Cetuximab (se-TUX-i-mab)

Treats cancer, including head, neck, and colorectal cancer.

Brand Name(s):

Erbitux

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. This medicine needs to be given slowly, so the needle will have to remain in place for at least 1 hour. The first dose of this medicine could take 2 hours to give.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• You may also receive other medicines (including allergy medicine) to prevent unwanted effects to the injection.
• Your doctor may need you to stay in the hospital or cancer treatment center for at least 1 hour after you have received the medicine. You might need to stay longer if you have any signs of an allergic reaction.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how cetuximab works. Tell your doctor if you are receiving cisplatin or radiation treatment.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment with this medicine and for at least 2 months after the last dose.
• Do not breastfeed during treatment and for at least 2 months after the last dose.
• Tell your doctor if you have heart or blood vessel disease, heart failure, heart rhythm problems, lung disease, or a history of tick bites or red meat allergy.
• This medicine can cause the following problems:
  • Infusion reaction
  • Lung or breathing problems, including interstitial lung disease
  • Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Some women who use this medicine have become infertile (unable to have children). Talk with your doctor before receiving this medicine if you plan to have children.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds. Limit your time in the sun during treatment and for at least 2 months after the last dose.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blemishes on the skin, pimples
• Blistering, peeling, red skin rash
• Change in how much or how often you urinate
• Chest pain, coughing up blood
• Dry mouth, increased thirst, muscle cramps
• Headache, bone pain, back pain
• Lightheadedness, fainting
• Nausea, vomiting, diarrhea, constipation, loss of appetite, or stomach pain
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• Sores or white patches on your lips, mouth, or throat
• Swelling in your hands, ankles, or feet
• Trouble breathing or swallowing
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Anxiety, confusion, trouble sleeping
• Discoloration of the fingernails or toenails
• Eye or vision changes
• Pain in the arms or legs

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088