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L. Hudson Lori
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Brand Name:Xeloda Trade Name:capecitabine
FDA Approved For:XELODA is indicated for the treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated, e.g., patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents. Resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse within 6 months of completing treatment with an anthracycline-containing adjuvant regimen. This indication is based on demonstration of a response rate. No results are available from controlled trials that demonstrate a clinical benefit resulting from treatment, such as improvement in diseaserelated symptoms, disease progression, or survival. Pediatric Use:The safety and effectiveness of XELODA in persons <18 years of age have not been established.
Carcinogen:Long-term studies in animals to evaluate the carcinogenic potential of capecitabine have not been conducted. Mutagen:Capecitabine was not mutagenic in vitro to bacteria (Ames test) or mammalian cells (Chinese hamster V79/HPRT gene mutation assay). Capecitabine was clastogenic in vitro to human peripheral blood lymphocytes but not clastogenic in vivo to mouse bone marrow (micronucleus test). Fluorouracil causes mutations in bacteria and yeast. Fluorouracil also causes chromosomal abnormalities in the mouse micronucleus test in vivo.
Manufacturer and/or Distributor:Roche   

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EditText of this page (last edited August 23, 2008)

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