Capecitabine

Capecitabine is a nucleoside metabolic inhibitor indicated for: 

• adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. (
1.1) 


• perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. (
1.1) 


• treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. (
1.1) 




• treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline-or taxane-containing chemotherapy is not indicated. (
1.2) 


• treatment of patients with advanced or metastatic breast cancer in combination with docetaxel after disease progression on prior anthracycline-containing chemotherapy. (
1.2) 




• treatment of adults with unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer as a component of a combination chemotherapy regimen. (
1.3) 


• 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. (
1.3) 




• adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen. (
1.4)

• Single agent: 1,250 mg/m
²twice daily orally for the first 14 days of each 21-day cycle for a maximum of 8 cycles. (
2.1) In combination with Oxaliplatin-Containing Regimens: 1,000 mg/m
²orally twice daily for the first 14 days of each 21-day cycle for a maximum of 8 cycles in combination with oxaliplatin 130 mg/m
²administered intravenously on day 1 of each cycle. (
2.1)

• With Concomitant Radiation Therapy: 825 mg/m
²orally twice daily (
2.1)


• Without Radiation Therapy: 1,250 mg/m
²orally twice daily (
2.1)




• Single agent: 1,250 mg/m
²twice daily orally for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity. (
2.1)


• In Combination with Oxaliplatin: 1,000 mg/m
²orally twice daily for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity in combination with oxaliplatin 130 mg/m
²administered intravenously on day 1 of each cycle. (
2.1)




• Single agent: 1,000 mg/m
²or 1,250 mg/m
²twice daily orally for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity. (
2.2)


• In combination with docetaxel: 1,000 mg/m
²or 1,250 mg/m
²orally twice daily for the first 14 days of a 21-day cycle, until disease progression or unacceptable toxicity in combination with docetaxel at 75 mg/m
²administered intravenously on day 1 of each cycle (
2.2)




• 625 mg/m
²orally twice daily on days 1 to 21 of each 21-day cycle for a maximum of 8 cycles in combination with platinum-containing chemotherapy. (
2.3) OR


• 850 mg/m
²or 1,000 mg/m
²orally twice daily for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity in combination with oxaliplatin 130 mg/m
²administered intravenously on day 1 of each cycle. (
2.3)




• 1,000 mg/m
²orally twice daily for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity in combination with cisplatin and trastuzumab. (
2.3)




• 830 mg/m
²orally twice daily for the first 21 days of each 28-day cycle for maximum of 6 cycles in combination with gemcitabine 1,000 mg/m
²administered intravenously on days 1, 8, and 15 of each cycle. (
2.4)


Refer to Sections 2.5 and 2.6 for information related to dosage modifications for adverse reactions and renal impairment (
2.5and
2.6).

• 

Advise not to breastfeed. (
8.2) 


• 
Monitor patients with hepatic impairment more frequently for adverse reactions. (
8.7)