Cetuximab - Injection

Pronunciation: se-TUX-i-mab

Common Brand Name(s): Erbitux

Important: 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.

Warning

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.

Uses

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).

Other Uses

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.

How To Use

Cetuximab is given by injection into a vein usually once a week by a healthcare professional. Another drug (e.g., diphenhydramine) may be given before you receive cetuximab to lessen the chance of certain side effects. The first dose (loading dose) is larger and is given over 2 hours. All other doses (maintenance doses) are smaller and are given over 1 hour if tolerated. 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.

Side Effects

See also Warning section.

Nausea, vomiting, constipation, diarrhea, headache, stomachache, backache, fever/chills, trouble sleeping, weight loss, fatigue, 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, your doctor has prescribed this drug because he or she 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:

  • confusion
  • depression
  • swelling of hands/feet/lower legs
  • dehydration
  • signs of serious infection (such as high fever, chills, persistent sore throat)
  • signs of kidney problems (such as change in the amount of urine)
  • decreased vision
  • severe dizziness
  • fast/slow/irregular heartbeat
  • severe 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.

Precautions

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 (e.g., coronary artery disease, congestive 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.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss the use of reliable forms of birth control (such as condoms, birth control pills) while using this medication and for 2 months after the end of treatment.

Based on information from related drugs, cetuximab may pass into breast milk. Because of potential harm to the infant, breast-feeding is not recommended while using cetuximab and for 2 months after the end of treatment. Consult your doctor before breast-feeding.

Drug Interactions

Your healthcare professionals (such as your doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Overdose

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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Medical tests and regular physical exams should be performed to check for side effects. Laboratory tests should be performed before giving cetuximab to check for the EGFR protein on your tumor. Certain laboratory tests (e.g., calcium, magnesium, potassium levels) will be performed from time to time while you are being treated with cetuximab and up to 8 weeks after your last infusion. Consult your doctor for more details. Keep all scheduled medical appointments.

Missed Dose

It is important that you receive cetuximab as scheduled by your doctor. If you miss a dose, contact your doctor right away to obtain a new dosing schedule.

Storage

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

Is it an emergency?

If you or someone in your care has chest pains, difficulty breathing, or severe bleeding, it could be a life-threatening emergency. Call 9-1-1 or the local emergency number immediately.
If you are concerned about a possible poisoning or exposure to a toxic substance, call Poison Control now at 1-800-567-8911.

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