Erbitux 100 mg/50 mL intravenous solution

Generic name:
Cetuximab - injection

Pronunciation
(se-TUX-i-mab)

Brand name(s)
Erbitux

Severe (sometimes fatal) reactions have occurred in people while receiving cetuximab. Your risk may be higher if you have a history of tick bites or have a severe allergic reaction to meat (such as beef, pork). Before receiving cetuximab, tell your doctor if you have either of these conditions. Your doctor will carefully monitor you during and for at least one hour after your infusion. Tell your doctor right away if you have shortness of breath, hoarseness, itching, or dizziness. Your doctor may stop treatment with this medication if you have a severe reaction.

Rare deaths due to heart problems (cardiopulmonary arrest) or sudden death have occurred in people with head and neck cancer treated with cetuximab. Before starting treatment with this medication, tell your doctor if you have a history of heart disease (such as heart failure, irregular heartbeat, previous heart attack). Get medical help right away if you develop chest/jaw/left arm pain, shortness of breath, or unusual sweating. Your doctor will order certain blood tests (including magnesium, calcium, and potassium) during and after your treatment to monitor and help decrease your risk for heart problems.

Cetuximab is used to treat a certain type of cancer of the colon (large intestine) or rectum. This medication is also used to treat head and neck cancer. Cetuximab works by slowing or stopping the growth of cancer cells. It binds to a certain protein (epidermal growth factor receptor-EGFR) in some tumors. Cetuximab is a man-made protein (monoclonal antibody).

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Cetuximab may also be used for kidney cancer.

Cetuximab is given by injection into a vein as directed by your doctor, usually once every week or every 2 weeks by a healthcare professional. Another drug (such as diphenhydramine) may be given before you receive cetuximab to lessen the chance of certain side effects. The dosage is based on your medical condition, body size, and response to treatment.

A healthcare professional should watch you for at least 1 hour after your infusion is finished to make sure you do not have an infusion reaction. (See Warning section). If you experience a severe infusion reaction, your infusion will be stopped and your doctor may decide to stop further treatments.

See also Warning section.

Nausea, vomiting, constipation, diarrhea, headache, stomachache, backache, fever/chills, trouble sleeping, weight loss, tiredness, drowsiness, eye redness/itching, nail changes, dry skin, and mouth/throat sores may occur. Nausea and vomiting can be quite severe. In some cases, drug therapy may be necessary to prevent or relieve nausea and vomiting. Not eating before your treatment may help relieve vomiting. Changes in diet such as eating several small meals or limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

An acne-like rash may occur. Depending on how severe this rash is, your doctor may delay your cetuximab treatment, lower your dose, treat the rash with antibiotics, or stop treatment with cetuximab to decrease this potentially serious side effect.

Tell your doctor right away if you have any serious side effects, including:

• mental/mood changes (such as confusion, depression)
• swelling of hands/feet/lower legs
• signs of dehydration (such as unusual dry mouth/thirst, dizziness/lightheadedness)
• signs of serious infection (such as sore throat that doesn't go away, high fever, chills)
• signs of kidney problems (such as change in the amount of urine)
• decreased vision
• fast/slow/irregular heartbeat
• muscle spasms

Rarely, very serious lung problems may occur. Get medical help right away if you develop:

• trouble breathing
• chest pain

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before receiving cetuximab, tell your doctor or pharmacist if you are allergic to it, or if you have a severe allergy to meat (such as beef, pork), or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• lung disease
• radiation therapy
• heart disease (such as coronary artery disease, heart failure, arrhythmias)
• tick bites

This drug may make you drowsy. Alcohol or marijuana (cannabis) can make you more drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Sunlight may worsen any skin reactions that may occur while you are using this drug. Avoid prolonged sun exposure, tanning booths, and sunlamps during treatment and for 2 months after your last treatment with cetuximab. Use a sunscreen and wear protective clothing when outdoors.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using cetuximab. Cetuximab may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 2 months after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

Based on information from related drugs, cetuximab may pass into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using cetuximab and for 2 months after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as calcium, magnesium, potassium levels) should be done while you are using this medication and for up to 8 weeks after your last infusion. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of cetuximab as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.