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Cetuximab

 
Drug Info: Cetuximab
 

Brand names: Erbitux™Erbitux®



Cetuximab injection

What is Cetuximab injection?

CETUXIMAB (Erbitux™) is a monoclonal antibody. A monoclonal antibody is a protein that reacts with a specific site on a cell. Cetuximab targets a protein called epidermal growth factor receptor (EGFR). This protein is found on the surface of normal cells (such as skin cells and hair cells) and some types of cancer cells including colorectal cancer and head and neck cancer. Cetuximab works by interfering with how these tumor cells grow and causes these cells to die. Generic cetuximab injections are not available.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
• heart disease such as coronary artery disease or heart failure
• irregular heart beat or heart arrhythmia
• lung disease, especially lung fibrosis
• an unusual reaction to Cetuximab, mouse proteins, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should this medicine be used?

Cetuximab is for infusion into a vein. It is administered in a hospital or clinic setting by a health care professional. Continue a regular schedule of doses, usually given as a weekly infusion.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

It is important not to miss a dose. Notify your prescriber or health care professional if you are unable to keep an appointment.

What drug(s) may interact with Cetuximab?

There have been no drug interactions reported during cetuximab treatment.

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking Cetuximab?

During the infusion of cetuximab, you may experience changes in your breathing, fever, chills, dizziness, or lightheadedness. These effects are more common with the first infusion. If you start to experience any of these side effects, notify your health care professional right away.

In a small number of patients, cetuximab has caused or worsened lung disease. If you notice difficulty breathing, increased shortness of breath, or other changes in your breathing, notify your health care provider.

Cetuximab commonly causes skin reactions including a rash that looks like acne, skin dryness and cracking, redness, swelling and other signs of inflammation that can result in skin infections. These reactions may require treatment with antibiotics. Notify your prescriber if you notice any rash, and especially if it seems to get worse or does not get better. You should wear sunscreen and hats and limit your sun exposure (including exposure in tanning beds) while receiving cetuximab. Sunlight can worsen the skin reactions while receiving cetuximab therapy.

There is a possibility that cetuximab could cause harm to an unborn child. If you are pregnant or considering getting pregnant, talk to your health care provider about the risks of cetuximab therapy. Discuss possible methods of birth control.

Using cetuximab might cause a decrease in your bodies electrolytes, such as calcium, magnesium, and potassium. You might get regular blood tests to make sure your electrolyte levels are okay. Symptoms of decreased electrolytes are extreme tiredness or weakness and pain, tingling, or numbness of the hands or feet. If you start to experience any of these side effects, notify your health care professional right away.

What side effects may I notice from receiving Cetuximab?

The side effects you may experience depend on the dose of cetuximab, other types of chemotherapy or radiation therapy given, and the health condition being treated. Not all of the listed side effects occur in every patients. Discuss any concerns or questions with your prescriber or health care professional.

Side effects that you should report to your prescriber or health care professional as soon as possible:
• difficulty breathing or shortness of breath anytime during your treatments
• extreme tiredness or weakness
• eye inflammation
• mouth sores
• pain, tingling, or numbness of the hands or feet
• reactions during infusion of the drug (especially difficulty breathing, wheezing, shortness of breath, hives, faintness and/or dizziness)
• skin rash, redness, or severe dry skin

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
• abdominal pain
• constipation
• decreased appetite
• diarrhea
• fatigue, tiredness, or weakness
• fever, chills (usually during the infusion of the drug)
• hair loss
• headache
• heartburn or indigestion
• itching
• nausea/vomiting
• pain
• weight loss

Where can I keep my medicine?

This does not apply; you will only receive this medication in your prescriber's office or clinic.

Last updated: 7/1/2002

Important Disclaimer: The drug information provided here is for educational purposes only. It is intended to supplement, not substitute for, the diagnosis, treatment and advice of a medical professional. This drug information does not cover all possible uses, precautions, side effects and interactions. It should not be construed to indicate that this or any drug is safe for you. Consult your medical professional for guidance before using any prescription or over the counter drugs.

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Wikipedia: Cetuximab
 
Cetuximab?
Therapeutic monoclonal antibody
Source chimeric
Target EGF receptor
Identifiers
CAS number 205923-56-4
ATC code L01XC06
PubChem  ?
DrugBank BTD00071
Chemical data
Formula C6484H10042N1732O2023S36 
Mol. mass 145781.6 g/mol
Pharmacokinetic data
Bioavailability  ?
Metabolism  ?
Half life 114 hrs
Excretion  ?
Therapeutic considerations
Pregnancy cat.

?

Legal status
Routes  ?

Cetuximab (Erbitux) is a monoclonal antibody used to treat metastatic colorectal cancer and head and neck cancer.

The antibody binds to the epidermal growth factor receptor (EGFR), a signalling protein that normally controls cell division. In some cancers, this receptor is altered to cause uncontrolled cell division, a hallmark of cancer. Cetuximab blocks EGFR and stops the uncontrolled cell division.

Cetuximab is a chimeric monoclonal antibody. Most monoclonal antibodies are originally created by mouse cells, but this can cause an immune reaction to mouse proteins. Chimeric antibodies are made using parts of mouse proteins and parts of human proteins, which causes less of an immune reaction.

All monoclonal antibodies are given by intravenous therapy.

Cetuximab is marketed in North America by ImClone and Bristol-Myers Squibb, and elsewhere by Merck KGaA.

Cetuximab costs up to $30,000 for eight weeks of treatment per patient.[1]

Contents

Mode of action

Cetuximab is believed to operate by binding to the extracellular domain of the EGFR of all cells that express EGFR, preventing ligand binding and activation of the receptor. This blocks the downstream signaling of EGFR resulting in impaired cell growth and proliferation. Cetuximab has also been shown to mediate antibody-dependent cellular cytotoxicity (ADCC).

Clinical uses

Colorectal cancer

Cetuximab is used in metastatic colon cancer with irinotecan (Camptosar).[citation needed] Irinotecan blocks DNA topoisomerase I.

Head and neck cancer

Cetuximab was approved by the FDA in March 2006[2] for use in combination with radiation therapy for treating squamous cell carcinoma of the head and neck (SCCHN) or as a single agent in patients who have had prior platinum-based therapy.

Side effects

A possibly severe, debilitating, acne-like rash occurs in more than 30% of patients.

Several studies have reported that rash is less common with a similar monoclonal antibody, nimotuzumab[3].[4].

Development

The early development of cetuximab was by Esther Pirak, Esther Hurwitz, and Michael Sela, one of the developers of Copaxone, of the Weizmann Institute of Science, Rehovot, Israel. Commercial development was by ImClone Systems.

ImClone insider trading scandal

The initial failure of ImClone Systems to prepare an acceptable FDA filing led to the infamous Martha Stewart insider trading scandal when ImClone's CEO sold ImClone shares and this information was leaked to Stewart before the FDA announced its refusal to approve the drug for public use. Martha Stewart, Samuel D. Waksal (the founder and former CEO of ImClone), and their broker were indicted, and Stewart and Waksal were sentenced to prison. ImClone shares dropped sharply in the aftermath of the insider trading scandal.

A new clinical trial and FDA filing prepared by Imclone's partner Merck KGaA ("German Merck," not to be confused with the US company of similar name) resulted in an FDA approval of the drug in 2004 for use in the treatment of colon cancer.

KRAS Testing

The KRAS gene encodes a small G protein on the EGFR pathway. Cetuximab and other EGFR inhibitors only work on tumors that are not mutated.[5][6]

References

External links


 
 

 

Copyrights:

Drug Info. Gold Standard. Copyright © 2008 by Gold Standard. All rights reserved.  Read more
Wikipedia. This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Cetuximab" Read more