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Capegard Structure

- 500mg - Capecitabine.

Capegard Indications


Colorectal Cancer
Capegard 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. Capegard was non-inferior to 5-fluorouracil and leucovorin (5-FU/LV) for disease-free survival (DFS). Although neither Capegard nor combination chemotherapy prolongs overall survival (OS), combination chemotherapy has been demonstrated to improve disease-free survival compared to 5-FU/LV. Physicians should consider these results when prescribing single-agent Capegard in the adjuvant treatment of Dukes` C colon cancer.

Capegard 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 Capegard monotherapy. Use of Capegard instead of 5-FU/LV in combinations has not been adequately studied to assure safety or preservation of the survival advantage.

Breast Cancer
Capegard in combination with docetaxel is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy.

Capegard monotherapy is also 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/m 2 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.

Capegard Dosage

Capegard recommended dosage of Capegard is 1250 mg/m 2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m 2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3-week cycles. Capegard tablets should be swallowed with water within 30 minutes after a meal. In combination with docetaxel, the recommended dose of Capegard is 1250 mg/m 2 twice daily for 2 weeks followed by a 1-week rest period, combined with docetaxel at 75 mg/m 2 as a 1-hour intravenous infusion every 3 weeks. Pre-medication, according to the docetaxel labeling, should be started prior to docetaxel administration for patients receiving the Capegard plus docetaxel combination.

Adjuvant treatment in patients with Dukes` C colon cancer is recommended for a total of 6 months, ie, Capegard 1250 mg/m 2 orally twice daily for 2 weeks followed by a 1-week rest period, given as 3-week cycles for a total of 8 cycles (24 weeks).

Capegard Contraindications

Capegard is contraindicated in patients:
- with severe renal impairment (creatinine clearance below 30 mL/min [Cockroft and Gault]);
- with known dihydropyrimidine dehydrogenase (DPD) deficiency;
- who have a known hypersensitivity to 5-fluorouracil;
- with known hypersensitivity to Capegard or to any of its components;

Capegard Form

Blister strip of 10 tablets.


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