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Cetuximab

 
Drug Info: Cetuximab
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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
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Home > Library > Miscellaneous > Wikipedia
Cetuximab ?
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 intravenous

Cetuximab (IMC-C225—marketed under the name Erbitux) is a chimeric (mouse/human) monoclonal antibody, an epidermal growth factor receptor (EGFR) inhibitor, given by intravenous infusion for treatment of metastatic colorectal cancer and head and neck cancer.

Contents

Development

This agent is based on Dr. John Mendelsohn's 1980s hypothesis that monoclonal antibodies against EGFR could block receptor activation. Cetuximab was developed by Dr. Esther Pirak, Dr. Esther Hurwitz, and Prof. Michael Sela, one of the developers of Copaxone, of the Weizmann Institute of Science, Rehovot, Israel, as a chimeric human-mouse monoclonal antibody which was derived from the original anti-EGFR mouse monoclonal antibody 225 generated by Dr. Mendelsohn.

Distribution

Cetuximab is manufactured and distributed in North America by ImClone and Bristol-Myers Squibb, while in the rest of the world distribution is by Merck KGaA. Cetuximab costs approximately €4,300 for eight weeks of treatment per patient. It is given by intravenous therapy and costs up to $30,000 for eight weeks of treatment per patient.[1]

Indications

Cetuximab is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, KRAS wild-type metastatic colorectal cancer (mCRC), in combination with chemotherapy, and as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan. The positive opinion from the Committee for Medicinal Products for Human Use (CHMP) was received for mCRC 1st line use in May 2008.

Cetuximab (Erbitux) is indicated for the treatment of patients with squamous cell cancer of the head and neck in combination with platinum-based chemotherapy for the 1st line treatment of recurrent and/or metastatic disease and in combination with radiation therapy for locally advanced disease. The positive CHMP opinion for this indication was received in October 2008.

A diagnostic immunohistochemistry assay (EGFR pharmDx) can be used to detect EGFR expression in the tumor material. Approximately 75% of patients with metastatic colorectal cancer have an EGFR-expressing tumor and are therefore considered eligible for treatment with cetuximab (SPC).

Biomarkers

In mCRC, biomarkers, including KRAS, are indicative of response to cetuximab (Erbitux). 60% of patients express the KRAS wild-type tumor and data have shown that these patients are significantly more likely to benefit from treatment with cetuximab or a combination of cetuximab plus chemotherapy. Two recent studies demonstrated that patients with KRAS wild-type tumors demonstrated significantly increased response rates and disease free survival when treated with cetuximab and standard chemotherapy (OPUS AND CRYSTAL), compared to patients receiving chemotherapy alone.

There is increasing evidence to support the use of biomarkers in predicting tumor response to treatment, as this allows therapeutic approaches to be tailored or personalized to individual patients and results in improved outcomes and survival. While there remains some scientific controversy on this, assessment for EGFR expression is required for the use of cetuximab (Erbitux) in Colorectal Cancer, but not in Head & Neck Cancer.

Clinical uses

Colorectal cancer

Cetuximab is indicated for the treatment of patients with EGFR expressing, KRAS wild-type metastatic colorectal cancer in combination with chemotherapy or as a single agent in patients who have failed in oxaliplatin- or irinotecan- base therapy and who are intolerant to irinotecan. While there remains some scientific controversy on this, assessment for EGFR expression is required for use in colorectal cancer, but not in head & neck cancer. It is best to refer to updated Prescription Information.

Many clinical trials have been conducted to investigate the efficacy of cetuximab (Erbitux) in metastatic colorectal cancer (mCRC) and there is increasing evidence to support the use of biomarkers, such as KRAS, to predict tumor response to anti-EGFR therapies. Two large clinical trials of cetuximab, OPUS[2] and CRYSTAL,[3] have recently been published, and have provided further evidence that cetuximab significant improves response rates and disease free survival rates in mCRC patients with KRAS wild-type tumors.

Head and neck cancer

Cetuximab was approved by the FDA in March 2006[4] 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.

Two landmark studies have evaluated the benefits of cetuximab (Erbitux) in patients with SCCHN in both the locally advanced (Bonner trial) and the recurrent and/or metastatic (EXTREME trial) settings. The EXTREME trial is the first time in 30 years that a Phase III trial has demonstrated a survival benefit in 1st-line recurrent and/or metastatic disease. Erbitux was granted approval by the European Commission in November 2008 for the treatment of 1st-line recurrent and/or metastatic SCCHN based on the results of the EXTREME study.

Side effects

One of the side effects of Cetuximab therapy is the incidence of, possibly severe, acne-like rash. This rash rarely leads to dose reductions or termination of therapy. It is generally reversible after treatment is finished and may also be associated with a good response to therapy.

As well as severe infusion reactions including but not limited to: fevers, chills, rigors, urticaria, pruritis, rash, hypotension, N/V, HA, bronchospasm, dyspnea, wheezing, angioedema, dizziness, anaphylaxis, and cardiac arrest. Therefore, pretreatment with diphenhydramine 30-60 min. before administration is standard of care. Other common side effects include photosensitivity, hypomagnesaemia due to magnesium wasting, and less commonly pulmonary and cardiac toxicity. [5]

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.[6][7]

KRAS mutational analysis is commercially available from a number of laboratories.

In July 2009, the US Food and Drug Administration (FDA) updated the labels of two anti-EGFR monoclonal antibody drugs (panitumumab (Vectibix) and cetuximab (Erbitux)) indicated for treatment of metastatic colorectal cancer to include information about KRAS mutations.[8]

Studies have indicated that detection of KRAS gene mutations helps physicians identify patients that are unlikely to respond to treatment with targeted EGFR inhibitors, including cetuximab and panitumumab. Accordingly, genetic testing to confirm the absence of KRAS mutations (and so the presence of the KRAS wild-type gene), is now clinically routine before the start of treatment with EGFR inhibitors. mCRC patients with wild-type KRAS tumors have been shown to benefit from a response rate of over 60% and a decreased risk for progression of over 40% when treated with Erbitux as 1st-line therapy.[2] Recent data suggest that around 65% of mCRC patients have the KRAS wild-type gene.[3]

References

  1. ^ Schrag, D (July 2004). "The price tag on progress – chemotherapy for colorectal cancer". New England Journal of Medicine 351 (4): 317–319. doi:10.1056/NEJMp048143. PMID 15269308. http://content.nejm.org/cgi/content/extract/351/4/317. 
  2. ^ a b Bokemeyer C, Bondarenko I, Makhson A, Hartmann JT, Aparicio J, de Braud F, Donea S, Ludwig H, Schuch G, Stroh C, Loos AH, Zubel A, Koralewski P (February 2009). "Fluorouracil, leucovorin, and oxaliplatin with and without cetuximab in the first-line treatment of metastatic colorectal cancer". J. Clin. Oncol. 27 (5): 663–71. doi:10.1200/JCO.2008.20.8397. PMID 19114683. 
  3. ^ a b Van Cutsem E, Köhne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, D'Haens G, Pintér T, Lim R, Bodoky G, Roh JK, Folprecht G, Ruff P, Stroh C, Tejpar S, Schlichting M, Nippgen J, Rougier P (April 2009). "Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer". N. Engl. J. Med. 360 (14): 1408–17. doi:10.1056/NEJMoa0805019. PMID 19339720. 
  4. ^ Cetuximab Beneficial in Head and Neck Cancer - National Cancer Institute
  5. ^ 8. Micromedex Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically
  6. ^ http://www.asco.org/ASCO/Abstracts+%26+Virtual+Meeting/Abstracts?&vmview=abst_detail_view&confID=55&abstractID=34491
  7. ^ Cetuximab and chemotherapy as initial treatment for metastatic colorecal cancer, Eric Van Cutsem, et all, N Engl J Med 360:1408
  8. ^ OncoGenetics.Org (July 2009). "FDA updates Vectibix and Erbitux labels with KRAS testing info". OncoGenetics.Org. http://www.oncogenetics.org/web/fda-updates-vectibix-and-erbitux-labels-with-kras-testing-info. Retrieved 2009-07-20. 

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This entry is from Wikipedia, the leading user-contributed encyclopedia. It may not have been reviewed by professional editors (see full disclaimer)

 
 

 

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Drug Info. Gold Standard. Copyright © 2008 by Gold Standard. All rights reserved.  Read more
Wikipedia. This article is licensed under the Creative Commons Attribution/Share-Alike License. It uses material from the Wikipedia article "Cetuximab".  Read more