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Cetuximab

(set-tuk-sih-mab)

Trade/other name(s): Erbitux

Why would this drug be used?

This drug is used to treat head and neck cancers. It’s also used for colorectal cancers that have special genetic markers (see “How does this drug work?”). Cetuximab is being studied for use in other conditions as well.

How does this drug work?

Cetuximab is a type of immunotherapy known as a monoclonal antibody. A monoclonal antibody is a man-made version of an immune system protein that fits like a lock and key with one certain protein.

Cetuximab is designed to seek out and lock onto a protein called epidermal growth factor receptor (EGFR), which is located on certain cells in the body. Some cancers have higher than normal numbers of these receptors on their surfaces. Once cetuximab attaches to these cells, it brings in other immune cells to help kill them.

In colorectal cancer, this drug does not work if the cancer cells have a mutation in the KRAS gene. Your doctor will test your cancer cells to be sure the cells are KRAS mutation-negative (they do not have this mutation) before starting treatment with this drug.

Before taking this medicine

Tell your doctor…

  • If you are allergic to anything, including medicines, dyes, additives, or foods.
  • If you have any medical conditions such as kidney disease, liver disease (including hepatitis), heart disease, congestive heart failure, lung disease, diabetes, gout, or infections. These conditions may require that your medicine dose, regimen, or timing be changed.
  • If you are pregnant, trying to get pregnant, or if there is any chance of pregnancy. It is not known if this drug might cause problems if either the male or female is taking it at the time of conception or during pregnancy. Avoid pregnancy during treatment and for 6 months after treatment is given. Check with your doctor about what kinds of birth control can be used with this medicine.
  • If you are breast-feeding. While no studies have been done, this drug may pass into breast milk and affect the baby. Women should avoid breast-feeding during treatment and for 60 days after receiving the last does of cetuximab.
  • If you think you might want to have children in the future. It is not known whether or not this drug can affect fertility. Talk with your doctor about the possible risk with this drug and the options that may preserve your ability to have children.
  • About any other prescription or over-the-counter medicines you are taking, including vitamins and herbs. In fact, keeping a written list of each of these medicines (including the doses of each and when you take them) with you in case of emergency may help prevent complications if you get sick.

Interactions with other drugs

People who get the chemotherapy drugs cisplatin or carboplatin while taking this drug are more likely to have serious heart problems, which in some cases might be fatal. This risk is rare, but it might be higher in people who had heart disease before treatment.

No other serious interactions are known at this time, but this does not necessarily mean that none exist. Check with your doctor, nurse, or pharmacist about your other medicines, herbs, and supplements, and whether alcohol can cause problems with this medicine.

Interactions with foods

No serious interactions with food are known at this time. Check with your doctor, nurse, or pharmacist about whether some foods may be a problem.

Tell all the doctors, dentists, nurses, and pharmacists you visit that you are taking this drug.

How is this drug taken or given?

Cetuximab is given by infusion into a vein, usually once a week. The first dose is usually given over 2 hours. Later treatments are given over 1 hour if you have had no problems with them, but they may take longer if you have any symptoms of an infusion reaction. You will likely be given another medicine before each infusion to lessen the chance you might have a reaction. The total dose depends on your body size.

Precautions

This drug can cause infusion reactions in some people, especially with the first treatment. Mild reactions usually consist of fever and chills. More serious reactions happen rarely, but can be dangerous. Symptoms can include feeling lightheaded or dizzy (due to low blood pressure), fever or chills, hives, nausea, itching, headache, hoarseness, coughing, shortness of breath, tightness in the throat, or swelling of the face, mouth, tongue, or eyes. Tell your doctor or nurse right away if you notice any of these symptoms during or after being given the drug. Your doctor or nurse will likely give you medicine beforehand to try to prevent an infusion reaction. If you develop serious symptoms, treatment with this drug may need to be stopped.

A rash on the face, neck, and trunk often starts during the first 2 weeks of treatment and goes away after treatment is stopped. The rash can look like acne, and cause infections, abscesses, or dry, cracking skin. It can also affect nails, eyelids, and the eyes themselves. Tell your doctor if it starts to bother you or if it starts looking infected. Sunlight can make the rash worse. Protect your skin with clothes, sunscreen, and hats, and limit your sun exposure while getting this drug and for 2 months after treatment.

In rare cases, patients with head and neck cancer who received this drug along with the chemotherapy drugs cisplatin or carboplatin or with radiation therapy have developed serious or fatal heart problems soon after treatment. Tell your doctor if you have had any heart problems before starting treatment. He or she will likely order blood tests during and after treatment to look at your body’s mineral (electrolyte) levels. Possible symptoms of heart problems might include chest pain, increased coughing, trouble breathing (especially at night), or swelling in the ankles or legs. Tell your doctor right away if you start to notice any of these symptoms once treatment begins.

In rare cases, patients have developed severe lung disease during treatment. Tell your doctor right away if you notice any possible symptoms of lung problems, such as shortness of breath.

This drug can cause low blood levels of magnesium. This can affect the heart and also cause the levels of other electrolytes (like potassium and calcium) to become low, which can cause more problems. Your doctor will test your blood throughout your treatment, looking for possible effects of the drug on your kidney function and the levels of calcium, magnesium, and potassium. Based on the test results, you may be given medicines to help treat any effects. Your doctor may also need to reduce or delay your next dose of this drug, or even stop it altogether. Keep all your appointments for lab tests and doctor visits.

This drug may lower your red blood cell count. If this occurs, it will usually happen a few weeks after starting treatment. A low red blood cell count (known as anemia) can cause shortness of breath, or make you feel weak or tired all the time. Your doctor will check your blood counts to watch for this and may give you medicines to help prevent or treat this condition, or you may need to get blood transfusions.

This drug can cause a rash in any area of the body where you’ve gotten radiation treatment (radiation recall). The rash can range from mildly red to breaks in the skin and bleeding. Let your doctor know if this happens.

Both men and women should avoid conceiving a child for 6 months after treatment in order to prevent harm to the fetus. Talk with your doctor about what kind of birth control you can use with this medicine.

Possible side effects

You will probably not have most of the following side effects, but if you have any talk to your doctor or nurse. They can help you understand the side effects and cope with them.

Common

  • Acne-like rash on face, neck, and trunk*
  • Itching
  • Changes in fingernails and toenails*
  • Infections
  • Mouth sores
  • Feeling tired and weak
  • Low blood mineral (electrolyte) levels*

Less common

  • Infusion reaction (may include fever, headache, chills, itching, hives, nausea, shortness of breath)*
  • Fever
  • Cough
  • Headache
  • Nausea
  • Vomiting
  • Diarrhea
  • Loss of appetite
  • Dehydration
  • Weight loss
  • Constipation
  • Abdominal (belly) pain
  • Swelling of feet
  • Trouble sleeping

Rare

  • Serious infusion reactions with trouble breathing, swelling of the mouth or face, tightness in the throat, faintness, shock, heart attack, cardiac arrest*
  • Damage to the heart (may cause chest pain, coughing, trouble breathing, swelling in legs or ankles, heart attack, or even death)*
  • Damage to the lungs*
  • Low red blood cell counts (anemia)*
  • Damage to the kidneys
  • Confusion
  • Anxiety or depression
  • Mouth sores
  • Damage to the corneas (clear parts of the eyes)
  • Heartburn
  • Back pain
  • Death due to infusion reactions, infection, heart problems, lung disease, abnormal blood levels of electrolytes, or other causes

*See “Precautions” section for more detailed information.

There are other side effects not listed above that can also occur in some patients. Tell your doctor or nurse if you develop these or any other problems.

FDA approval

Yes – first approved in 2004

Disclaimer: This information does not cover all possible uses, actions, precautions, side effects, or interactions. It is not intended as medical advice, and should not be relied upon as a substitute for talking with your doctor, who is familiar with your medical needs.

Last Medical Review: 04/30/2013
Last Revised: 04/30/2013