Capecitabine
CAPECITABINE- capecitabine tablet
Dr. Reddy’s Laboratories Limited
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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 c apecitabine tablets 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 capecitabine tablets was introduced. These events occurred within several days and up to several months after initiating capecitabine tablets and, in a few cases, within 1 month after stopping capecitabine tablets. 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
Capecitabine tablets are 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
Capecitabine tablets are indicated for the:
• treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline- or taxanecontaining 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
Capecitabine tablets are 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
Capecitabine tablets are 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 capecitabine tablets 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 capecitabine tablets 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 capecitabine tablets 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 capecitabine tablets 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 capecitabine tablets 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 capecitabine tablets based on patient risk factors and adverse reaction
In Combination with Docetaxel
The recommended dosage of capecitabine tablets 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 capecitabine tablets 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 capecitabine tablets based on patient risk factors and adverse reactions.
The recommended dosage of capecitabine tablets 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 capecitabine tablets 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 capecitabine tablets as described in Table 1. Do not replace missed doses of capecitabine tablets; instead resume capecitabine tablets with the next planned dosage.
When capecitabine tablets is administered with docetaxel, withhold capecitabine tablets and docetaxel until the requirements for resuming both capecitabine tablets 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 Sameor Reduced Dose (Percentof 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 | Withholduntil 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)].
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