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西妥昔单抗注射剂说明书（英文）.pdf

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HIGHLIGHTS OF PRESCRIBING INFORMATION • Retrospective subset analyses of metastatic or advanced colorectal
These highlights do not include all the information needed to use cancer trials have not shown a treatment benefit for Erbitux in patients
ERBITUX safely and effectively. See full prescribing information for whose tumors had KRAS mutations in codon 12 or 13. Use of Erbitux
ERBITUX. is not recommended for the treatment of colorectal cancer with these
® mutations. (, , )
ERBITUX (cetuximab)
------------------------DOSAGE AND ADMINISTRATION----------------------
injection, for intravenous infusion
Initial . Approval: 2004 • Premedicate with an H1 antagonist. ()
2
• Administer 400 mg/m initial dose as a 120-minute intravenous
WARNING: SERIOUS INFUSION REACTIONS and 2
infusion followed by 250 mg/m weekly infused over 60 minutes. (,
CARDIOPULMONARY ARREST
)
See full prescribing information for complete boxed warning.
• Initiate Erbitux one week prior to initiation of radiation therapy.

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