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Pharmacy title
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Metastatic Breast Cancer, Metastatic Colorectal Cancer, and Adjuvant Colon Cancer Treatment | XELODA® (capecitabine) |
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Website
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http://www.xeloda.com
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Pharmacy description
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Official Site for XELODA(R) (capecitabine) tablets for the treatment of metastatic colorectal and breast cancer as well as adjuvant colon cancer treatment. Learn more about XELODA (capecitabine)(R) oral chemotherapy medicine.
XELODA is indicated as a single agent for adjuvant treatment in patients with Dukes' C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred. XELODA was non-inferior to 5-fluorouracil and leucovorin (5-FU/LV) for disease-free survival (DFS). Physicians should consider results of combination chemotherapy trials, which have shown improvement in DFS and OS, when prescribing single-agent XELODA in the adjuvant treatment of Dukes' C colon cancer.
XELODA 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 monotherapy. Use of XELODA instead of 5-FU/LV in combinations has not been adequately studied to assure safety or preservation of the survival advantage.
XELODA monotherapy is 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.
XELODA in combination with docetaxel is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy.
Boxed WARNING and Contraindications
Patients receiving concomitant capecitabine and oral coumarin-derivative anticoagulants such as warfarin and phenprocoumon should have their anticoagulant response (INR or prothrombin time) monitored frequently in order to adjust the anticoagulant dose accordingly. Altered coagulation parameters and/or bleeding, including death, have been reported during concomitant use.
XELODA is contraindicated in patients with known dihydropyrimidine dehydrogenase (DPD) deficiency, severe renal impairment, or known hypersensitivity to capecitabine or to any of its components or to 5-fluorouracil.
Additional Serious Adverse Reactions
Additional serious adverse reactions include diarrhea, cardiotoxicity, hand-and-foot syndrome, and hyperbilirubinemia. XELODA can cause fetal harm. Advise women of the potential risk to the fetus. Do not treat patients with neutrophil counts <1.5 x 109/L or thrombocyte counts <100x109/L.
Most Common Adverse Reactions
The most common adverse reactions (>=30%) were diarrhea, hand-and-foot syndrome, nausea, vomiting, abdominal pain, fatigue/weakness, and hyperbilirubinemia. Other adverse reactions, have been reported.
Important safety information - Monotherapy in Adjuvant Colon Cancer
In a phase 3 study of XELODA monotherapy in colon cancer in the adjuvant setting, serious adverse events (grade 3/4) occurring in >=5% of patients receiving either XELODA or 5 FU/LV (%;%) were increase in bilirubin (20;6), hand-foot syndrome (17;<1), decrease in lymphocytes (13;13), diarrhea (12;14), decrease in neutrophils/granulocytes (2;26), stomatitis (2;14), and neutropenia (<1;5).
Important safety information - Monotherapy in MCRC
In two phase 3 trials of XELODA monotherapy in metastatic colorectal cancer, serious adverse events (grade 3/4) occurring in >=5% of patients receiving either XELODA or 5 FU/LV (%;%) 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).
Important safety information - Monotherapy in MBC
In a single-arm study of XELODA monotherapy in metastatic breast cancer, serious adverse events (grade 3/4) occurring in >=5% of patients receiving XELODA (%) were lymphopenia (59), diarrhea (15), hand-foot syndrome (11), hyperbilirubinemia (11), fatigue (8), stomatitis (7), and dehydration (5).
Important safety information - Combination Therapy with Docetaxel in MBC
In a phase 3 study of XELODA combination therapy (XELODA plus docetaxel) in metastatic breast cancer, serious adverse events (grade 3/4) occurring at a >=2% higher incidence in patients receiving XELODA plus docetaxel vs. docetaxel alone (%;%) were lymphocytopenia (89;84), hand-foot syndrome (24;1), stomatitis (<18;5), diarrhea (<15;<6), anemia (10;<6), hyperbilirubinemia (9;4), nausea (7;2), vomiting (5;2), constipation (2;0), and nail disorder (2;0).
Important treatment considerations - Dose modifications
XELODA dosage may need to be individualized to optimize patient management. Patients should be carefully monitored for toxicity and doses of XELODA should be modified as necessary to accommodate individual patient tolerance to treatment. Toxicity due to XELODA administration may be managed by symptomatic treatment, dose interruptions and adjustment of XELODA dose. Once the dose has been reduced it should not be increased at a later time. Please consult XELODA Prescribing Information for recommended dose modifications.
Important treatment considerations - Women of childbearing potential
XELODA may cause fetal harm when given to a pregnant woman. There are no adequate and well-controlled studies in pregnant women using XELODA. If the drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of potential harm to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with XELODA. |
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