Description
Description
Active ingredient: Capecitabine
Each 1 coated tablet contains 500 mg capecitabine.
Xeloda is the brand innovator for Capecitabine – FDA approved.
Indications:
XELODA (capecitabine) 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.
- perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy.
- treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen.
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.
- treatment of patients with advanced or metastatic breast cancer in combination with docetaxel after disease progression on prior anthracycline-containing chemotherapy.
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.
- 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.
Pancreatic Cancer
- adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen.
Dosage and route of administration
Recommended Dosage for Colorectal Cancer
Adjuvant Treatment of Colon Cancer
Single Agent
The recommended dosage of XELODA is 1,250 mg/m2 orally twice daily for the first 14 days of each 21-day cycle for a maximum of 8 cycles. In Combination with Oxaliplatin-Containing Regimens The recommended dosage of XELODA is 1,000 mg/m2 orally twice daily for the first 14 days of each 21-day cycle for a maximum of 8 cycles in combination with oxaliplatin 130 mg/m2 administered intravenously on day 1 of each cycle. Refer to the oxaliplatin prescribing information for additional dosing information as appropriate.
Perioperative Treatment of Rectal Cancer
The recommended dosage of capecitabine is 825 mg/m2 orally twice daily when administered with concomitant radiation therapy and 1,250 mg/m2 orally twice daily when administered without radiation therapy as part of a peri-operative combination regimen.
Unresectable or Metastatic Colorectal Cancer
Single Agent The recommended dosage of XELODA is 1,250 mg/m2 orally twice daily for the first 14 days of a 21-day cycle until disease progression or unacceptable toxicity.
In Combination with Oxaliplatin
The recommended dosage of XELODA is 1,000 mg/m2 orally twice daily for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity in combination with oxaliplatin 130 mg/m2 administered intravenously on day 1 of each cycle. Refer to the Prescribing Information for oxaliplatin for additional dosing information as appropriate.
Recommended Dosage for Breast Cancer
Advanced or Metastatic Breast Cancer
Single Agent
The recommended dosage of XELODA is 1,000 mg/m2 or 1,250 mg/m2 orally twice daily for the first 14 days of a 21-day cycle until disease progression or unacceptable toxicity. Individualize the dose and dosing schedule of XELODA based on patient risk factors and adverse reactions.
In Combination with Docetaxel
The recommended dosage of XELODA is 1,000 mg/m2 or 1,250 mg/m2 orally twice daily for the first 14 days of a 21-day cycle until disease progression or unacceptable toxicity in combination with docetaxel 75 mg/m2 administered intravenously on day 1 of each cycle. Refer to the Prescribing Information for docetaxel for additional dosing information as appropriate.
Recommended Dosage for Gastric, Esophageal, or Gastroesophageal Junction Cancer
The recommended dosage of XELODA for unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer is:
- 625 mg/m2 orally twice daily on days 1 to 21 of each 21-day cycle for a maximum of 8 cycles in combination with platinum-containing chemotherapy.
OR
- 850 mg/m2 or 1,000 mg/m2 orally twice daily for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity in combination with oxaliplatin 130 mg/m2 administered intravenously on day 1 of each cycle. Individualize the dose and dosing schedule of XELODA based on patient risk factors and adverse reactions.
The recommended dosage of XELODA for HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma is 1,000 mg/m2 orally twice daily for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity in combination with cisplatin and trastuzumab.
Refer to the Prescribing Information for agents used in combination for additional dosing information as appropriate.
Recommended Dosage for Pancreatic Cancer
The recommended dosage of XELODA is 830 mg/m2 orally twice daily for the first 21 days of each 28-day cycle until disease progression, unacceptable toxicity, or for a maximum 6 cycles in combination with gemcitabine 1,000 mg/m2 administered intravenously on days 1, 8, and 15 of each cycle.
Refer to Prescribing Information for gemcitabine for additional dosing information as appropriate.
Dosage Modifications for Adverse Reactions
Monitor patients for adverse reactions and modify dosages of XELODA as described in Table 1. Do not replace missed doses of XELODA; instead resume XELODA with the next planned dosage.
When XELODA is administered with docetaxel, withhold XELODA and docetaxel until the requirements for resuming both XELODA and docetaxel are met.
Refer to the Prescribing Information for docetaxel for additional dosing information as appropriate.
Hyperbilirubinemia
Patients with Grade 3-4 hyperbilirubinemia may resume treatment once the event is Grade 2 or less (less than three times the upper limit of normal), using the percent of current dose as shown in column 3 of Table 1 [
Dosage Modification for Renal Impairment
Reduce the dose of XELODA by 25% for patients with creatinine clearance (CLcr) of 30 to 50 mL/min as determined by Cockcroft-Gault equation. A dosage has not been established in patients with severe renal impairment (CLcr <30 mL/min)
Method of administration
Swallow XELODA tablets whole with water within 30 minutes after a meal. Do not chew, cut, or crush XELODA tablets [see Warnings and Precautions.
Take XELODA at the same time each day approximately 12 hours apart.
Do not take an additional dose after vomiting and continue with the next scheduled dose.
Do not take a missed dose and continue with the next scheduled dose.
XELODA is a hazardous drug. Follow applicable special handling and disposal procedures.
