Erbitux

Erbitux is given with radiation treatment and other medicines to treat cancer in the colon and rectal area, and cancer in the head and neck area. This medicine is usually given to patients who have already received other cancer treatments. Cetuximab should only be used in patients with metastatic (cancer that spreads to other parts of the body) colon or rectal cancer who have had a KRAS gene mutation test. This test helps the doctor decide whether the medicine will treat their cancer.

Cetuximab interferes with the growth of cancer cells, which are then destroyed by the body. Since the growth of normal body cells may also be affected by cetuximab, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, such as a skin rash, may not be serious but may cause concern. Some effects do not occur until months or years after the medicine is used.

Before you begin treatment with cetuximab, you and your doctor should talk about the benefits this medicine will do as well as the risks of using it. This medicine will only be given by or under the immediate supervision of your doctor. This product is available in the following dosage forms:

• Solution

Before using Erbitux, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

• Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
• Pediatric population: Appropriate studies have not been performed on the relationship of age to the effects of cetuximab injection in the pediatric population. Safety and efficacy have not been established.
• Geriatric Population: Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cetuximab injection in the elderly.
• Pregnancy: All Trimesters. Category C: Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
• Breastfeeding: There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
• Drug Interactions: 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 healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
• Other Interactions: Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
• Other Medical Problems: The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
  • Congestive heart failure, history of or
  • Coronary artery disease, history of or
  • Heart rhythm problems—May increase your risk of having serious side effects.
  • Fibrotic lung disease, history of or
  • Hypocalcemia (low calcium in the blood)
  • Hypokalemia (low potassium in the blood)
  • Hypomagnesemia (low magnesium in the blood)—Use with caution. May make these conditions worse.

To use Erbitux correctly, you must follow all instructions given by your doctor.

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. This medicine is given through a needle placed in one of your veins. Cetuximab needs to be given slowly, so the needle will remain in place for at least an hour. The first dose of this medicine could take 2 hours to give.

You may also receive medicines (e.g., diphenhydramine) to help prevent possible allergic reactions to the injection. This medicine sometimes causes nausea and vomiting. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. Ask your doctor for ways to lessen these effects.

As with many medications, there are several potential side effects associated with Erbitux.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Cetuximab may cause a serious side effect called an infusion reaction. This can be life-threatening and require immediate medical attention. Tell your doctor or nurse right away if you have a fever, chills, trouble with breathing, lightheadedness, fainting, or chest pain within a few hours after you receive it.

Tell your doctor or nurse right away if you are having shortness of breath, cough, difficulty with breathing, or other breathing problems while being treated with this medicine. These may be symptoms of a serious lung problem. Serious skin reactions can occur with this medicine. Check with your doctor right away if you have:

• Blistering, Peeling, or Loosening of the skin
• Dry skin
• Grooves or Lines in the skin
• Red skin lesions
• Severe acne or skin rash
• Sores or Ulcers on the skin
• Fever or Chills while you are using this medicine

This medicine may make your skin more sensitive to sunlight. Use a sunscreen or sun-blocking lotion when you are outdoors. Wear protective clothing and hats. Avoid sunlamps and tanning beds.

Along with its needed effects, Erbitux 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 or nurse immediately if any of the following side effects occur:

More common:

• Blemishes on the skin or pimples
• Bloating or Swelling of the face, arms, hands, lower legs, or feet
• Body aches or pain
• Chills
• Congestion
• Cough or Hoarseness
• Deep cracks, grooves, or lines in the skin
• Difficult or labored breathing
• Dizziness
• Facial swelling
• Fever
• Headache
• Lower back or side pain
• Nausea
• Painful or Difficult urination
• Pale skin
• Rapid weight gain
• Runny nose
• Severe dry skin
• Shortness of breath
• Skin rash
• Tender, Swollen glands in the neck
• Tightness in the chest
• Tingling of the hands or feet
• Trouble with breathing on exertion
• Trouble with swallowing
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Unusual weight gain or loss
• Voice changes
• 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
• Lightheadedness
• Rapid, shallow breathing
• Sore throat
• Sores, Ulcers, or White spots on the lips or in the mouth
• Sunken eyes
• Swollen glands
• Thirst
• Wrinkled skin

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common:

• Acid or sour stomach
• Belching
• Burning, Dry, or Itching eyes
• Diarrhea
• Difficulty having a bowel movement (stool)
• Discharge from the eye
• Discoloration of the fingernails or toenails
• Discouragement
• Excessive tearing
• Feeling sad or empty
• Hair loss or thinning of the hair
• Heartburn
• Indigestion
• Irritability
• Itching skin
• Lack or Loss of appetite
• Lack or Loss of strength
• Loss of interest or pleasure
• Pain
• Redness, Pain, or Swelling of the eye, eyelid, or inner lining of the eyelid
• Sleeplessness
• Stomach discomfort, upset, or pain
• Swelling or inflammation of the mouth
• Trouble concentrating
• Trouble sleeping
• Unable to sleep

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.