Patients with hepatic and renal impairment: Paediatric patients : Children appear to tolerate higher doses than adults and, where dose ranges are quoted, the children should receive the higher dose and the adults the lower. Also refer to precautions (4.4) for treatment stopping requirements. Frequency of treatment cycles depends on the response to treatment and hematological and non-hematogological toxicity. A total treatment dose of 36 g/m 2should not be exceeded. See section 4.8.Ĭytarabine, under strict medical surveillance, is administered as monotherapy or in combination with other cytostatics, 2-3 g/m², as intravenous infusion, for 1-3 hours every 12 hours for 2-6 days (total of 12 doses per cycle). Maintainance therapy: To maintain remission, doses of 1 mg/kg may be given intravenously or subcutaneously, once or twice weekly.Ĭytarabine has also been administered in doses of 100-200 mg/m², as continuous infusion for 5 days at monthly intervals as monotherapy or in combination with other cytostatics.ĭoses between 5 and 30 mg/m² BSA have been administered.įor the treatment of meningeal leukemia, usually a dose of 30 mg/m² BSA is given once every 4 days until cerebrospinal fluid findings are normal, followed by one additional dose. Additional cycles may be administered at intervals of 2-4 weeks, until remission is achieved or unacceptable toxicity occurs. This difference is due to the rapid metabolism of Cytarabine and the consequent short duration of action of the high dose.Ĭytarabine has been given in doses of 100-200 mg/m 2/24 hours by continuous infusion for 5-7 days alone or combination with other cytostatics including for instance an anthracycline has been used. Generally patients tolerate higher doses given by rapid intravenous injection rather than slow infusion. In general, if a patient shows neither remission nor toxicity after a trial period, the cautious administration of higher doses is warranted. This course of treatment can be repeated after 2 to 9 days rest period, and repeated until the therapeutic response or toxicity is exhibited.Įvidence of bone marrow improvement has been reported to occur 7-64 days (mean 28 days) after the beginning of therapy. Intermittent treatment: Cytarabine may be given as intermittent intravenous doses of 3-5 mg/kg daily, for five consecutive days. Results from one hour infusions have been satisfactory in the majority of patients. Continue to toxicity or until remission occurs. Almost all patients can be carried to toxicity with these doses.Ġ.5 to 1 mg/kg/day may be infused daily in 1-24 hours for ten days, and then at a rate of 2 mg/kg/day until toxicity is observed. If after ten days neither therapeutic response nor toxicity has been observed, the dose may be increased to 4 mg/kg/day until a therapeutic response or toxicity is evident. Dose recommendation may be converted from those in terms of bodyweight to those related to surface area by means of nomograms.Ĭontinuous treatment: The usual dose in leukaemia is 2 mg/kg/day by rapid intravenous injection daily for ten days. Only general recommendations can be given, as acute leukaemia is almost exclusively treated with combinations of cytostatics.ĭosage recommendations, may be made according to body weight (mg/kg) or according to BSA(mg/m 2). Treatment with cytarabine should be initiated by, or be in consultation with, a doctor with extensive experience in treatment with cytostatics. Subcutaneous injection is generally well tolerated, and may be recommended when used in maintenance therapy.Ĭytarabine 20 mg/ml solution for injection/infusion can be diluted with Sterilised Water for Injections, Glucose Intravenous Infusion or Sodium Chloride Intravenous Infusion. Date of first authorisation/renewal of the authorisationĬytarabine 20 mg/ml solution for injection/infusion is intended for intravenous, intramuscular, subcutaneous or intrathecal use. 6.6 Special precautions for disposal and other handling.
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