Xeloda (Capecitabine)

Breast cancer treatment Xeloda (Capecitabine) is indicated as first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred. Combination chemotherapy has shown a survival benefit compared to 5-FU/LV alone. A survival benefit over 5-FU/LV has not been demonstrated with Xeloda breast cancer treatment monotherapy. Use of Xeloda (Capecitabine) breast cancer treatment instead of 5-FU/LV in combinations has not been adequately studied to assure safety or preservation of the survival advantage. Xeloda (Capecitabine) in combination with docetaxel is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy. Xeloda (Capecitabine) monotherapy is also indicated for the treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated, eg, patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents. Resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse within 6 months of completing treatment with an anthracycline-containing adjuvant regimen.

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Xeloda breast cancer treatment is contraindicated in patients who have a known hypersensitivity to capecitabine or to any of its components or to 5-fluorouracil otherwise it may result in Xeloda side effects. Xeloda is contraindicated in patients with known dihydropyrimidine dehydrogenase (DPD) deficiency otherwise it may result in Xeloda side effects. Xeloda is also contraindicated in patients with severe renal impairment otherwise it results in Xeloda side effects. Patients with moderate renal impairment require dose reduction. Xeloda can induce Xeloda side effects like diarrhea, sometimes severe. Patients with severe diarrhea should be carefully monitored. Patients >= 80 years old receiving Xeloda monotherapy, and patients >= 60 years old receiving Xeloda in combination with docetaxel, may experience a greater incidence of grade 3 or 4 Xeloda side effects. Xeloda may cause Xeloda side effects like fetal harm when given to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Xeloda. In Xeloda monotherapy for metastatic colorectal cancer, the most common Xeloda side effects(>=10%) in patients receiving either Xeloda or 5-FU/LV (%; %) were anemia (80; 79), diarrhea (55; 61), hand-foot syndrome (54; 6), hyperbilirubinemia (48; 17), nausea(43; 51), fatigue/ weakness (42; 46), abdominal pain (35; 31), dermatitis (27; 26), vomiting (27; 30), appetite decreased (26; 31), stomatitis (25; 62), pyrexia (18; 21), edema (15; 9), constipation (14; 17), dyspnea (14; 10), neutropenia (13; 46), pain (12; 10), back pain (10; 9), and headache (10; 7). Grade 3/4 Xeloda side effects (>=5%) in patients receiving either Xeloda or 5-FU/LV (Xeloda G3/4; 5-FU/LV G3/4) were hyperbilirubinemia (23: 6), hand-foot syndrome (17; 1), diarrhea (15; 12), abdominal pain (10; 5), vomiting (5; 5), ileus (5; 3), stomatitis (3; 15), and neutropenia (3; 21). In Xeloda monotherapy for metastatic breast cancer, the most common Xeloda side effects(>=10%) were lymphopenia (94), anemia (72), diarrhea (57), hand-foot syndrome (57), nausea (53), fatigue (41), vomiting (37), dermatitis (37), neutropenia (26), thrombocytopenia (24), stomatitis (24), anorexia (23), hyperbilirubinemia (22), paresthesia (21), abdominal pain (20), eye irritation (15), constipation (15), and pyrexia(12). In combination therapy with Xeloda and docetaxel for metastatic breast cancer, the most common Xeloda side effects (>=10%) were lymphocytopenia (99), leukopenia (91), neutropenia/ granulocytopenia (86), anemia (80), diarrhea (67), stomatitis (67), hand-foot syndrome (63), nausea (45), alopecia (41), thrombocytopenia (41), vomiting (35), edema (33), abdominal pain (30), pyrexia (28), asthenia (26), fatigue (22), constipation (20), hyperbilirubinemia (20), neutropenic fever (16), weakness (16), taste disturbance (16), headache (15), arthralgia (15), myalgia (15), dyspepsia (14), nail disorder (14), dyspnea(14), pain in limb (13), anorexia (13), cough (13), back pain (12), dizziness (12), paresthesia (12), lacrimation increased (12), sore throat (12), appetite decreased (10), and dehydration (10).