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Xeloda Prescribing Information
Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking XELODA concomitantly with oral vitamin K antagonists, such as warfarin
[see , ]
.Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking XELODA concomitantly with vitamin K antagonists, such as warfarin.
Clinically significant increases in PT and INR have been reported in patients who were on stable doses of oral vitamin K antagonists at the time XELODA was introduced. These events occurred within several days and up to several months after initiating XELODA and, in a few cases, within 1 month after stopping XELODA. These events occurred in patients with and without liver metastases.
Monitor INR more frequently and adjust the dose of the vitamin K antagonist as appropriate
[see Drug Interactions (7.1)].
CYP2C9 Substrates
XELODA increased exposure of CYP2C9 substrates
[see Clinical Pharmacology (12.3)]
, which may increase the risk of adverse reactions related to these substrates. Closely monitor for adverse reactions of CYP2C9 substrates where minimal concentration changes may lead to serious adverse reactions when used concomitantly with XELODA (e.g., anticoagulants, antidiabetic drugs).Vitamin K Antagonists
XELODA increases exposure of vitamin K antagonist
[see Clinical Pharmacology (12.3)],
which m
ay alter coagulation parameters and/or bleeding and could result in death[see Warning and Precautions (5.1)]
. These events may occur within days of treatment initiation and up to 1 month after discontinuation of XELODA.Monitor INR more frequently and refer to the prescribing information of oral vitamin K antagonist for dosage adjustment, as appropriate, when XELODA is used concomitantly with vitamin K antagonist.
Phenytoin
XELODA may increases exposure of phenytoin, which may increase the risk of adverse reactions related to phenytoin. Closely monitor phenytoin levels and refer to the prescribing information of phenytoin for dosage adjustment, as appropriate, when XELODA is used concomitantly with phenytoin.
Clinically significant increases in prothrombin time (PT) and international normalized ratio (INR) have been reported in patients who were on stable doses of a vitamin K antagonist at the time XELODA was introduced. These events occurred within several days and up to several months after initiating XELODA and, in a few cases, within 1 month after stopping XELODA. These events occurred in patients with and without liver metastases.
Monitor INR more frequently and adjust the dose of the vitamin K antagonist as appropriate
[see ]
.CYP2C9 Substrates
XELODA increased exposure of CYP2C9 substrates
[see Clinical Pharmacology (12.3)]
, which may increase the risk of adverse reactions related to these substrates. Closely monitor for adverse reactions of CYP2C9 substrates where minimal concentration changes may lead to serious adverse reactions when used concomitantly with XELODA (e.g., anticoagulants, antidiabetic drugs).Vitamin K Antagonists
XELODA increases exposure of vitamin K antagonist
[see Clinical Pharmacology (12.3)],
which m
ay alter coagulation parameters and/or bleeding and could result in death[see Warning and Precautions (5.1)]
. These events may occur within days of treatment initiation and up to 1 month after discontinuation of XELODA.Monitor INR more frequently and refer to the prescribing information of oral vitamin K antagonist for dosage adjustment, as appropriate, when XELODA is used concomitantly with vitamin K antagonist.
Phenytoin
XELODA may increases exposure of phenytoin, which may increase the risk of adverse reactions related to phenytoin. Closely monitor phenytoin levels and refer to the prescribing information of phenytoin for dosage adjustment, as appropriate, when XELODA is used concomitantly with phenytoin.
WARNING: INCREASED RISK OF BLEEDING WITH CONCOMITANT USE OF VITAMIN K ANTAGONISTS Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking XELODA concomitantly with oral vitamin K antagonists, such as warfarin [see Warnings and Precautions (5.1), Drug Interactions (7.2)] .Clinically significant increases in prothrombin time (PT) and international normalized ratio (INR) have been reported in patients who were on stable doses of a vitamin K antagonist at the time XELODA was introduced. These events occurred within several days and up to several months after initiating XELODA and, in a few cases, within 1 month after stopping XELODA. These events occurred in patients with and without liver metastases. Monitor INR more frequently and adjust the dose of the vitamin K antagonist as appropriate [see Drug Interactions (7.2)] .WARNING: INCREASED RISK OF BLEEDING WITH CONCOMITANT USE OF VITAMIN K ANTAGONISTS See full prescribing information for complete boxed warning . Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking XELODA concomitantly with oral vitamin K antagonists. Monitor international normalized ratio (INR) more frequently and adjust the dose of the vitamin K antagonist as appropriate. | (12/2022) |
Indications and Usage, Colorectal Cancer (XELODA is indicated for the:
| (12/2022) |
Indications and Usage, Breast Cancer (XELODA is indicated for the:
| (12/2022) |
Indications and Usage, Gastric, Esophageal, or Gastroesophageal Junction Cancer (XELODA is indicated for the:
| (12/2022) |
Indications and Usage, Pancreatic Cancer (XELODA is indicated for the adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen. | (12/2022) |
Dosage and Administration (Adjuvant Treatment of Colon Cancer Single Agent The recommended dosage of XELODA is 1,250 mg/m2orally 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/m2orally twice daily for the first 14 days of each 21-day cycle for a maximum of 8 cycles in combination with oxaliplatin 130 mg/m2administered 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/m2orally twice daily when administered with concomitant radiation therapy and 1,250 mg/m2orally 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/m2orally 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/m2orally twice daily for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity in combination with oxaliplatin 130 mg/m2administered intravenously on day 1 of each cycle. Refer to the Prescribing Information for oxaliplatin for additional dosing information as appropriate. Round the recommended dosage for patients to the nearest 150 mg dose to provide whole XELODA tablets. Swallow XELODA tablets whole with water within 30 minutes after a meal. Do not chew, cut, or crush XELODA tablets [see Warnings and Precautions (5.12)]. 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.1 | (12/2022) |
Contraindications (XELODA is contraindicated in patients with history of severe hypersensitivity reaction to fluorouracil or capecitabine [see Adverse Reactions (6.1)] .History of severe hypersensitivity reactions to fluorouracil or capecitabine | (12/2022) |
Warnings and Precautions (Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking XELODA concomitantly with vitamin K antagonists, such as warfarin. Clinically significant increases in PT and INR have been reported in patients who were on stable doses of oral vitamin K antagonists at the time XELODA was introduced. These events occurred within several days and up to several months after initiating XELODA and, in a few cases, within 1 month after stopping XELODA. These events occurred in patients with and without liver metastases. Monitor INR more frequently and adjust the dose of the vitamin K antagonist as appropriate [see Drug Interactions (7.1)]. In instances of exposure to crushed XELODA tablets, the following adverse reactions have been reported: eye irritation and swelling, skin rash, diarrhea, paresthesia, headache, gastric irritation, vomiting and nausea. Advise patients not to cut or crush tablets. If XELODA tablets must be cut or crushed, this should be done by a professional trained in safe handling of cytotoxic drugs using appropriate equipment and safety procedures [see Dosage and Administration (2.7)]. The safety and effectiveness have not been established for the administration of crushed XELODA tablets. | (12/2022) |
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. ()
1.1 Colorectal CancerXELODA is indicated for the:- 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.
- perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. ()
1.1 Colorectal CancerXELODA is indicated for the:- 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.
- treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. ()
1.1 Colorectal CancerXELODA is indicated for the:- 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. ()
1.2 Breast CancerXELODA is indicated for the:- 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.
- treatment of patients with advanced or metastatic breast cancer in combination with docetaxel after disease progression on prior anthracycline-containing chemotherapy. ()
1.2 Breast CancerXELODA is indicated for the:- 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. ()
1.3 Gastric, Esophageal, or Gastroesophageal Junction CancerXELODA is indicated for the:- 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.
- 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 Gastric, Esophageal, or Gastroesophageal Junction CancerXELODA is indicated for the:- 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. ()
1.4 Pancreatic CancerXELODA is indicated for the adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen.
Adjuvant Treatment of Colon Cancer
- Single agent: 1,250 mg/m2 twice daily orally for the first 14 days of each 21-day cycle for a maximum of 8 cycles. () In combination with Oxaliplatin-Containing Regimens: 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. (
2.1 Recommended Dosage for Colorectal CancerAdjuvant Treatment of Colon CancerSingle AgentThe recommended dosage of XELODA is 1,250 mg/m2orally twice daily for the first 14 days of each 21-day cycle for a maximum of 8 cycles.In Combination with Oxaliplatin-Containing RegimensThe recommended dosage of XELODA is 1,000 mg/m2orally twice daily for the first 14 days of each 21-day cycle for a maximum of 8 cycles in combination with oxaliplatin 130 mg/m2administered intravenously on day 1 of each cycle.Refer to the oxaliplatin prescribing information for additional dosing information as appropriate.Perioperative Treatment of Rectal CancerThe recommended dosage of capecitabine is 825 mg/m2orally twice daily when administered with concomitant radiation therapy and 1,250 mg/m2orally twice daily when administered without radiation therapy as part of a peri-operative combination regimen.Unresectable or Metastatic Colorectal CancerSingle AgentThe recommended dosage of XELODA is 1,250 mg/m2orally twice daily for the first 14 days of a 21-day cycle until disease progression or unacceptable toxicity.In Combination with OxaliplatinThe recommended dosage of XELODA is 1,000 mg/m2orally twice daily for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity in combination with oxaliplatin 130 mg/m2administered intravenously on day 1 of each cycle.Refer to the Prescribing Information for oxaliplatin for additional dosing information as appropriate.)2.1 Recommended Dosage for Colorectal CancerAdjuvant Treatment of Colon CancerSingle AgentThe recommended dosage of XELODA is 1,250 mg/m2orally twice daily for the first 14 days of each 21-day cycle for a maximum of 8 cycles.In Combination with Oxaliplatin-Containing RegimensThe recommended dosage of XELODA is 1,000 mg/m2orally twice daily for the first 14 days of each 21-day cycle for a maximum of 8 cycles in combination with oxaliplatin 130 mg/m2administered intravenously on day 1 of each cycle.Refer to the oxaliplatin prescribing information for additional dosing information as appropriate.Perioperative Treatment of Rectal CancerThe recommended dosage of capecitabine is 825 mg/m2orally twice daily when administered with concomitant radiation therapy and 1,250 mg/m2orally twice daily when administered without radiation therapy as part of a peri-operative combination regimen.Unresectable or Metastatic Colorectal CancerSingle AgentThe recommended dosage of XELODA is 1,250 mg/m2orally twice daily for the first 14 days of a 21-day cycle until disease progression or unacceptable toxicity.In Combination with OxaliplatinThe recommended dosage of XELODA is 1,000 mg/m2orally twice daily for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity in combination with oxaliplatin 130 mg/m2administered intravenously on day 1 of each cycle.Refer to the Prescribing Information for oxaliplatin for additional dosing information as appropriate.
Perioperative Treatment of Rectal Cancer
- With Concomitant Radiation Therapy: 825 mg/m2 orally twice daily ()
2.1 Recommended Dosage for Colorectal CancerAdjuvant Treatment of Colon CancerSingle AgentThe recommended dosage of XELODA is 1,250 mg/m2orally twice daily for the first 14 days of each 21-day cycle for a maximum of 8 cycles.In Combination with Oxaliplatin-Containing RegimensThe recommended dosage of XELODA is 1,000 mg/m2orally twice daily for the first 14 days of each 21-day cycle for a maximum of 8 cycles in combination with oxaliplatin 130 mg/m2administered intravenously on day 1 of each cycle.Refer to the oxaliplatin prescribing information for additional dosing information as appropriate.Perioperative Treatment of Rectal CancerThe recommended dosage of capecitabine is 825 mg/m2orally twice daily when administered with concomitant radiation therapy and 1,250 mg/m2orally twice daily when administered without radiation therapy as part of a peri-operative combination regimen.Unresectable or Metastatic Colorectal CancerSingle AgentThe recommended dosage of XELODA is 1,250 mg/m2orally twice daily for the first 14 days of a 21-day cycle until disease progression or unacceptable toxicity.In Combination with OxaliplatinThe recommended dosage of XELODA is 1,000 mg/m2orally twice daily for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity in combination with oxaliplatin 130 mg/m2administered intravenously on day 1 of each cycle.Refer to the Prescribing Information for oxaliplatin for additional dosing information as appropriate. - Without Radiation Therapy: 1,250 mg/m2 orally twice daily ()
2.1 Recommended Dosage for Colorectal CancerAdjuvant Treatment of Colon CancerSingle AgentThe recommended dosage of XELODA is 1,250 mg/m2orally twice daily for the first 14 days of each 21-day cycle for a maximum of 8 cycles.In Combination with Oxaliplatin-Containing RegimensThe recommended dosage of XELODA is 1,000 mg/m2orally twice daily for the first 14 days of each 21-day cycle for a maximum of 8 cycles in combination with oxaliplatin 130 mg/m2administered intravenously on day 1 of each cycle.Refer to the oxaliplatin prescribing information for additional dosing information as appropriate.Perioperative Treatment of Rectal CancerThe recommended dosage of capecitabine is 825 mg/m2orally twice daily when administered with concomitant radiation therapy and 1,250 mg/m2orally twice daily when administered without radiation therapy as part of a peri-operative combination regimen.Unresectable or Metastatic Colorectal CancerSingle AgentThe recommended dosage of XELODA is 1,250 mg/m2orally twice daily for the first 14 days of a 21-day cycle until disease progression or unacceptable toxicity.In Combination with OxaliplatinThe recommended dosage of XELODA is 1,000 mg/m2orally twice daily for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity in combination with oxaliplatin 130 mg/m2administered intravenously on day 1 of each cycle.Refer to the Prescribing Information for oxaliplatin for additional dosing information as appropriate.
Unresectable or Metastatic Colorectal Cancer:
- Single agent: 1,250 mg/m2 twice daily orally for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity. ()
2.1 Recommended Dosage for Colorectal CancerAdjuvant Treatment of Colon CancerSingle AgentThe recommended dosage of XELODA is 1,250 mg/m2orally twice daily for the first 14 days of each 21-day cycle for a maximum of 8 cycles.In Combination with Oxaliplatin-Containing RegimensThe recommended dosage of XELODA is 1,000 mg/m2orally twice daily for the first 14 days of each 21-day cycle for a maximum of 8 cycles in combination with oxaliplatin 130 mg/m2administered intravenously on day 1 of each cycle.Refer to the oxaliplatin prescribing information for additional dosing information as appropriate.Perioperative Treatment of Rectal CancerThe recommended dosage of capecitabine is 825 mg/m2orally twice daily when administered with concomitant radiation therapy and 1,250 mg/m2orally twice daily when administered without radiation therapy as part of a peri-operative combination regimen.Unresectable or Metastatic Colorectal CancerSingle AgentThe recommended dosage of XELODA is 1,250 mg/m2orally twice daily for the first 14 days of a 21-day cycle until disease progression or unacceptable toxicity.In Combination with OxaliplatinThe recommended dosage of XELODA is 1,000 mg/m2orally twice daily for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity in combination with oxaliplatin 130 mg/m2administered intravenously on day 1 of each cycle.Refer to the Prescribing Information for oxaliplatin for additional dosing information as appropriate. - In Combination with Oxaliplatin: 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. ()
2.1 Recommended Dosage for Colorectal CancerAdjuvant Treatment of Colon CancerSingle AgentThe recommended dosage of XELODA is 1,250 mg/m2orally twice daily for the first 14 days of each 21-day cycle for a maximum of 8 cycles.In Combination with Oxaliplatin-Containing RegimensThe recommended dosage of XELODA is 1,000 mg/m2orally twice daily for the first 14 days of each 21-day cycle for a maximum of 8 cycles in combination with oxaliplatin 130 mg/m2administered intravenously on day 1 of each cycle.Refer to the oxaliplatin prescribing information for additional dosing information as appropriate.Perioperative Treatment of Rectal CancerThe recommended dosage of capecitabine is 825 mg/m2orally twice daily when administered with concomitant radiation therapy and 1,250 mg/m2orally twice daily when administered without radiation therapy as part of a peri-operative combination regimen.Unresectable or Metastatic Colorectal CancerSingle AgentThe recommended dosage of XELODA is 1,250 mg/m2orally twice daily for the first 14 days of a 21-day cycle until disease progression or unacceptable toxicity.In Combination with OxaliplatinThe recommended dosage of XELODA is 1,000 mg/m2orally twice daily for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity in combination with oxaliplatin 130 mg/m2administered intravenously on day 1 of each cycle.Refer to the Prescribing Information for oxaliplatin for additional dosing information as appropriate.
Advanced or Metastatic Breast Cancer:
- Single agent: 1,000 mg/m2 or 1,250 mg/m2 twice daily orally for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity. ()
2.2 Recommended Dosage for Breast CancerAdvanced or Metastatic Breast CancerSingle AgentThe recommended dosage of XELODA is 1,000 mg/m2or 1,250 mg/m2orally 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 DocetaxelThe recommended dosage of XELODA is 1,000 mg/m2or 1,250 mg/m2orally twice daily for the first 14 days of a 21-day cycle until disease progression or unacceptable toxicity in combination with docetaxel 75 mg/m2administered intravenously on day 1 of each cycle.Refer to the Prescribing Information for docetaxel for additional dosing information as appropriate. - In combination with docetaxel: 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 at 75 mg/m2 administered intravenously on day 1 of each cycle ()
2.2 Recommended Dosage for Breast CancerAdvanced or Metastatic Breast CancerSingle AgentThe recommended dosage of XELODA is 1,000 mg/m2or 1,250 mg/m2orally 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 DocetaxelThe recommended dosage of XELODA is 1,000 mg/m2or 1,250 mg/m2orally twice daily for the first 14 days of a 21-day cycle until disease progression or unacceptable toxicity in combination with docetaxel 75 mg/m2administered intravenously on day 1 of each cycle.Refer to the Prescribing Information for docetaxel for additional dosing information as appropriate.
Unresectable or Metastatic Gastric, Esophageal, or Gastroesophageal Junction Cancer
- 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. ()
2.3 Recommended Dosage for Gastric, Esophageal, or Gastroesophageal Junction CancerThe recommended dosage of XELODA for unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer is:- 625 mg/m2orally 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/m2or 1,000 mg/m2orally twice daily for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity in combination with oxaliplatin 130 mg/m2administered 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/m2orally 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.
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. ()
2.3 Recommended Dosage for Gastric, Esophageal, or Gastroesophageal Junction CancerThe recommended dosage of XELODA for unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer is:- 625 mg/m2orally 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/m2or 1,000 mg/m2orally twice daily for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity in combination with oxaliplatin 130 mg/m2administered 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/m2orally 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.
HER2-overexpressing metastatic adenocarcinoma of the gastroesophageal junction or stomach
- 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. ()
2.3 Recommended Dosage for Gastric, Esophageal, or Gastroesophageal Junction CancerThe recommended dosage of XELODA for unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer is:- 625 mg/m2orally 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/m2or 1,000 mg/m2orally twice daily for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity in combination with oxaliplatin 130 mg/m2administered 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/m2orally 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.
Pancreatic cancer
- 830 mg/m2 orally twice daily for the first 21 days of each 28-day cycle for maximum of 6 cycles in combination with gemcitabine 1,000 mg/m2 administered intravenously on days 1, 8, and 15 of each cycle. ()
2.4 Recommended Dosage for Pancreatic CancerThe recommended dosage of XELODA is 830 mg/m2orally 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/m2administered intravenously on days 1, 8, and 15 of each cycle.Refer to Prescribing Information for gemcitabine for additional dosing information as appropriate.
Refer to Sections 2.5 and 2.6 for information related to dosage modifications for adverse reactions and renal impairment (
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.
Severity | Dosage Modification | Resume at Same or Reduced Dose (Percent of Current Dose) |
|---|---|---|
Grade 2 | ||
1st appearance | Withhold until resolved to grade 0-1. | 100% |
2nd appearance | 75% | |
3rd appearance | 50% | |
4th appearance | Permanently discontinue. | - |
Grade 3 | ||
1st appearance | Withhold until resolved to grade 0-1. | 75% |
2nd appearance | 50% | |
3rd appearance | Permanently discontinue. | - |
Grade 4 | ||
1st appearance | Permanently discontinue OR Withhold until resolved to grade 0-1. | 50% |
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
[see Warnings and Precautions (5.10)].
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)
[see Use in Specific Populations (8.6)]
.Tablets, film-coated:
- 150 mg: biconvex, oblong, light-peach colored, with "XELODA" on one side and "150" on the other
- 500 mg: biconvex, oblong, peach colored, with "XELODA on one side and "500" on the other
- Lactation:Advise not to breastfeed. ()
8.2 LactationRisk SummaryThere is no information regarding the presence of capecitabine or its metabolites in human milk, or on its effects on milk production or the breastfed child. Capecitabine metabolites were present in the milk of lactating mice
(see Data). Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with XELODA and for 1 week after the last dose.DataLactating mice given a single oral dose of capecitabine excreted significant amounts of capecitabine metabolites into the milk.
- Hepatic Impairment:Monitor patients with hepatic impairment more frequently for adverse reactions. ()
8.7 Hepatic ImpairmentThe exposure of capecitabine increases in patients with mild to moderate hepatic impairment. The effect of severe hepatic impairment on the safety and pharmacokinetics of XELODA is unknown
[see Clinical Pharmacology (12.3)].Monitor patients with hepatic impairment more frequently for adverse reactions.
We receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available