erbitux

Erbitux (cetuximab) is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Erbitux is used to treat cancers of the colon and rectum. It is also used to treat head and neck cancer.

Erbitux is often used in combination with other cancer medicines or radiation treatment.

Important information

Erbitux is often used in combination with other cancer medications and/or radiation treatments.

Before receiving Erbitux, tell your doctor if you have heart rhythm problems, congestive heart failure, breathing problems, coronary artery disease, or low levels of potassium or magnesium in your blood.

Some people receiving a this medicine have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, feverish, itchy, or short of breath during the injection.

Cetuximab has caused life-threatening side effects in a small number of patients. Your caregivers will watch you closely after you receive each dose of this medicine.

Avoid exposure to sunlight or tanning beds while you are receiving this medicine and for at least 2 months after your treatment ends. Erbitux can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Erbitux can have long lasting effects on your body. You may need frequent medical tests for a short time after you stop using this medicine.

Before taking this medicine

You should not use Erbitux if you are allergic to cetuximab or to mouse protein.

To make sure Erbitux is safe for you, tell your doctor if you have:

• heart rhythm problems;

• lung disease or a breathing disorder;

• congestive heart failure;

• coronary artery disease (clogged arteries); or

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Whether you are a man or a woman, use effective birth control to prevent pregnancy while you are receiving Erbitux, and for at least 6 months after your treatment ends.

You should not breast-feed a baby while you are receiving Erbitux and for at least 60 days after your treatment ends. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

How is Erbitux given?

Erbitux is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. The injection must be given slowly, and the IV infusion can take up to 2 hours to complete. You may be given other medications to prevent certain side effects while you are receiving cetuximab.

Erbitux is usually given once every week for 6 to 7 weeks or until your body no longer responds to the medication. Follow your doctor"s dosing instructions very carefully.

Erbitux is often used in combination with other cancer medications and/or radiation treatments. You may receive another cancer medicine 1 hour after your cetuximab injection.

If you are also being treated with radiation, you will receive your first Erbitux injection 1 week before your radiation treatment. Later doses are usually given 1 hour before radiation treatments.

Cetuximab has caused life-threatening side effects in a small number of patients. After each infusion, your caregivers will watch you closely to make sure you do not have any serious side effects.

To make sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

Erbitux can have long lasting effects on your body. You may need to have blood tests for several weeks after your Erbitux treatment has ended. Do not miss any follow-up visits to your doctor.

Erbitux dosing information

Usual Adult Dose for Colorectal Cancer:

Initial Dose: 400 mg/m2 administered as a 2 hour intravenous infusion (maximum infusion rate 5 mL/min)

Maintenance Dose: 250 mg/m2 infused over 1 hour (maximum infusion rate 5 mL/min) once a week

If given in combination with FOLFIRI, the Erbitux infusion should be completed one hour prior to FOLFIRI.

Usual Adult Dose for Squamous Cell Carcinoma:

Note: In combination with radiation therapy, Erbitux is approved by the FDA for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck. In combination with platinum based therapy with 5-FU, Erbitux is indicated for the first-line treatment of patients with recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck. As a single agent, Erbitux is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck for whom prior platinum based therapy has failed.

As a Part of Combination Therapy:
Initial Loading Dose: 400 mg/m2 as a 120 minute intravenous infusion (maximum infusion rate 5 mL/min) one week prior to initiation of a course of radiation therapy or on the day of initiation of platinum based therapy with 5-FU.
Weekly Maintenance Dose: 250 mg/m2 infused over 60 minutes (maximum infusion rate 5 mL/min) weekly for the duration of radiation therapy (6 to 7 weeks) or until disease progression or unacceptable toxicity when administered in combination with platinum based therapy with 5-FU. Complete Erbitux administration 1 hour prior to radiation therapy or platinum based therapy with 5-FU.

Single Agent Therapy:
Initial Dose: 400 mg/m2 as a 120 minute intravenous infusion.
Weekly Maintenance Dose: 250 mg/m2, as a 60 minute intravenous infusion, weekly until disease progression or unacceptable toxicity occurs.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Erbitux infusion.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving Erbitux?

Avoid exposure to sunlight or tanning beds while you are receiving Erbitux and for at least 2 months after your treatment ends. Erbitux can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Erbitux side effects

Get emergency medical help if you have signs of an allergic reaction to Erbitux: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people receiving a Erbitux injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel short of breath, weak or dizzy, nauseated, itchy, or have wheezing, noisy breathing, or a hoarse voice during the injection.

Call your doctor at once if you have:

• an acne-like skin rash or any severe skin rash;

• redness, swelling, or puffiness under your skin;

• eye pain or redness, puffy eyelids, drainage or crusting in your eyes, vision problems, or increased sensitivity to light;

• sudden chest pain or discomfort, wheezing, dry cough, feeling short of breath, coughing up blood;

• chest pain spreading to your jaw or shoulder;

• a light-headed feeling, like you might pass out, slow heart rate, weak pulse, slow breathing;

• symptoms of infection--fever, flu symptoms, mouth and throat ulcers, rapid heart rate, rapid and shallow breathing, fainting;

• symptoms of an electrolyte imbalance--leg cramps, constipation, irregular heartbeats, fluttering in your chest, extreme thirst, numbness or tingling, vision problems, muscle pain or weakness;

• kidney problems--little or no urinating; painful or difficult urination; swelling in your feet or ankles; or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Erbitux side effects may include:

• mild itching or rash;

• changes in your fingernails or toenails;

• dry, cracked, or swollen skin;

• headache;

• diarrhea; or

• infection.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Erbitux?

There may be other drugs that can interact with cetuximab. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.