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Xeloda
PREGNANCY CATEGORY D
Drug Classes
Antimetabolite
Antineoplastic
Therapeutic Actions
A prodrug of 5-fluorouridine that is readily converted to 5-FU; inhibits thymidylate synthetase, leading to inhibition of DNA and RNA synthesis and cell death.
Indications
Treatment of breast cancer in patients with metastatic breast cancer resistant to both paclitaxel and doxorubicin or doxorubicin-equivalent chemotherapy
Treatment of breast cancer in combination with docetaxel in patients with metastatic disease after failure with anthracycline chemotherapy
Treatment of metastatic colorectal cancer as first-time treatment when treatment with fluoropyrimidine therapy is preferred
Adjuvant post-surgery treatment of patients with Dukes C colon cancer who have undergone complete resection of the primary tumor who are candidates for single oral agent chemotherapy
Unlabeled uses: Adjunct treatment of pancreatic cancer; with lopatinib for treatment of advanced or metastatic breast cancer in women with HER 2-overexpressing tumors previously treated with anthracycline and trastuzumab; with ixabepilone for advanced or metastatic breast cancer in women treated with anthracycline and ataxane
Contraindications and Cautions
Contraindicated with allergy to 5-FU; pregnancy; lactation; severe renal impairment, concomitant warfarin therapy.
Use cautiously with renal or hepatic impairment, severe diarrhea or intestinal disease, coronary artery disease, bleeding disorders (adverse cardiac effects are more common).
Available Forms
Tablets—150, 500 mg
Dosages
Adults
Breast and colorectal cancers: Starting dose, 2,500 mg/m2/day PO in two divided doses 12 hr apart within 30 min after a meal for 2 wk followed by a 1-wk rest period; given in 3-wk cycles.
Adjuvant post-surgery Dukes C colon cancer: 1,250 mg/m2 PO twice daily, morning and evening within 30 min after a meal, for 2 wk, followed by 1 wk rest, given as 3-wk cycles for a total of 8 cycles (24 wk).
Pediatric patients
Safety and efficacy not established.
Geriatric patients or patients with hepatic impairment
These patients may be more sensitive to the toxic effects of the drug. Monitor closely and decrease dosage as needed to avoid toxicity.
Patients with renal impairment

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