Cetuximab Injection

IMPORTANT WARNING:

Cetuximab may cause severe or life-threatening reactions while you receive the medication. These reactions are more common with the first dose of cetuximab but may occur at any time during treatment. Your doctor will watch you carefully while you receive each dose of cetuximab and for at least 1 hour afterward. Tell your doctor if you are allergic to red meat, or if you have ever been bitten by a tick. If you experience any of the following symptoms during or after your infusion tell your doctor immediately: sudden difficulty breathing, shortness of breath, wheezing or noisy breathing, swelling of the eyes, face, mouth, lips or throat, hoarseness, hives, fainting, dizziness, nausea, fever, chills, or chest pain or pressure. If you experience any of these symptoms your doctor may slow down or stop your infusion and treat the symptoms of the reaction. You may not be able to receive treatment with cetuximab in the future.

People with a head and neck cancer who are treated with radiation therapy and cetuximab may have an increased risk of cardiopulmonary arrest (condition in which the heart stops beating and breathing stops) and sudden death during or after their treatment. Tell your doctor if you have or have ever had coronary artery disease (condition that occurs when the blood vessels of the heart are narrowed or clogged by fat or cholesterol deposits); heart failure (condition in which the heart is unable to pump enough blood to the other parts of the body); irregular heartbeat; other heart disease; or lower than normal levels of magnesium, potassium, or calcium in your blood.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests during and after your treatment to check your body's response to cetuximab.

Talk to your doctor about the risks of using cetuximab.

WHY is this medicine prescribed?

Cetuximab is used with or without radiation therapy to treat a certain type of cancer of the head and neck that has spread to nearby tissues or other parts of the body. It can also be used with other medications to treat a certain type of head and neck cancer that has spread to other parts of the body or keeps coming back after treatment. Cetuximab is also used alone or in combination with other medications to treat a certain type of cancer of the colon (large intestine) or rectum that has spread to other parts of the body. Cetuximab is in a class of medications called monoclonal antibodies. It works by slowing or stopping the growth of cancer cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Cetuximab comes as a solution (liquid) to be infused (injected slowly) into a vein. Cetuximab is given by a doctor or nurse in a medical office or infusion center. The first time you receive cetuximab, it will be infused over a period of 2 hours, then the following doses will be infused over 1 hour. Cetuximab is usually given every 1 to 2 weeks for as long as your doctor recommends that you receive treatment.

Your doctor may need to slow down your infusion, reduce your dosage, delay or stop your treatment, or treat you with other medications if you experience certain side effects. Be sure to tell your doctor how you are feeling during your treatment with cetuximab.

What SPECIAL PRECAUTIONS should I follow?

Before receiving treatment with cetuximab,

• tell your doctor and pharmacist if you are allergic to cetuximab, any other medications, red meat, or galactose, or to any of the ingredients in cetuximab. Ask your pharmacist for a list of the ingredients. Also, tell your doctor and pharmacist if you have have or have had tick bites.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

• tell your doctor if you have or have ever had heart disease.

• tell your doctor if you are pregnant or plan to become pregnant. You will have to take a pregnancy test before starting treatment. You should not become pregnant during your treatment with cetuximab and for at least 2 months after your final dose. Talk to your doctor about birth control methods that you can use during your treatment. If you become pregnant while you are receiving cetuximab, call your doctor.

• tell your doctor if you are breastfeeding. Your doctor may tell you not to breastfeed during your treatment and for 2 months after your final dose.

• you should know that this medication may decrease fertility in women. Talk to your doctor about the risks of receiving cetuximab.

• plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, a hat, sunglasses, and sunscreen during your treatment with cetuximab and for 2 months after your treatment.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss an appointment to receive a dose of cetuximab, call your doctor right away.

What SIDE EFFECTS can this medicine cause?

Cetuximab may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• acne-like rash
• dry or cracking skin
• itching
• swelling, pain, or changes in the fingernails or toenails
• red, watery, or itchy eye(s)
• red or swollen eyelid(s)
• pain or burning sensation in eye(s)
• sensitivity of eyes to light
• hair loss
• increased hair growth on head, face, eyelashes, or chest
• chapped lips
• headache
• tiredness
• weakness
• confusion
• numbness, tingling, pain, or burning in arms or legs
• dry mouth
• sores on lips, mouth, or throat
• sore throat
• nausea
• vomiting
• change in ability to taste food
• loss of appetite
• weight loss
• constipation
• diarrhea
• heartburn
• joint pain
• bone pain
• pain, redness, or swelling at the place the medication was injected

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• loss of vision
• blistering, peeling, or shedding skin
• red, swollen, or infected skin
• new or worsening cough, shortness of breath, or chest pain

Cetuximab may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Ask your doctor if you have any questions about your treatment with cetuximab.

For some conditions, your doctor will order a lab test before you begin your treatment to see whether your cancer can be treated with cetuximab.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.