INDICATION
XELODA is used to treat:
- cancer of the colon after surgery
- cancer of the colon or rectum (colorectal cancer) that has spread to other parts of the body (metastatic colorectal cancer). You should know that in studies, other medicines showed improved survival when they were taken together with 5-FU and leucovorin. In studies, XELODA was no worse than 5-FU and leucovorin taken together but did not improve survival compared to these two medicines
- breast cancer that has spread to other parts of the body (metastatic breast cancer) together with another medicine called Taxotere® (docetaxel)
- breast cancer that has spread to other parts of the body and has not improved after treatment with other medicines such as paclitaxel and anthracycline-containing medicine such as Adriamycin® (doxorubicin)
WARNING
For patients receiving XELODA and warfarin concomitantly, frequent monitoring
of INR or prothrombin time (PT) is recommended. A clinically important drug
interaction between XELODA and warfarin has been demonstrated. Altered
coagulation parameters and/or bleeding and death have been reported. Clinically
significant increases in PT and INR have been observed within days to months
after starting XELODA, and infrequently within one month of stopping XELODA.
These events occurred in patients with and without liver metastases. Age
greater than 60 and a diagnosis of cancer independently predispose patients to
an increased risk of coagulopathy.
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.
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), neutropenia (13;46), pain (12;10), back pain (10;9), headache (10;7), gastrointestinal motility 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), nausea (53), fatigue (41), dermatitis (37), vomiting (37), neutropenia (26), 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.
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 hand-foot 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), andneutropenia(<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), neutropenia (13;46), pain (12;10), back pain (10;9), headache (10;7), gastrointestinal motility 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), nausea (53), fatigue (41), dermatitis (37), vomiting (37), neutropenia (26), 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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