You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Genentech at (888) 835-2555.
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 of 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 in combination with docetaxel is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy.
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, e.g., 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.
Patients receiving concomitant capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored frequently in order to adjust the anticoagulant dose accordingly. A clinically important Xeloda-warfarin drug interaction was demonstrated in a clinical pharmacology trial. Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking Xeloda concomitantly with coumarin-derivative anticoagulants such as warfarin and phenprocoumon. Postmarketing reports have shown clinically significant increases in prothrombin time (PT) and INR in patients who were stabilized on anticoagulants at the time Xeloda was introduced. These events occurred within several days and up to several months after initiating Xeloda therapy and, in a few cases, within 1 month after 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.
Severe Renal Impairment
Xeloda is contraindicated in patients with severe renal impairment (creatinine clearance below 30 mL/muin [Cockroft and Gault]).
Xeloda is contraindicated in patients with known hypersensitivity to capecitabine or to any of its components or to 5-fluorouracil.
Warnings and Precautions
The most common adverse reactions (³30%) with Xeloda were diarrhea, hand-and-foot syndrome, nausea, vomiting, abdominal pain, fatigue/weakness, and hyperbilirubinemia. Other adverse reactions, including serious adverse reactions, have been reported.
Use in Specific Populations
Based on findings in animal reproduction studies and its mechanism of action, Xeloda can cause fetal harm when administered to a pregnant woman. Limited available human data are not sufficient to inform the drug-associated risk during pregnancy. Apprise pregnant women of the potential risk to a fetus.
Advise females not to breastfeed during treatment with Xeloda and for 2 weeks after the last dose.
Females and Males of Reproductive Potential
Pregnancy testing is recommended for females of reproductive potential prior to initiating Xeloda.
Xeloda can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the final dose of Xeloda.
Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months following the last dose of Xeloda.
Based on animal studies, Xeloda may impair fertility in females and males of reproductive potential.
The safety and effectiveness of Xeloda in pediatric patients have not been established.
Physicians should pay particular attention to monitoring the adverse effects of Xeloda in the elderly.
Exercise caution when patients with mild to moderate hepatic dysfunction due to liver metastases are treated with Xeloda. The effect of severe hepatic dysfunction on Xeloda is not known.
Patients with moderate (creatinine clearance = 30 to 50 mL/min) and severe (creatinine clearance