Active Ingredient: Capecitabine
Capecitabine is indicated for the treatment of:
For this indication, competent medicine agencies globally authorize below treatments:
Oral
2,500 mg per m² of body surface area (BSA)
1,250 mg per m² of body surface area (BSA) 2 time(s) per day every day for 14 day(s)
Given as monotherapy, the recommended starting dose for capecitabine in the adjuvant treatment of colon cancer, in the treatment of metastatic colorectal cancer or of locally advanced or metastatic breast cancer is 1250 mg/m² administered twice daily (morning and evening; equivalent to 2500 mg/m² total daily dose) for 14 days followed by a 7-day rest period. Adjuvant treatment in patients with stage III colon cancer is recommended for a total of 6 months.
Should be swallowed with water within 30 minutes after a meal.
Oral
1,250 - 2,000 mg per m² of body surface area (BSA)
From 625 To 1,000 mg per m² of body surface area (BSA) 2 time(s) per day every day for 14 day(s)
In combination treatment, the recommended starting dose of capecitabine should be reduced to 800-1000 mg/m² when administered twice daily for 14 days followed by a 7-day rest period, or to 625 mg/m² twice daily when administered continuously (see section 5.1). For combination with irinotecan, the recommended starting dose is 800 mg/m² when administered twice daily for 14 days followed by a 7-day rest period combined with irinotecan 200 mg/m² on day 1. The inclusion of bevacizumab in a combination regimen has no effect on the starting dose of capecitabine. Premedication to maintain adequate hydration and anti-emesis according to the cisplatin summary of product characteristics should be started prior to cisplatin administration for patients receiving the capecitabine plus cisplatin combination. Premedication with antiemetics according to the oxaliplatin summary of product characteristics is recommended for patients receiving the capecitabine plus oxaliplatin combination.
Adjuvant treatment in patients with stage III colon cancer is recommended for a duration of 6 months.
Should be swallowed with water within 30 minutes after a meal.
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