective method of birth control while you are receiving this medicine and for at least 6 months after your therapy is completed. Talk with your healthcare provider about this.

This medicine may make your skin more sensitive to the sun, which may lead to painful sunburns. While you are taking this medicine and for 2 months after you stop taking the medicine, avoid long exposure to the sun. Wear protective clothing, a hat, and sunscreen lotion when you need to be outdoors. Do not use a sunlamp. If you get a severe sunburn, contact your healthcare provider right away.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines without getting your healthcare provider's approval first. If you develop a fever (over 100°F, or 37.8°C), contact your healthcare provider right away.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Chest pain, new or worsening breathing problems, severe dizziness or fainting, severe and prolonged diarrhea, fever, cough, sore throat, severe nausea or vomiting, loss of appetite, sores in your mouth or on your lips, unusual bruising or bleeding, blistering or peeling skin, severe skin redness or rash, pain or swelling around nails, confusion, thinking problems, muscle pain or weakness, fast or irregular heartbeat, mood changes, seizures, decreased urination, burning or numbness in hands or feet, severe headache.

Other: Constipation, diarrhea, stomach pain, mild headache, joint pain, chills, weakness, tiredness, acne; dry skin, nail changes, dry or red eyelids, dry mouth, weight loss, trouble sleeping, mild dizziness, hair loss.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Other cancer medicines
• Vaccines

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.