In the U.S.—

• Antineoplastic

Cetuximab ( se-TUX-i mab) is a monoclonal antibody. It is used to treat cancer of the colon and rectal area. Cetuximab interferes with the growth of cancer cells, which are then eventually destroyed by the body.

Cetuximab is to be administered only by or under the immediate supervision of your doctor. It is available in the following dosage form:

Parenteral
• Injection (U.S.)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For cetuximab, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to cetuximab. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies on effects in pregnancy have not been done in either humans or animals. However, cetuximab is related to an immunoglobulin. Immunoglobulins are involved in the baby's ability to fight infection and do cross the placenta. It is not known whether cetuximab can cause harm to the fetus, when administered to a pregnant woman. Women who are able to bear children should use some kind of birth control during treatment with cetuximab. Before receiving this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Tell your doctor right away if you think you have become pregnant while receiving cetuximab.

Breast-feeding—It is not known whether cetuximab passes into the breast milk. However, because of the possibility of serious effects, breast-feeding is not recommended while you are receiving this medicine and for a while after you stop receiving it. Discuss with your doctor the proper time to begin breast-feeding after treatment with cetuximab.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of cetuximab in children with use in other age groups.

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Fibrotic lung disease, pre-existing—May be worsened by cetuximab

• Radiation therapy—may increase your chance of getting severe skin reactions.

Dosing—

The dose of cetuximab will be different for different patients. The dose that is used may depend on a number of things, including what the medicine is being used for, the patients size, and whether or not other medications are also being given. Cetuximab is usually given by a doctor or a nurse in the hospital or an outpatient clinic. If you have any questions about the proper dose of cetuximab, ask your doctor.

It is very important that your doctor check you at regular visits.

Avoid over exposing your skin to sunlight. Regularly use sunscreen or sun blocking lotions. Also, wear protective clothing and hats.

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 immediately if any of the following side effects occur:

• More common
  • Blemishes on the skin, pimples;  bloating or swelling of face, arms, hands, lower legs, or feet;  chills;  cough or hoarseness;  difficult or labored breathing;  dizziness;  facial swelling;  fever;  headache;  lower back or side pain;  nausea;  painful or difficult urination ;  pale skin;  rapid weight gain;  shortness of breath;  skin rash;  tightness in chest;  tingling of hands or feet;  troubled breathing with exertion;  unusual bleeding or bruising;  unusual tiredness or weakness;  unusual weight gain or loss;  vomiting;  weakness;  wheezing 
  
  

• Less common or rare
  • Anxiety;  black, tarry stools;  chest pain;  confusion;  decreased urination;  dry mouth;  fainting;  fast heartbeat;  increase in heart rate;  kidney failure ;  lightheadedness;  rapid, shallow breathing;  sore throat;  sores, ulcers, or white spots on lips or in mouth;  sunken eyes;  swollen glands;  thirst;  wrinkled skin 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome.

• More Common
  • Acid or sour stomach;  back pain;  belching;  burning, dry or itching eyes ;  diarrhea;  difficulty having a bowel movement (stool);  discharge from eye;  discoloration of fingernails or toenails;  discouragement;  excessive tearing;  feeling sad or empty;  hair loss, thinning of hair ;  heartburn;  indigestion ;  irritability;  itching skin;  lack or loss of appetite;  lack or loss of strength;  loss of interest or pleasure ;  pain;  redness, pain, swelling of eye, eyelid, or inner lining of eyelid;  stomach discomfort upset or pain;  sleeplessness;  stomach pain;  swelling or inflammation of the mouth;  trouble concentrating;  trouble sleeping;  unable to sleep 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.