Capecitabine Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Breast Cancer

For use in 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.)

The recommended dose of capecitabine is 1,250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2,500 mg/m2 total daily dose) for 2 weeks followed by a 1 week rest period given as 3 week cycles. Capecitabine tablets should be swallowed with water within 30 minutes after a meal.

Alternatively, a dose of 1,000 mg/m2 administered orally twice daily (morning and evening; equivalent to 2,000 mg/m2 total daily dose) for 2 weeks with 1 week rest may be may be appropriate.

Usual Adult Dose for Colorectal Cancer

For use as first line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred:

Recommended dose: 1,250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2,500 mg/m2 total daily dose) for 2 weeks followed by a 1 week rest period given as 3 week cycles. Capecitabine tablets should be swallowed with water within 30 minutes after a meal.
Alternate dose: 1,000 mg/m2 administered orally twice daily (morning and evening; equivalent to 2,000 mg/m2 total daily dose) for 2 weeks with 1 week rest may be may be appropriate.

For use as adjuvant treatment in patients with Dukes' C colon cancer:

Recommended dose: 1,250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2,500 mg/m2 total daily dose) for 2 weeks followed by a 1 week rest period given as 3 week cycles for a total of 8 cycles (24 weeks). Capecitabine tablets should be swallowed with water within 30 minutes after a meal.

Renal Dose Adjustments

No adjustment to the starting dose of capecitabine is recommended in patients with mild renal impairment (creatinine clearance = 51 to 80 mL/min).

In patients with moderate renal impairment (baseline creatinine clearance = 30 to 50 mL/min), a dose reduction to 75% of the capecitabine starting dose (from 1,250 mg/m2 to 950 mg/m2 twice daily) is recommended.

Capecitabine is contraindicated in patients with severe renal impairment (creatinine clearance below 30 mL/min).

Liver Dose Adjustments

In patients with mild to moderate hepatic dysfunction due to liver metastases, no starting dose adjustment is necessary. However, patients should be monitored carefully.

The effect of severe hepatic dysfunction on capecitabine is not known

Dose Adjustments

Dosage modifications are not recommended for grade 1 events. Therapy with capecitabine should be interrupted upon the occurrence of a grade 2 or 3 adverse experience. Once the adverse event has resolved or decreased in intensity to grade 1, then capecitabine therapy may be restarted at full dose or as adjusted according to the following:

Grade 2: 1st appearance: Interrupt until resolved to grade 0-1, then begin the next cycle at 100% of the starting dose;

Grade 2: 2nd appearance: Interrupt until resolved to grade 0-1, then begin the next cycle at 75% of the starting dose.

Grade 2: 3rd appearance: Interrupt until resolved to grade 0-1, then begin the next cycle at 50% of the starting dose.

Grade 2: 4th appearance: Discontinue treatment permanently.

Grade 3: 1st appearance: Interrupt until resolved to grade 0-1 then begin the next cycle at 75% of the starting dose.

Grade 3: 2nd appearance: Interrupt until resolved to grade 0-1 then begin the next cycle at 50% of the starting dose.

Grade 3: 3rd appearance: Discontinue treatment permanently.

Grade 4: 1st appearance: Discontinue treatment permanently or if the physician deems it to be in the patient's best interest to continue, interrupt until resolved to grade 0-1, then begin the next cycle at 50% of the starting dose.

Doses of capecitabine omitted for toxicity are not replaced or restored; instead the patient should resume the planned treatment cycles.

Precautions

Capecitabine can induce diarrhea which may be severe. Patients with severe diarrhea should be carefully monitored and given fluid and electrolyte replacement if they become dehydrated. Standard antidiarrheal treatments (e.g., loperamide) are recommended. Depending on the severity of the diarrhea, treatment may need to be interrupted followed by a decrease in dosage when treatment is resumed.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available.

Other Comments

Capecitabine is an orally administered systemic prodrug of 5'-deoxy-5-fluorouridine which is converted to 5-fluorouracil.

The breast cancer indication is based on demonstration of a response rate. No results are available from controlled trials that demonstrate a clinical benefit resulting from treatment, such as improvement in disease related symptoms, disease progression or survival.

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