Xeltabine Dosage/Direction for Use

Colon, colorectal and breast cancer: The recommended dose of Capecitabine (Xeltabine) 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. Capecitabine (Xeltabine) tablets should be swallowed whole with water within 30 minutes after a meal.
In combination with docetaxel, the recommended dose of Capecitabine (Xeltabine) 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 (Xeltabine) plus docetaxel combination.
Adjuvant treatment in patients with Dukes' C colon cancer is recommended for a total of 6 months [ie, Capecitabine (Xeltabine) 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)].
In combination with oxaliplatin, the recommended dose of Capecitabine (Xeltabine) is 1000 mg/m² twice daily for 2 weeks followed by a 1-week rest period combined with oxaliplatin at 130 mg/m² intravenous infusion over 2-hours on day 1 every 3 weeks, as 3-week cycles for 24 weeks. Pre-medication, according to the oxaliplatin labeling, should be started with prior to oxaliplatin administration for patients receiving the Capecitabine (Xeltabine) plus oxaliplatin combination.
Gastric cancer: Advanced or colon gastric cancer which is inoperable: The recommended dose of Capecitabine (Xeltabine) 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. Capecitabine (Xeltabine) tablets should be swallowed whole with water within 30 minutes after a meal.
Capecitabine (Xeltabine) is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen: The recommended starting dose of Capecitabine (Xeltabine) is 1000 mg/m² when administered twice daily for 14 days followed by a 7-day rest period, or to 625 mg/m² twice daily when administered continuously. Capecitabine (Xeltabine) tablets should be swallowed whole with water within 30 minutes after a meal. Premedication according to the cisplatin summary of product characteristics should be started prior to cisplatin administration for patients receiving the Capecitabine (Xeltabine) plus cisplatin combination.
In combination with cisplatin, the recommended dose of Capecitabine (Xeltabine) is 1000 mg/m² twice daily for 2 weeks followed by a 1-week rest period, combined with cisplatin at 80 mg/m² as a 2-hour intravenous infusion every 3 weeks.
In combination with cisplatin or epirubicin, the recommended dose of Capecitabine (Xeltabine) is 625 mg/m² twice daily for 3 weeks continuously, combined with cisplatin at 60 mg/m² as a 2-hour intravenous and epirubicin at 50 mg/m² as a intravenous bolus infusion every 3 weeks.
Standard and reduced dose calculations according to body surface area: See Tables 1 and 2.

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Posology adjustments during treatment: Toxicity due to Capecitabine (Xeltabine) administration may be managed by symptomatic treatment and/or modification of the dose (treatment interruption or dose reduction). Once the dose has been reduced, it should not be increased at a later time. For those toxicities considered by the treating physician to be unlikely to become serious or life-threatening, e.g. alopecia, altered taste, nail changes, treatment can be continued at the same dose without reduction or interruption. Patients taking Capecitabine (Xeltabine) should be informed of the need to interrupt treatment immediately if moderate or severe toxicity occurs. (See Table 3.)

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Haematology: 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 (Xeltabine). 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 (Xeltabine) should be interrupted.
Dose modifications for toxicity when Capecitabine (Xeltabine) is used as a 3 weekly cycle in combination with other agents: Dose modifications for toxicity when Capecitabine (Xeltabine) is used as a 3 weekly cycle in combination with other agents should be made according to Table 3 for Capecitabine (Xeltabine) and according to the appropriate summary of product characteristics for the other agent(s).
At the beginning of a treatment cycle, if a treatment delay is indicated for either Capecitabine (Xeltabine) or the other agent(s), then administration of all agents should be delayed until the requirements for restarting all drugs are met.
During a treatment cycle for those toxicities considered by the treating physician not to be related to Capecitabine (Xeltabine), Capecitabine (Xeltabine) should be continued and the dose of the other agent should be adjusted according to the appropriate Prescribing Information.
If the other agent(s) have to be discontinued permanently, Capecitabine (Xeltabine) treatment can be resumed when the requirements for restarting Capecitabine (Xeltabine) are met.
This advice is applicable to all indications and to all special populations.
Dose modifications for toxicity when Capecitabine (Xeltabine) is used continuously in combination with other agents: Dose modifications for toxicity when Capecitabine (Xeltabine) is used continuously in combination with other agents should be made according to Table 3 for Capecitabine (Xeltabine) and according to the appropriate summary of product characteristics for the other agent(s).
Posology adjustments for special populations: Hepatic impairment: Insufficient safety and efficacy data are available in patients with hepatic impairment to provide a dose adjustment recommendation. No information is available on hepatic impairment due to cirrhosis or hepatitis.
Renal impairment: Capecitabine (Xeltabine) is contraindicated in patients with severe renal impairment (creatinine clearance below 30 mL/min at baseline). The incidence of grade 3 or 4 adverse reactions in patients with moderate renal impairment (creatinine clearance 30-50 mL/min at baseline) is increased compared to the overall population. In patients with moderate renal impairment at baseline, a dose reduction to 75% for a starting dose of 1250 mg/m² is recommended. In patients with moderate renal impairment at baseline, no dose reduction is required for a starting dose of 1000 mg/m². In patients with mild renal impairment (creatinine clearance 51-80 mL/min at baseline) no adjustment of the starting dose is recommended. Careful monitoring and prompt treatment interruption is recommended if the patient develops a grade 2, 3 or 4 adverse event during treatment and subsequent dose adjustment as outlined in Capecitabine (Xeltabine) Dose Reduction Schedule. If the calculated creatinine clearance decreases during treatment to a value below 30 mL/min, Capecitabine (Xeltabine) should be discontinued. These dose adjustment recommendations for renal impairment apply both to monotherapy and combination use.
Children under 18: There is no administration experience in patient under 18 years.
Elderly: During Capecitabine (Xeltabine) monotherapy, no adjustment of the starting dose is needed. However, grade 3 or 4 treatment-related adverse reactions were more frequent in patients ≥60 years of age compared to younger patients.
When Capecitabine (Xeltabine) was used in combination with other agents, many elderly patients (≥65 years) experienced more grade 3 and grade 4 adverse drug reactions, including those leading to discontinuation. Careful monitoring of patients ≥60 years of age is advisable.
In combination with docetaxel: An increased incidence of grade 3 or 4 treatment-related adverse reactions and treatment-related serious adverse reactions were observed in patients 60 years of age or more. For patients 60 years of age or more, a starting dose reduction of Capecitabine (Xeltabine) to 75% (950 mg/m² twice daily) is recommended. If no toxicity is observed in patients ≥60 years of age treated with a reduced Capecitabine (Xeltabine) starting dose in combination with docetaxel, the dose of Capecitabine (Xeltabine) may be cautiously escalated to 1250 mg/m² twice daily.