Deepika vegiraju at 13:34, 15 June 2022

2022-06-15T13:34:03Z

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== '''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.

[[File:Cetuximab.png|thumb|Cetuximab]]

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== '''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 based chemotherapy|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?''' ==

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* 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?''' ==

* {{overdose}}

== '''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 Systems, LLC. d.b.a. Eli Lilly and Company|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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Cetuximab - Revision history

Deepika vegiraju at 13:34, 15 June 2022