Capecitabine

1). 1). 1). 1) for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.

Caution:

ACH-CAPECITABINE (capecitabine) is a potent drug and should be prescribed only by physicians experienced with cancer chemotherapeutic drugs.

ACH-CAPECITABINE (capecitabine) is indicated for:

Colorectal Cancer Monotherapy • ACH-CAPECITABINE (capecitabine) is indicated for the adjuvant treatment of patients with stage III (Dukes’ stage C) colon cancer. • ACH-CAPECITABINE is also indicated for the first-line treatment of patients with metastatic colorectal cancer.

Combination Therapy ACH-CAPECITABINE in combination with oxaliplatin is indicated for the treatment of metastatic colorectal cancer following failure of irinotecan-containing combination chemotherapy. In second-line metastatic disease, subgroup analyses for PFS and OS for age suggest that ACH- CAPECITABINE in combination with oxaliplatin may be less effective in patients over the age of 65.

1). 1). 1). 1) for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. - as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.

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1 INDICATIONS AND USAGE Capecitabine tablet is a nucleoside metabolic inhibitor indicated for: Colorectal Cancer • adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen.

1 ) • perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. 1 ) • treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen.

1 ) Breast Cancer • treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline-or taxane-containing chemotherapy is not indicated. 2 ) • treatment of patients with advanced or metastatic breast cancer in combination with docetaxel after disease progression on prior anthracycline-containing chemotherapy.

2 ) Gastric, Esophageal, or Gastroesophageal Junction Cancer • treatment of adults with unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer as a component of a combination chemotherapy regimen. 3 ) • treatment of adults with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease as a component of a combination regimen.