Celabin Dosage/Direction for Use

Capecitabine is intended for long term administration unless clinically inappropriate. Capecitabine tablets should be swallowed whole with water within 30 minutes after a meal. Do not crush or cut capecitabine tablet. If progressive disease or intolerable toxicity is observed, treatment with capecitabine should be discontinued. The standard and reduced dose of capecitabine is calculated according to body surface area (see Table 1 and 2).
Patients with baseline neutrophil counts of <1.5 x 10⁹/L and/or thrombocyte counts of <100 x 10⁹/L should not be treated with capecitabine. If unscheduled laboratory assessments during a treatment cycle show that the neutrophil count drops below 1.0 x 10⁹/L or that the platelet count drops below 75 x 10⁹/L, treatment with capecitabine should be interrupted.
Patients should be carefully monitored for toxicity and doses of capecitabine should be modified as necessary to accommodate individual patient tolerance to treatment (see Table 3 and 4).
Monotherapy: Recommended Capecitabine Dose for Metastatic Colorectal Cancer, Adjuvant Colorectal Cancer, Metastatic Breast Cancer: 1250 mg/m² administered orally 2 times a day (morning and evening; equivalent to 2500 mg/m² total daily dose) for 2 weeks followed by 1 week rest period given for a total of 8 cycles.
Combination Therapy: Recommended Capecitabine Dose in Combination with Oxaliplatin for Metastatic Colorectal Cancer: 1000 mg/m² two times a day for 2 weeks followed by 1 week rest period.
The first dose of capecitabine is given on the evening of day 1 and the last dose is given on the morning of day 15.
Given as a 3-weekly schedule, oxaliplatin is administered as 130 mg/m² intravenous infusion over 2 hours.
Premedication to maintain adequate anti-emesis should be started prior to oxaliplatin administration for patients receiving capecitabine plus oxaliplatin combination (see oxaliplatin product information for dosage & administration).
Recommended Capecitabine Dose in Combination with Docetaxel for Metastatic Breast Cancer: 1250 mg/m² two times a day (morning and evening; equivalent to 2500 mg/m² total daily dose) for 2 weeks followed by 1 week rest period.
Docetaxel 75 mg/m² is administered as 1-hour IV infusion on the first day of each 3-week cycle.
Premedication, according to docetaxel labeling, should be started prior to docetaxel administration for patients receiving capecitabine plus docetaxel combination (see docetaxel product information for dosage & administration). (See Table 1 and 2.)

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Dose Management Guidelines: Toxicity due to capecitabine administration may be managed by symptomatic treatment and/or modification of the dose (i.e., treatment interruption, dose reduction). Once the dose has been reduced, it should not be increased at a later time. Treatment can be continued at the same dose without reduction or interruption for toxicities that are considered by the treating physician to be unlikely to become serious or life threatening (e.g., alopecia, altered taste, nail changes). Doses of capecitabine that are omitted because of toxicity are not replaced nor restored. (See Table 3).

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Monotherapy: Capecitabine dose modification scheme is recommended for the management of adverse reaction. (See Table 4).

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Combination Therapy: Dose modifications for toxicity when capecitabine is used in combination with other therapies should be made according to Table 4 previously for capecitabine and according to the appropriate product information for the other agent/s.
If a treatment delay is indicated for either capecitabine or the other agent/s at the beginning of a treatment cycle, then administration of all agents should be delayed until the requirements for starting all drugs are met. On the other hand, if the treating physician considered the toxicities not to be related to capecitabine during a treatment cycle, capecitabine should be continued and the dose of the other agent adjusted accordingly.
If the other agent/s have to be discontinued permanently, then capecitabine treatment can be resumed when the requirements for restarting capecitabine are met. (See Table 5).

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Adjustment of Starting Dose in Special Populations: Renal Impairment: Adjust the dose of capecitabine based on the patient's creatinine clearance (Cockroft and Gault Equation, as shown as follows) at baseline. (See equation).

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Creatinine clearance for Females = 0.85 x male value.
Creatinine clearance in SI units (mL/s) = 0.01667 x value obtained from above formula in mL/min.
The starting dose adjustment recommended for patients with moderate renal impairment apply to both capecitabine monotherapy and capecitabine in combination with docetaxel. Subsequent dose adjustment is recommended as outlined in Tables 4 and 5 (depending on the regimen) if a patient develops a grade 2 to 4 adverse event. (See Table 6).

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