Erbitux

Erbitux

cetuximab

Manufacturer:

Merck

Distributor:

Zuellig
Concise Prescribing Info
Contents
Cetuximab
Indications/Uses
Treatment of patients w/ epidermal growth factor receptor (EGRF)-expressing, RAS wild-type metastatic colorectal cancer: In combination w/ irinotecan-based chemotherapy or continuous infusional 5-fluorouracil/folinic acid plus oxaliplatin & as a single agent in patients who have failed oxaliplatin- & irinotecan-based therapy & who are intolerant to irinotecan. Treatment of patients w/ squamous cell cancer of the head & neck (SCCHN): In combination w/ radiotherapy for locally advanced disease, in combination w/ platinum-based chemotherapy for recurrent &/or metastatic disease & as a single agent for patients who have failed chemotherapy for recurrent &/or metastatic disease.
Dosage/Direction for Use
Administered once a wk. Initially 400 mg/m2 for 120 min. Subsequent wkly doses: 250 mg/m2 for 60 min. Max infusion rate: 10 mg/min. Premed prior to infusion: antihistamine & a corticosteroid at least 1 hr prior to administration of cetuximab.
Contraindications
Hypersensitivity. Combination w/ oxaliplatin-containing chemotherapy for patients w/ mutant RAS metastatic colorectal cancer (mcRC) or for whom RAS mCRC status is unknown. Pregnancy & lactation.
Special Precautions
Severe infusion-related including anaphylactic reactions. Discontinue treatment if interstitial lung disease & ulcerative keratitis is diagnosed; severe skin reactions occur. Electrolyte disturbances. Increased risk for severe neutropenia. Increased frequency of severe & sometimes fatal CV events & treatment emergent deaths. History of keratitis, ulcerative keratitis or severe dry eye. Should not be used in the treatment of colorectal cancer patients whose tumor have RAS mutations or for whom RAS tumor status is unknown. May impair ability to drive or operate machinery. Childn.
Adverse Reactions
Skin reactions; hypomagnesemia; mild or moderate infusion-related reactions, mucositis which may lead to epistaxis; increase in liver enzyme levels. Headache; conjunctivitis; diarrhea, nausea, vomiting; dehydration in particular secondary to diarrhea or mucositis; hypocalcemia; anorexia which may lead to wt decrease; severe infusion-related reactions in some cases w/ fatal outcome; fatigue.
Drug Interactions
Increased frequency of severe leukopenia or severe neutropenia w/ platinum-based chemotherapy. Increased frequency of cardiac ischemia including MI & CHF, & hand-foot syndrome (palmar-plantar erythrodysesthesia) w/ fluoropyrimidines. Increased frequency of severe diarrhea w/ capecitabine & oxaliplatin (Xelox).
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01FE01 - cetuximab ; Belongs to the class of EGFR (Epidermal Growth Factor Receptor) inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Erbitux inj 5 mg/mL
Packing/Price
(vial) 20 mL x 1's
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