Xelodace DT 500mg Tablet

Capecitabine tablet 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. 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. 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. 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. Abridged from the full prescribing information.

---

Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Boxed warning. SERIOUS ADVERSE REACTIONS OR DEATH IN PATIENTS WITH COMPLETE DPD DEFICIENCY and BLEEDING WITH CONCOMITANT USE OF VITAMIN K ANTAGONISTS Increased risk of serious adverse reactions or death in patients with complete DPD deficiency Test patients for genetic variants of DPYD prior to initiating Capecitabine tablets unless immediate treatment is necessary. Avoid use of Capecitabine tablets in patients with certain homozygous or compound heterozygous DPYD variants that result in complete DPD deficiency. 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. 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 in patients with and without liver metastases. Monitor INR more frequently and adjust the dose of the vitamin K antagonist as appropriate. WARNING: SERIOUS ADVERSE REACTIONS OR DEATH IN PATIENTS WITH COMPLETE DPD DEFICIENCY and BLEEDING WITH CONCOMITANT USE OF VITAMIN K ANTAGONISTS See full prescribing information for complete boxed warning. Serious adverse reactions or death may occur in patients with complete DPD deficiency. Test patients for genetic variants of DPYD prior to initiating Capecitabine tablets unless immediate treatment is necessary. Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking Capecitabine tablets concomitantly with oral vitamin K antagonists. Monitor international normalized ratio (INR) more frequently and adjust the dose of the vitamin K antagonist as appropriate. - Cardiotoxicity: May be more common in patients with a prior history of coronary artery disease. Withhold Capecitabine tablets for cardiotoxicity as appropriate. The safety of resumption of Capecitabine tablets in patients with cardiotoxicity that has resolved has not been established. - Diarrhea: Withhold Capecitabine tablets and then resume at same or reduced dose, or permanently discontinue, based on severity and occurrence. - Dehydration: Optimize hydration before starting Capecitabine tablets. Monitor hydration status and kidney function at baseline and as clinically indicated. Withhold Capecitabine tablets and then resume at same or reduced dose, or permanently discontinue, based on severity and occurrence. - Renal Toxicity: Monitor renal function at baseline and as clinically indicated. Optimize hydration before starting Capecitabine tablets. Abridged from the full prescribing information.

---

Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following clinically significant adverse reactions are described elsewhere in the labeling: Cardiotoxicity Diarrhea Dehydration Renal Toxicity Serious Skin Toxicities Palmar-Plantar Erythrodysesthesia Syndrome Myelosuppression Hyperbilirubinemia - Most common adverse reactions in patients who received Capecitabine tablets as a single agent for the adjuvant treatment for colon cancer (>30%) were palmar-plantar erythrodysesthesia syndrome, diarrhea, and nausea. - Most common adverse reactions (>30%) in patients with metastatic colorectal cancer who received Capecitabine tablets as a single agent were anemia, diarrhea, palmar-plantar erythrodysesthesia syndrome, hyperbilirubinemia, nausea, fatigue, and abdominal pain. - Most common adverse reactions (>30%) in patients with metastatic breast cancer who received Capecitabine tablets with docetaxel were diarrhea, stomatitis, palmar-plantar erythrodysesthesia syndrome, nausea, alopecia, vomiting, edema, and abdominal pain. - Most common adverse reactions (>30%) in patients with metastatic breast cancer who received Capecitabine tablets as a single agent were lymphopenia, anemia, diarrhea, handand- foot syndrome, nausea, fatigue, vomiting, and dermatitis. Reddy’s Laboratories Inc. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adjuvant Treatment of Colon Cancer Single Agent The safety of Capecitabine tablets as a single agent was evaluated in patients with Stage III colon cancer in X-ACT. Patients receivedcapecitabine tablets 1,250 mg/m 2 orally twice daily for the first 14 days of a 21-day cycle (N=995) or leucovorin 20 mg/m 2 intravenously followed by fluorouracil 425 mg/m 2 as an intravenous bolus on days 1 to 5 of each 28-day cycle (N=974). Among patients who received Capecitabine tablets, the median duration of treatment was 5.4 months. Deaths due to all causes occurred in 0.8% of patients who received Capecitabine tablets on study or within 28 days of receiving study drug. Permanent discontinuation due to an adverse reaction occurred in 11% of patients who received Capecitabine tablets. Most common adverse reactions (>30%) were palmar-plantar erythrodysesthesia syndrome, diarrhea, and nausea. Tables 2 and 3 summarize the adverse reactions and laboratory abnormalities in X-ACT. Abridged from the full prescribing information.

---

Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.