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Erbitux Warnings and Precautions

During treatment with Erbitux, certain precautions will be taken to prevent infusion reactions; for example, you may be given drugs prior to each dose. You will also be monitored carefully during the injection process. Difficulty breathing, chest pain, and nausea are warnings signs of potentially serious problems with Erbitux and need to be reported to your healthcare provider.

What Should I Tell My Healthcare Provider?

Talk with your healthcare provider prior to using Erbitux® (cetuximab) if you have:
 
  • Heart problems, including heart disease, heart failure, or an abnormal heart rhythm (arrhythmia)
  • Ever been told you have electrolyte abnormalities, such as low calcium, potassium, or magnesium blood levels
  • Frequent sun exposure
  • Lung disease or a history of lung disease
  • Any allergies, including to foods, dyes, or preservatives.
     
Also, let your healthcare provider know if you are:
 
  • Breastfeeding
  • Pregnant or thinking of becoming pregnant.
     
Make sure to tell your healthcare provider about any medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.
 

Specific Precautions and Warnings With Erbitux

Some warnings and precautions to be aware of prior to using this medication include the following:
 
  • There were rare reports of heart attack and death in people using Erbitux in clinical trials. Some of the deaths occurred over a month after the final dose was given. Let your healthcare provider know if you have a history of heart disease or heart rhythm problems. Seek immediate medical attention if you develop signs of a heart attack, such as:
     
    • Itching
    • Chest discomfort, pain, or pressure
    • Trouble breathing or shortness of breath
    • A hoarse voice
    • Cold sweats
    • Dizziness
    • Nausea.
 
  • Erbitux may cause serious skin reactions, including:
     
    • An acne-type rash
    • Dry and cracking skin
    • Infection
    • Abnormal hair growth
    • A nail disorder that causes pain and swelling of the skin around the toenails or fingernails.

 

    Sun exposure may make these reactions worse. Plan to limit your time in the sun during treatment and for at least two months after your last dose, and wear protective clothing and sunscreen when you go outside. Also, tell your healthcare provider if you develop any skin problems during Erbitux treatment.
 
  • There have been rare reports of serious lung disease in people receiving Erbitux. Let your healthcare provider know if you have any difficulty breathing, such as shortness of breath. Your healthcare provider may recommend you stop treatment.
     
  • It is not known whether Erbitux is safe when used in combination with radiation therapy and cisplatin (a chemotherapy medicine). There were reports of death and serious heart problems in people with head and neck cancer who received this combination in clinical studies.
     
  • Some people may have a severe allergic reaction to this product. These reactions are most likely to occur during the first dose, but can happen anytime. To help reduce the likelihood that you will have an allergic reaction, your healthcare provider may give you a medicine before you receive Erbitux. Your healthcare provider will also observe you carefully for an allergic reaction while you receive the drug and for at least an hour after your dose.

Let your healthcare provider know immediately if you experience any of the following symptoms:

    • A skin rash or hives
    • Chest pain or tightness
    • Difficulty breathing, wheezing, or a feeling of tightness in your throat
    • Dizziness
    • Chills
    • Shaking
    • Sweating.
 
  • You may develop low blood levels of calcium, magnesium, or potassium during treatment. Your healthcare provider will periodically monitor your blood electrolytes with a simple blood test while you are receiving this drug and for at least eight weeks after your last dose. If your calcium, magnesium, or potassium levels drop too much, your healthcare provider will give you intravenous replacements to bring the levels back to normal.
     
  • Erbitux may increase the risk of late radiation side effects, which occur months after radiation treatment is complete. If you receive radiation treatment, your healthcare provider will talk to you about ways to help prevent and treat such side effects.
     
  • Based on the results of clinical trials of people with advanced colorectal cancer, this medicine may not work in people whose cancer had a change (mutation) in a gene known as the K-ras gene.
     
  • Erbitux is not likely to react with other medications (see Erbitux Drug Interactions for more information).
     
  • It is unknown if Erbitux passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to beginning treatment (see Erbitux and Breastfeeding).
     
  • This product is considered a pregnancy Category C medication. This means it may not be safe for use during pregnancy, although the full risks are unknown (see Erbitux and Pregnancy).
     
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