Naprocap Dosage/Direction for Use

Capecitabine tablets should be swallowed whole with water within 30 minutes after a meal. Capecitabine dose is calculated according to body surface area.
Standard Starting Dose: Monotherapy (Metastatic Colorectal Cancer, Adjuvant Colorectal Cancer, Metastatic Breast Cancer): The recommended dose of Capecitabine is 1250 mg/m² administered orally twice daily (morning and evening; equivalent to 2500 mg/m² total daily dose) for 2 weeks followed by a 1-week rest period given as 3-week cycles.
Adjuvant treatment in patients with Dukes' C colon cancer is recommended for a total of 6 months [i.e., Capecitabine 1250 mg/m² 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)]. (See Table 1.)

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In Combination with Docetaxel (Metastatic Breast Cancer): In combination with docetaxel, the recommended dose of Capecitabine is 1250 mg/m² twice daily for 2 weeks followed by a 1-week rest period, combined with docetaxel at 75 mg/m² 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 Capecitabine plus docetaxel combination. Table 1 displays the total daily dose of Capecitabine by body surface area and the number of tablets to be taken at each dose.
Dose Management Guidelines: General: Capecitabine tablet dosage may need to be individualized to optimize patient management. Patients should be carefully monitored for toxicity and doses of Capecitabine should be modified as necessary to accommodate individual patient tolerance to treatment. Toxicity due to Capecitabine tablet administration may be managed by symptomatic treatment, dose interruptions and adjustment of Capecitabine dose. Once the dose has been reduced, it should not be increased at a later time. Doses of Capecitabine omitted for toxicity are not replaced or restored; instead the patient should resume the planned treatment cycles. The dose of phenytoin and the dose of coumarin-derivative anticoagulants may need to be reduced when either drug is administered concomitantly with Capecitabine Tablets.
Monotherapy (Metastatic Colorectal Cancer, Adjuvant Colorectal Cancer, Metastatic Breast Cancer): Capecitabine dose modification scheme as described in Table 2 as follows is recommended for the management of adverse reactions. (See Table 2.)

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In Combination With Docetaxel (Metastatic Breast Cancer): Dose modifications of Capecitabine for toxicity should be made according to Table 2. At the beginning of a treatment cycle, if a treatment delay is indicated for either Capecitabine or docetaxel, then administration of both agents should be delayed until the requirements for restarting both drugs are met. The dose reduction schedule for docetaxel when used in combination with Capecitabine for the treatment of metastatic breast cancer is shown in Table 3. (See Table 3.)

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Adjustment of Starting Dose in Special Populations: Renal Impairment: No adjustment to the starting dose of Capecitabine is recommended in patients with mild renal impairment (creatinine clearance=51 to 80 mL/min [Cockroft and Gault, as shown as follows]). In patients with moderate renal impairment (baseline creatinine clearance=30 to 50 mL/min), a dose reduction to 75% of the Capecitabine starting dose when used as monotherapy or in combination with docetaxel (from 1250 mg/m² to 950 mg/m² twice daily) is recommended. Subsequent dose adjustment is recommended as outlined in Table 2 and Table 3 (depending on the regimen) if a patient develops a grade 2 to 4 adverse event. The starting dose adjustment recommendations for patients with moderate renal impairment apply to both Capecitabine monotherapy and Capecitabine in combination use with Docetaxel. (See equation.)

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Geriatrics: Physicians should exercise caution in monitoring the effects of Capecitabine in the elderly. Insufficient data are available to provide a dosage recommendation.