INDICATION
XELODA is used to treat:
IMPORTANT SAFETY INFORMATION
XELODA is contraindicated in patients with known hypersensitivity to capecitabine or to any of its components or to 5-fluorouracil. XELODA is contraindicated in patients with known dihydropyrimidine dehydrogenase (DPD) deficiency.

XELODA is contraindicated in patients with severe renal impairment. Patients with mild or moderate renal impairment at baseline should be carefully monitored for adverse events. Patients with moderate renal impairment at baseline require a reduced starting dose.

XELODA can induce diarrhea, sometimes severe. Patients with severe diarrhea should be carefully monitored and given fluid and electrolyte replacement if they become dehydrated.

If an adverse event of grade 2, 3, or 4 occurs (eg, diarrhea), administration of XELODA should be immediately interrupted until the adverse event resolves or decreases in intensity to grade 1. Following a grade 2 reoccurrence of the adverse event or occurrence of any other grade 3 or 4 adverse event, subsequent doses of XELODA should be decreased. Please consult XELODA Prescribing Information (DOSAGE AND ADMINISTRATION.) for recommended dose modifications for management of adverse events.

Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with XELODA. Men should use birth control while taking XELODA. Women should not nurse when receiving XELODA therapy.

The addition of leucovorin to XELODA is not recommended. There was no apparent advantage in response rate by adding leucovorin to XELODA; however, toxicity was increased.

Cardiotoxicity has been observed with XELODA, including myocardial infarction/ischemia, angina, dysrhythmias, cardiac arrest, cardiac failure, sudden death, electrocardiographic changes, and cardiomyopathy. These adverse events may be more common in patients with a prior history of coronary artery disease.

Care should be exercised when XELODA is coadministered with CYP2X9 substrates.

The level of phenytoin should be carefully monitored in patients taking XELODA and the dose of phenytoin may need to be reduced.

If drug-related grade 2 to 4 elevations in bilirubin occur, administration of XELODA should be immediately interrupted until the hyperbilirubinemia resolves or decreases in intensity to grade 1.

ADVERSE EVENTS
In XELODA monotherapy for colon cancer in the adjuvant setting, the most common adverse events for all grades (≥10%) in patients receiving either XELODA or 5-FU/LV (%;%) were handfoot syndrome (60;9), diarrhea (47;65), nausea (34;47), stomatitis (22;60), fatigue (16;16), lethargy (16;15), vomiting (15;21), abdominal pain (14;16), asthenia (10;10), anorexia (9;11), constipation (9;11), and alopecia (6;22). Grade 3/4 adverse events (≥5%) in patients receiving either XELODA or 5-FU/LV were hand-foot syndrome (17;<1), diarrhea (12;14), stomatitis (2;14), and neutropenia (<1;5).

In XELODA monotherapy for metastatic colorectal cancer, the most common adverse events (≥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 decrease (26;31), stomatitis (25;62), pyrexia (18;21), edema (15;9), constipation (14;17), dyspnea (14;10), disorder (10;7), oral discomfort (10;10), upper GI inflammatory disorders (8;10), peripheral sensory neuropathy (10;4), taste disturbance (6;11), and eye irritation (13;10). Grade 3/4 adverse events (≥5%) in 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).

In XELODA monotherapy for metastatic breast cancer, the most common adverse events (≥10%) in patients receiving XELODA (%) were lymphopenia (94), anemia (72), diarrhea (57), hand-foot syndrome (57), stomatitis (24), thrombocytopenia (24), anorexia (23), hyperbilirubinemia (22), paresthesia (21), abdominal pain (20), constipation (15), eye irritation (15), and pyrexia (12). Grade 3/4 adverse events (≥5%) in patients receiving XELODA were lymphopenia (59), diarrhea (15), hand-foot syndrome (11), hyperbilirubinemia (11), fatigue (8), stomatitis (7), and dehydration (5).

In XELODA combination therapy (XELODA plus docetaxel) for breast cancer, the most common adverse events (≥10%) in patients receiving either XELODA plus docetaxel or docetaxel alone (%;%) were lymphocytopenia (99;98), leukopenia (91;88), neutropenia/granulocytopenia (86;87), anemia (80;83), diarrhea (67;48), stomatitis (67;43), hand-foot syndrome (63;8), nausea (45;36), alopecia (41;42), thrombocytopenia (41;23), vomiting (35;24), edema (33;34), abdominal pain (30;24), pyrexia (28;34), asthenia (26;25), fatigue (22;27), constipation (20;18), hyperbilirubinemia (20;6), neutropenic fever (16;21), taste disturbance (16;14), weakness (16;11), arthralgia (15;24), headache (15;15), myalgia (15;25), dyspnea (14;16), dyspepsia (14;8), nail disorder (14;15), anorexia (13;11), cough (13;22), pain in limb (13;13), back pain (12;11), dizziness (12;8), lacrimation increase (12;7), paresthesia (12;16), sore throat (12;11), appetite decrease (10;5), dehydration (10;7), bone pain (8;10), dermatitis (8;11), insomnia (8;10), and peripheral neuropathy (6;10). Grade 3/4 adverse events (≥5%) in patients receiving XELODA plus docetaxel or docetaxel alone (%;%) were lymphocytopenia (89;84), leukopenia (61;75), neutropenia/ granulocytopenia (69;76), hand-foot syndrome (24;1), stomatitis (18;5), neutropenic fever (16;21), diarrhea (15;6), anemia (10;6), hyperbilirubinemia (9;4), nausea (7;2), alopecia (6;7), vomiting (5;2), asthenia (5;6), and fatigue (4;6).

Please see XELODA Prescribing Information for indications and usage, contraindications, warnings including boxed WARNING, precautions, and adverse reactions.

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