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Association of Capecitabine with Stevens-Johnson syndrome and toxic epidermal necrolysis


The health care professionals have been informed of the risk of severe cutaneous reactions associated with the use of Capecitabine ( Xeloda ).

Xeloda is authorized for the following indications:

a) Colorectal cancer: Adjuvant treatment of patients with stage III ( Dukes’ stage C ) colon cancer; first-line treatment of patients with metastatic colorectal cancer; treatment of metastatic colorectal cancer, in combination with Oxaliplatin, following failure of Irinotecan-containing combination chemotherapy.

b) Breast cancer: Treatment of patients with advanced or metastatic breast cancer, in combination with Docetaxel, after failure of prior anthracycline containing chemotherapy; treatment of advanced or metastatic breast cancer after failure of standard therapy including a taxane, unless therapy with a taxane is clinically contraindicated.

Very rare cases of severe cutaneous reactions such as Stevens-Johnson syndrome ( SJS ) and toxic epidermal necrolysis ( TEN ), in some cases with fatal outcome, have been reported during treatment with Capecitabine.

Capecitabine should be immediately discontinued if signs and symptoms of SJS or TEN are present. ( Xagena )

Source: Health Canada, 2013

XagenaMedicine_2013



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