Cetuximab

What is Cetuximab?

• Cetuximab (Erbitux) is an epidermal growth factor receptor (EGFR) antagonist used to treat certain types of head and neck cancer, and a certain type of colorectal cancer that has spread to other parts of the body.

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Cetuximab

What are the uses of this medicine?

Cetuximab (Erbitux) is approved to be used alone or with other drugs to treat:

Colorectal cancer that has metastasized (spread to other parts of the body). It is used:

• In patients whose cancer has the EGFR protein and the wild-type KRAS gene.
• With FOLFIRI combination chemotherapy as the first treatment.
• With irinotecan hydrochloride in patients whose cancer was treated with chemotherapy that included irinotecan hydrochloride but it did not work or is no longer working.
• Alone in patients whose cancer did not respond to oxaliplatin and irinotecan hydrochloride or who cannot be treated with irinotecan hydrochloride.
• In adults whose cancer has a certain mutation in the BRAF gene. It is given with [[encorafenib\\.

Squamous cell carcinoma of the head and neck. It is used:

• With radiation therapy in patients with locally or regionally advanced cancer.
• With platinum chemotherapy and fluorouracil in patients with locally or regionally recurrent cancer or metastatic cancer.
• Alone in patients with recurrent or metastatic cancer that got worse after platinum chemotherapy.

Limitations of use:

• Erbitux is not indicated for treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown.

How does this medicine work?

• Cetuximab (se tux’ i mab) is a chimeric mouse-human monoclonal IgG1 kappa antibody to the human epidermal growth factor (EGF) receptor which is present on many normal cell types and is overexpressed in several forms of cancer.
• Cetuximab has been shown to prolong survival in patients with EGF receptor expressing and wild type KRAS expressing colorectal cancer.
• Cetuximab has also been shown to be effective in patients with squamous cell carcinoma of the head and neck.

Who Should Not Use this medicine ?

Limitations of use:

• Erbitux is not indicated for treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Erbitux.

Is this medicine FDA approved?

• Cetuximab was approved for use the United States in 2004 and current indications include metastatic colorectal and head and neck cancer usually in combination with other antineoplastic agents or radiation therapy.

How should this medicine be used?

Select patients with metastatic colorectal cancer (CRC) for treatment with Erbitux based on the presence of:

• Ras wild-type, EGFR-expressing CRC or
• BRAF V600E mutation-positive metastatic CRC

• Premedicate with an H1 receptor antagonist.

Recommended dosage: In Combination With Radiation Therapy:

• Initial dose: 400 mg/m2 administered as a 120-minute intravenous infusion one week prior to initiating a course of radiation therapy.
• Subsequent doses: 250 mg/m2 administered as a 60-minute infusion every week for the duration of radiation therapy (6–7 weeks).
• Complete Erbitux administration 1 hour prior to radiation therapy.

As Single-Agent or in Combination With Chemotherapy:

• Weekly: Administer initial dose of 400 mg/m2 as a 120-minute intravenous infusion, and subsequent doses of 250 mg/m2 infused over 60 minutes once weekly.
• Biweekly: Administer 500 mg/m2 as a 120-minute intravenous infusion every two weeks.
• Complete Erbitux administration 1 hour prior to chemotherapy.
• Continue treatment until disease progression or unacceptable toxicity.

Administration:

• Do not administer Erbitux as an intravenous push or bolus.
• Administer via infusion pump or syringe pump.
• Do not exceed an infusion rate of 10 mg/min.
• Administer through a low protein binding 0.22-micrometer in-line filter.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 100 mg/50 mL (2 mg/mL) or 200 mg/100 mL (2 mg/mL) in a single-dose vial.

This medicine is available in fallowing brand namesː

• Erbitux

What side effects can this medication cause?

The most common side effects of this medicine include: When Erbitux is used as a single-agent or in combination with radiotherapy or chemotherapy (FOLFIRI, Irinotecan and 5-Fluorouracil/Platinum):

• cutaneous adverse reactions (including rash, pruritus, and nail changes)
• headache
• diarrhea
• infection

When Erbitux is used in combination with encorafenib:

• fatigue
• nausea
• diarrhea
• dermatitis acneiform
• abdominal pain
• decreased appetite
• arthralgia
• rash

What special precautions should I follow?

• Erbitux can cause serious and fatal infusion reactions. Monitor patients following infusion. Immediately stop and permanently discontinue Erbitux for serious infusion reactions.
• Erbitux can cause cardiopulmonary arrest. Monitor serum electrolytes during and after Erbitux.
• Erbitux can cause interstitial lung disease (ILD). Interrupt or permanently discontinue for acute onset or worsening of pulmonary symptoms.
• Erbitux can cause dermatologic toxicities, including acneiform rash, skin drying and fissuring, paronychial inflammation, infectious sequelae. Monitor for dermatologic toxicities or infectious sequelae. Limit sun exposure.
• Erbitux can cause hypomagnesemia. Monitor during treatment and for at least 8 weeks following the completion. Replete electrolytes as necessary.
• Increased tumor progression, increased mortality, or lack of benefit observed in patients with Ras-mutant mCRC.
• Erbitux Can cause fetal harm. Advise females of potential risk to the fetus and to use effective contraception.
• Cetuximab has been linked to mild and transient serum enzyme elevations during therapy, but has not been implicated in cases of clinically apparent acute liver injury.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on findings from animal studies and its mechanism of action , Erbitux can cause fetal harm when administered to a pregnant woman.
• There are no available data for Erbitux exposure in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of Erbitux in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredients include:

• cetuximab

Inactive ingredients include:

• SODIUM CHLORIDE
• SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
• SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
• SODIUM HYDROXIDE
• HYDROCHLORIC ACID
• WATER

Who manufactures and distributes this medicine?

• Erbitux® is a registered trademark of ImClone LLC a wholly-owned subsidiary of Eli Lilly and Company.
• Manufactured by ImClone LLC a wholly-owned subsidiary of Eli Lilly and Company, Branchburg, NJ

What should I know about storage and disposal of this medication?

• Store vials under refrigeration at 2° C to 8° C (36° F to 46° F).
• Do not freeze or shake.
• Increased particulate formation may occur at temperatures at or below 0° C (32° F).
• Discard any remaining solution in the infusion container after 8 hours at controlled room temperature or after 12 hours at 2° C to 8° C.
• Discard any unused portion of the vial.

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• Dailymed label info on Cetuximab
• FDA Cetuximab

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