Erbitux

Generic name: Cetuximab

What is Erbitux?

Erbitux is used with chemotherapy (irinotecan) in the treatment of colorectal cancer, and with radiation therapy to treat cancer of the head and neck.

What is the most important information I should know about Erbitux?

Severe allergic reactions have occurred in some treated with Erbitux. Symptoms can include breathing problems, rash, itching, low blood pressure, and/or heart attack. Following administration of the drug, report any sings and symptoms of infusion reactions to your doctor.

Sudden death has occurred in some people with squamous cell carcinoma of the head and neck (SCCHN) treated with radiation therapy and Erbitux. Carefully consider the use of Erbitux in combination with radiation therapy if you have head and neck cancer and a history of coronary artery disease, congestive heart failure, or a heart beat that is not normal.

Do not drive or perform other possibly unsafe tasks until you know how you react to Erbitux; this drug may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines.

Erbitux may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Erbitux. If you must be outside for more than a short time, use sunscreen or wear protective clothing while you use Erbitux and for 2 months after your last dose.

If nausea, loss of appetite, vomiting, or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions on how to lessen these effects.

Erbitux may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.

When on Erbitux therapy, always use adequate contraception (such as a condom) when having sex. Do this for as long as you take Erbitux and for 6 months after your last dose of this medication. (This applies to both males and females who are on Erbitux therapy.)

Nursing is not recommended during Erbitux therapy and for at least 2 months following the last dose of this medication.

Who should not take Erbitux?

Do not begin treatment with Erbitux if you are allergic to any of its ingredients.

What should I tell my doctor before I take the first dose of Erbitux?

Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Erbitux. Also, talk to your doctor about your complete medical history, especially if you have lung problems, abnormal blood electrolyte levels, breathing problems, respiratory tract infections, a history of blood vessel problems, heart problems, heart failure, an irregular heartbeat, and if you are currently receiving radiation therapy or treatment with other types of chemotherapy.

What is the usual dosage?

The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

Colorectal Cancer (with chemotherapy or alone)

Adults: The recommended initial dose of Erbitux, with chemotherapy or alone, is 400 mg/m² initially given over a 2 hour period. (Maximum infusion rate is 10mg per minute.) The recommended subsequent weekly dose, either alone or in combination with chemotherapy, is 250 mg/m² over a 1 hour period until disease progression or toxicity occurs.

Head and Neck Cancer (with chemotherapy)

Adults: The recommended initial dose of Erbitux is 400 milligrams (mg)/m² initially given over a 2-hour period as an intravenous infusion. (Maximum infusion rate is 10 mg per minute.) Subsequently, the recommended weekly dose is 250 mg/m² over a 1-hour period until disease progression or toxicity occurs.

Head and Neck Cancer (with radiation)

Adults: The recommended initial dose of Erbitux is 400 milligrams (mg)/m² initially given over a 2-hour period one week prior to initiation of radiation therapy. Subsequently, the recommended weekly dose is 250 mg/m² over a 1-hour period for the remaining duration of radiation therapy (6 to 7 weeks). Erbitux administration should be completed 1 hour prior to radiation. Maximum infusion rate is 10mg per minute.

Recommended Premedication

Premedicate with an H-1 antagonist (such as 50mg of diphenhydramine) intravenously 30 to 60 minutes prior to the first dose of Erbitux. Pre-medication should be administered subsequently based on your doctor's judgment and the presence or severity or previous infusion reactions.

How should I take Erbitux?

Erbitux should be administered weekly in a hospital setting. Erbitux is a drug that is intravenously given to a patient.

Do not use Erbitux if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.

Do not shake or dilute Erbitux.

When on Erbitux therapy, always use adequate contraception (such as a condom) when having sex. Do this for as long as you take Erbitux and for 6 months after your last dose of this medication. (This applies to both males and females who are on Erbitux therapy.)

Nursing is not recommended during Erbitux therapy and for at least 2 months following the last dose of this medication.

What should I avoid while taking Erbitux?

Do not drive or perform other possibly unsafe tasks until you know how you react to Erbitux; this drug may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines.

Avoid the sun, sunlamps, or tanning booths until you know how you react to Erbitux. Erbitux may cause you to become sunburned more easily. If you must be outside for more than a short time, use sunscreen or wear protective clothing while you use Erbitux and for 2 months after your last dose.

Avoid contact with people who have colds or infections. Erbitux may lower the ability of your body to fight infection.

Do not use Erbitux if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.

What are possible food and drug interactions associated with Erbitux?

If Erbitux is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Erbitux with vitamins, prescription, herbal, and over-the-counter medications.

What are the possible side effects of Erbitux?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

Side effects when combined with chemotherapy may include: diarrhea, nausea, Rash, stomach pain, vomiting, weakness/tiredness

Side effects when combined with radiation therapy may include: constipation, dry mouth, nausea, rash, sore throat, trouble swallowing, weakness, weight loss, vomiting

Can I receive Erbitux if I am pregnant or breastfeeding?

The effects of Erbitux during pregnancy and breastfeeding are unknown. Talk with your doctor before taking this drug if you are pregnant, plan to become pregnant, or are breastfeeding.

Nursing is not recommended during Erbitux therapy and for at least 2 months following the last dose of the drug.

What should I do if I miss a dose of Erbitux?

Ask your doctor for advice.

How should I store Erbitux?

Erbitux is usually handled and stored by a healthcare provider.