Xeloda: Package Insert and Label Information

XELODA- capecitabine tablet, film coated
Genentech, Inc.

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)].

1 INDICATIONS AND USAGE

1.1 Colorectal Cancer

XELODA 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.

1.2 Breast Cancer

XELODA 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.

1.3 Gastric, Esophageal, or Gastroesophageal Junction Cancer

XELODA 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.

1.4 Pancreatic Cancer

XELODA is indicated for the adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen.

2 DOSAGE AND ADMINISTRATION

2.1 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.

2.2 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.

2.3 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.

2.4 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.

2.5 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.

Table 1 Recommended Dosage Modifications for Adverse Reactions
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)].

2.6 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) [see Use in Specific Populations (8.6)].

2.7 Administration

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

3 DOSAGE FORMS AND STRENGTHS

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

4 CONTRAINDICATIONS

XELODA is contraindicated in patients with history of severe hypersensitivity reaction to fluorouracil or capecitabine [see Adverse Reactions (6.1)].

5 WARNINGS AND PRECAUTIONS

5.1 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 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)].

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