Sancitabin Dosage/Direction for Use

SANCITABIN should only be prescribed by qualified physician experienced in the utilization of antineoplastic agents. SANCITABIN tablets should be swallowed with water within 30 minutes after a meal. Treatment should be discontinued if progressive disease or intolerable toxicity is observed. Standard and reduced dose calculations according to body surface area for starting doses of SANCITABIN of 1250 mg/m² and 1000 mg/m² are provided in Tables 1 and 2, respectively.
Monotherapy: Colon and Colorectal Cancer: The recommended dose of SANCITABIN in the adjuvant treatment of colon cancer or in the treatment of metastatic colorectal cancer is 1250 mg/m² administered twice daily (morning and evening; equivalent to 2500 mg/m² total daily dose) for 14 days followed by a 7-day rest period.
Adjuvant treatment in patients with stage III colon cancer is recommended for a total of 6 months, SANCITABIN 1250 mg/m² administered twice daily for 14 days followed by a 7-day rest period, given as 3-week cycles for a total of 8 cycles (24 weeks).
Breast Cancer: Given as a monotherapy, the recommended dose of SANCITABIN in the treatment of locally advanced or metastatic breast cancer is 1250 mg/m² twice daily for 14 days followed by a 7-day rest period.
Combination Therapy: Breast Cancer: In combination with Docetaxel, the recommended dose of SANCITABIN in the treatment of metastatic breast cancer is 1250 mg/m² twice daily for 14 days followed by a 7-day rest period, combined with Docetaxel at 75 mg/m² as a 1 hour intravenous infusion every 3 weeks. Premedication with an oral corticosteroid such as Dexamethasone according to the Docetaxel summary of product characteristics should be started prior to Docetaxel administration for patients receiving the SANCITABIN plus Docetaxel combination.
Advanced Gastric Cancer: In combination with a platinum-based compound the recommended dose of SANCITABIN for the treatment of advanced gastric cancer is 1000 mg/m² administered twice daily for 14 days followed by a 7-day rest period. The first dose of SANCITABIN should be given on the evening of day 1 and the last dose should be given on the morning of day 15.
Premedication to maintain adequate hydration and anti-emesis according to the Cisplatin summary of product characteristics should be started prior to Cisplatin administration for patients receiving the SANCITABIN plus Cisplatin combination. (See Tables 1 and 2.)


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Patients with Renal Impairment: SANCITABIN is contraindicated in patients with severe renal impairment (creatinine clearance below 30 mL/min). In patients with moderate renal impairment (creatinine clearance 30-50 mL/min) at baseline, a dose reduction to 75% for a starting dose of 1250 mg/m² is recommended and no required dose reduction for a starting dose of 1000 mg/m². In patents with mild renal impairment (creatinine clearance 51-80 mL/min) no recommended adjustment of the starting dose. These dose adjustment recommendations for renal impairment apply both to monotherapy and combination use.
Children: There is no experience in children (under 18 years).
Elderly Patients: For SANCITABIN monotherapy, no needed adjustment of the starting doses. Careful monitoring of patients ≥60 years of age is advisable.
For patients 60 years of age or more treated with the combination of SANCITABIN plus Docetaxel, a starting dose reduction of SANCITABIN to 75% (950 mg/m² twice daily) is recommended. If no toxicity is observed in patients ≥60 years of age treated with a reduced SANCITABIN starting dose in combination with Docetaxel, the dose of SANCITABIN may be cautiously escalated to 1250 mg/m² twice daily.
Toxicity: Toxicity due to SANCITABIN administration may be managed by symptomatic treatment and/or modification of the SANCITABIN dose (treatment interruption or dose reduction). Once the dose has been reduced it should not be increased at a later time. Patients taking SANCITABIN should be informed of the need to interrupt treatment immediately if moderate or worse toxicity occurs. Doses of SANCITABIN omitted for toxicity are not replaced or restored, instead the patient should resume the planned treatment cycle. The following are recommended dose modifications: (See Table 3.)


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Dose modifications for toxicity when SANCITABIN is used as a 3 weekly cycle in combination with other agents: SANCITABIN should be used according to Table 3 as previously mentioned and according to the appropriate of product characteristics for the other agent.
At the beginning of a treatment cycle, if a treatment delay is indicated for either SANCITABIN or the other agent, then administration of both agents should be delayed until requirement for restarting both drugs are met.
During treatment cycle for those toxicities considered by the treating physician not to be related SANCITABIN (for example, neurotoxicity or ototoxicity), then SANCITABIN should be continued and the other agent should be discontinued according to the appropriate Prescribing Information.
If the other agent(s) have to be discontinued permanently, SANCITABIN treatment can be resumed when the requirements for restarting SANCITABIN are met. This advice is applicable to all indications and to all special populations.
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.
Dose modification for toxicity when SANCITABIN is used continuously in combination with other agents: SANCITABIN should be used according to Table 3 as previously mentioned and according to the appropriate of product characteristics for the other agent.
Haematology: SANCITABIN treatment may continue throughout a grade 3 neutropenic episode. However, the patient should be closely monitored and administration of SANCITABIN should be interrupted if any grade 2 clinical event (e.g. diarrhoea, stomatitis, fever) coincides with the grade 3 neutropenic episode. If grade 4 neutropenia occurs treatment with SANCITABIN should be interrupted until recovery to grade 0-1. Treatment should only be readministered when the neutrophil count is ≥1.5x10⁹/L (grade 0-1).
Patients with baseline neutrophil counts of ≤1.5x10⁹/L and/or thrombocyte counts of <100x10⁹/L should not be treated with SANCITABIN.
If the neutrophil count drops below 1.0x10⁹/L or if the platelet count drops below 75x10⁹/L, stop SANCITABIN. At recovery, restart SANCITABIN at full dose.
Dehydration: Dehydration should be prevented or corrected at the onset. Patients with anorexia, asthenia, nausea, vomiting or diarrhoea may rapidly become dehydrated. If Grade 2 (or higher) dehydration occurs, SANCITABIN treatment should be immediately interrupted and the dehydration corrected. Treatment should not be restarted until the patient is rehydrated and any precipitating causes have been corrected or controlled. Dose modifications applied should be those for the precipitating adverse event in accordance with the previously mentioned guidelines.