erbitux

Erbitux (cetuximab)

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Erbitux (cetuximab) is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in

the body.Erbitux is used to treat cancers of the colon and rectum. It is also

used to treat head and neck cancer.Erbitux is often used in combination with other cancer

medications.Erbitux may also be used for purposes not listed in this

medication guide.

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

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

Before receiving Erbitux, 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 Erbitux 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 Erbitux 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 Erbitux 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 this medicine and for at least 2 months after your treatment ends.

Erbitux can make you sunburn more easily.

You should not use Erbitux if you are allergic to cetuximab or to mouse protein.To make sure you can safely receive Erbitux, 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); oran electrolyte imbalance (such as low levels of potassium or magnesium in your

blood).FDA pregnancy category C. It is not known whether Erbitux will harm an unborn baby.

Tell your doctor if you are pregnant or plan to become pregnant while using this medication. 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 Erbitux 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. Whether you are a man or a woman, use effective birth control to prevent pregnancy while you

are receiving Erbitux, and for at least 6 months after your treatment ends.

Erbitux (cetuximab) is a recombinant, human/mouse chimeric monoclonal antibody that binds specifically to the extracellular domain of the

humanepidermal growth factor receptor (EGFR). Cetuximab is composed of the Fv regions of a murine anti-EGFR antibody with human IgG1 heavy and

kappa light chain constant regions and has an approximate molecular weight of 152 kDa. Cetuximab is produced in mammalian (murine myeloma) cell

culture.Erbitux is a sterile, clear, colorless liquid of pH 7.0 to 7.4, which may contain a

small amount of easily visible, white, amorphous cetuximab particulates. Erbitux is supplied at a concentration of 2 mg/mL in either 100 mg (50 mL) or 200 mg (100 mL), single-use vials. Cetuximab is formulated in a solution with no preservatives, which contains 8.48 mg/mL sodium chloride, 1.88 mg/mL

sodium phosphate dibasic heptahydrate, 0.41 mg/mL sodium phosphate monobasic monohydrate, and Water for Injection, USP.

What are the possible side effects of cetuximab (Erbitux)?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.

ASCO 2014: Chemo with either Avastin or Erbitux are equally effective against colorectal cancer

Results from a large-scale study found that four commonly-prescribed drug regimens are equally effective for most types of colorectal cancer. The findings were presented during the plenary session at the American Society of Clinical

Oncology's annual meeting.

A new study presented at ASCO's annual meeting found that chemotherapy plus either Avastin or Erbitux are equally effective against most kinds of colorectal

cancer.

The researchers reported that, for metastatic colorectal cancerpatients who do not have a KRAS 12/13 gene mutation, nearly identical results were seen from

taking chemotherapy with either bevacizumab (trade name Avastin) or cetuximab (trade name Erbitux).

According to Marwan Fakih, M.D., director of City of Hope's gastrointestinal medical oncology program, these results mean that patients and their doctors can choose a regimen based on other factors — such as side effects

— without having to worry about a reduction in effectiveness.

"For now, this report's message is simple: no change in standard practice in the United States," said Fakih, who is not involved in this study.

For this federally funded phase III clinical trial, more than 1,100 metastatic colorectal cancer patients are randomized to receive one targeted therapy (bevacizumab or cetuximab) and one chemotherapy combination

(FOLFIRI orFOLFOX). The researchers hypothesized that bevacizumab and cetuximab may have varied in efficacy due to their different mechanisms of action. Bevacizumab prevents tumor growth and spreads by blocking the

formation of new blood vessels while cetuximab works by inhibiting a growth factor that is used for cancer cells' uncontrolled division.

After patient follow-ups and data evaluation, the researchers found that there were no significant differences between the bevacizumab+chemotherapy and cetuximab+chemotherapy groups in either overall survival (29 months versus 29.9 months, respectively) or progression-free survival (10.8 versus 10.4 months, respectively.)The FOLFOX/FOLFIRI comparison was excluded in this analysis, since most patients in this trial were given the

former combination.The team also reported that all groups had similar quality of life but noted that drugs had different side effects.

Bevacizumab's side effects include high blood pressure, diarrhea and mouth sores while cetuximab's include itching, acne-like skin rash and low blood electrolyte levels. Likewise, FOLFIRI can cause hair loss and diarrhea

while FOLFOX can cause nerve damage.Thus, patients and their doctors can choose a treatment program based on their quality-of-life concerns.

Although this trial's findings do not change current clinical practice, Fakih said that future analyses of this and other phase III trials can yield more definitive results, such as biologic or genomic markers that favor one

regimen over another.For the time being, patients with colorectal cancers are encouraged to discuss it with their doctors and ask

about their treatment options to find an effective regimen that they are comfortable with.**

This monoclonal antibody attacks the same molecular target as ImClone Systems’ Erbitux, but it is based on a new technology used to create “fully human” antibody

drugs. The hope is that fully human antibodies will cause fewer allergic reactions than part-mouse antibodies, such as Erbitux. In clinical trials, Erbitux caused severe allergic

reactions in approximately 3% of patients. In November, the Thousand Oaks, Calif.-company chalked up a big win when a final-stage test of 463 advanced colon cancer

patients found that the drug slashed the rate of cancer progression by 46%. On March 30, Amgen said it had finished submitting an application for approval to the FDA.

This colon cancer drug is somewhat similar to Genentech’s blood vessel blocker Avastin, but in pill form. Like Avastin, it aims to

shut down the tumor’s blood supply by blocking the three receptors for vascular endothelial growth factor, or VEGF, which tumors use to attract blood vessels. (Avastin blocks VEGF itself.) In early trials, the PTK-787 compound shrunk tumors in 15 of 28

colon cancer patients when combined with chemotherapy. A first look at final-stage trials failed to show a benefit, meaning the drug will not go before the U.S. Food and Drug Administration

until 2006 at the earliest. Though those results were discouraging, the trials could still show a benefit.

References:

http://breakthroughs.cityofhope.org/asco-2014-colorectal-cancer-erbitux-avastin