Severe skin reactions reported with oral chemotherapy Xeloda

Hoffmann-La Roche and Health Canada have announced the risk for severe skin reactions associated with capecitabine, an oral chemotherapy used to treat patients with advanced colorectal and breast cancers.

Rare cases of severe cutaneous reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), with some cases fatal, were reported for capecitabine (Xeloda) treatment, according to a press release.

If patients exhibit signs or symptoms of SJS or TEN, Xeloda treatment should be discontinued immediately, the release said.

Hoffmann-LaRoche announced it will work with Health Canada to implement appropriate changes to the product monograph for Xeloda.

Xeloda is approved in Canada as adjuvant treatment for patients with stage III colon cancer, first-line treatment for patients with metastatic colorectal cancer, and treating metastatic colon cancer, in combination with oxaliplatin, after irinotecan-containing combination therapy has failed, according to a press release. Xeloda also is approved for use in combination with docetaxel for patients with advanced or metastatic breast cancer after anthracycline-containing chemotherapy treatment has failed. It also is indicated for treating advanced or metastatic breast cancer after failure with a standard therapy that included a taxane.

The FDA in September authorized Teva Pharmaceuticals USA to market generic capecitabine in 150-mg and 500-mg pills to treat metastatic colorectal and breast cancers.