Saturday, September 8, 2012

cetuximab


Generic Name: cetuximab (se TUX i mab)

Brand Names: Erbitux


What is cetuximab?

Cetuximab is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.


Cetuximab is used to treat cancers of the colon and rectum. It is also used to treat head and neck cancer.


Cetuximab may also be used for purposes not listed in this medication guide.


What is the most important information I should know about cetuximab?


Cetuximab is often used in combination with other cancer medications and/or radiation treatments.


You should not use this medication if you are allergic to cetuximab or to mouse protein.

Before receiving cetuximab, tell your doctor if you have heart rhythm problems, congestive heart failure, breathing problems, coronary artery disease, or low levels of potassium or magnesium in your blood.


After your cetuximab infusion, your doctor will need to watch you for about an hour. This is to make sure you do not have any serious side effects from the medicine.

Some people receiving a cetuximab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel short of breath, weak or dizzy, nauseated, itchy, or have wheezing, noisy breathing, or a hoarse voice during the injection.


To make sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests. Do not miss any follow-up visits to your doctor. Avoid exposure to sunlight or tanning beds while you are receiving cetuximab and for at least 2 months after your treatment ends. Cetuximab can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What should I discuss with my healthcare provider before I receive cetuximab?


You should not use this medication if you are allergic to cetuximab or to mouse protein.

To make sure you can safely receive cetuximab, tell your doctor if you have any of these other conditions:



  • heart rhythm problems;




  • lung disease or a breathing disorder;




  • congestive heart failure;




  • coronary artery disease (clogged arteries); or




  • an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).




FDA pregnancy category C. It is not known whether cetuximab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Whether you are a man or a woman, use effective birth control to prevent pregnancy while you are receiving cetuximab, and for at least 6 months after your treatment ends. It is not known whether cetuximab passes into breast milk or if it could harm a nursing baby. You should not breast-feed a baby while you are receiving cetuximab and for at least 60 days after your treatment ends. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

How is cetuximab given?


Cetuximab is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Cetuximab must be given slowly, and the IV infusion can take up to 2 hours to complete. You may be given other medications to prevent certain side effects while you are receiving cetuximab.


Cetuximab is usually given once every week for 6 to 7 weeks or until your body no longer responds to the medication. Follow your doctor's dosing instructions very carefully.


Cetuximab is often used in combination with other cancer medications and/or radiation treatments. You may receive another cancer medicine 1 hour after your cetuximab injection.


After your cetuximab infusion, your doctor will need to watch you for about an hour. This is to make sure you do not have any serious side effects from the medicine.

If you are also being treated with radiation, you will receive your first cetuximab injection 1 week before your radiation treatment. Later doses are usually given 1 hour before radiation treatments.


To make sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests. Do not miss any follow-up visits to your doctor.

You may need to have blood tests for several weeks after your cetuximab treatment has ended.


What happens if I miss a dose?


Call your doctor for instructions if you miss an appointment for your cetuximab infusion.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving cetuximab?


Avoid exposure to sunlight or tanning beds while you are receiving cetuximab and for at least 2 months after your treatment ends. Cetuximab can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Cetuximab side effects


Some people receiving a cetuximab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel short of breath, weak or dizzy, nauseated, itchy, or have wheezing, noisy breathing, or a hoarse voice during the injection.


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

  • an acne-like skin rash or any severe skin rash;




  • redness, swelling, or puffiness under your skin;




  • chest tightness, dry cough, wheezing, feeling short of breath;




  • feeling like you might pass out;




  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;




  • fever, chills, flu symptoms, mouth and throat ulcers, rapid heart rate, rapid and shallow breathing;




  • feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin; or




  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop).



Less serious side effects may include:



  • dry, cracked, or swollen skin;




  • changes in your fingernails or toenails;




  • headache;




  • diarrhea;




  • mild nausea, vomiting, upset stomach;




  • sore throat;




  • weight loss; or




  • weakness.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


Cetuximab Dosing Information


Usual Adult Dose for Colorectal Cancer:

Initial Dose: 400 mg/m2 administered as a 2 hour intravenous infusion (maximum infusion rate 5 mL/min)

Maintenance Dose: 250 mg/m2 infused over 1 hour (maximum infusion rate 5 mL/min) once a week

Usual Adult Dose for Squamous Cell Carcinoma:

Note: In combination with radiation therapy, cetuximab is approved by the FDA for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck. In combination with platinum based therapy with 5-FU, cetuximab is indicated for the first-line treatment of patients with recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck. As a single agent, cetuximab is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck for whom prior platinum based therapy has failed.

As a Part of Combination Therapy:
Initial Loading Dose: 400 mg/m2 as a 120 minute intravenous infusion (maximum infusion rate 5 mL/min) one week prior to initiation of a course of radiation therapy or on the day of initiation of platinum based therapy with 5-FU.
Weekly Maintenance Dose: 250 mg/m2 infused over 60 minutes (maximum infusion rate 5 mL/min) weekly for the duration of radiation therapy (6 to 7 weeks) or until disease progression or unacceptable toxicity when administered in combination with platinum based therapy with 5-FU. Complete cetuximab administration 1 hour prior to radiation therapy or platinum based therapy with 5-FU.

Single Agent Therapy:
Initial Dose: 400 mg/m2 as a 120 minute intravenous infusion.
Weekly Maintenance Dose: 250 mg/m2, as a 60 minute intravenous infusion, weekly until disease progression or unacceptable toxicity occurs.


What other drugs will affect cetuximab?


There may be other drugs that can interact with cetuximab. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More cetuximab resources


  • Cetuximab Side Effects (in more detail)
  • Cetuximab Dosage
  • Cetuximab Use in Pregnancy & Breastfeeding
  • Cetuximab Drug Interactions
  • Cetuximab Support Group
  • 2 Reviews for Cetuximab - Add your own review/rating


  • cetuximab Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information

  • Cetuximab Professional Patient Advice (Wolters Kluwer)

  • Cetuximab MedFacts Consumer Leaflet (Wolters Kluwer)

  • Cetuximab Monograph (AHFS DI)

  • Erbitux Prescribing Information (FDA)

  • Erbitux Consumer Overview



Compare cetuximab with other medications


  • Colorectal Cancer
  • Head and Neck Cancer
  • Non-Small Cell Lung Cancer
  • Pancreatic Cancer
  • Squamous Cell Carcinoma


Where can I get more information?


  • Your doctor or pharmacist can provide more information about cetuximab.

See also: cetuximab side effects (in more detail)


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