Arasid-100/Arasid-500/Arasid-1000 Dosage/Direction for Use

Posology: Treatment with cytarabine should be initiated by, or be in consultation with, a doctor with extensive experience in treatment with cytostatics. Only general recommendations can be given, as acute leukaemia is almost exclusively treated with combinations of cytostatics. Dosage recommendations, may be made accordingly to body weight (mg/kg) or according to BSA (mg/m²). Dosage recommendations may be converted from those in terms of bodyweight to those related to surface area by means of nomograms.
Remission induction: Induction therapy dosage and schedule vary depending on the regimen used.
Continuous treatment: The following dose regimens have been used for continuous treatment on remission induction.
Rapid injection - 2 mg/kg/day is a judicious starting dose. Administer for 10 days. Obtain daily blood counts. If no antileukaemic effect is noted and there is no apparent toxicity, increase to 4 mg/kg/day and maintain until therapeutic response or toxicity is evident. Almost all patients can be carried to toxicity with these doses.
0.5 - 1.0 mg/kg/day may be given in an infusion of up to 24 hours duration. Results from one-hour infusions have been satisfactory in the majority of patients. After 10 days this initial daily dose may be increased to 2 mg/kg/day subject to toxicity. Continue to toxicity or until remission occurs.
Intermittent treatment: The following dose regimen have been used for intermittent treatment in remission induction.
3-5 mg/kg/day are administered intravenously on each of five consecutive days. After a two to nine-day rest period, a further course is given. Continue until response or toxicity occurs.
The first evidence of marrow improvement has been reported to occur 7 - 64 days (mean 28 days) after the beginning of therapy.
In general, if a patient shows neither toxicity nor remission after a fair trial, the cautious administration of higher doses is warranted. As a rule, patients have been seen to tolerate higher doses when given by rapid intravenous injection as compared with slow infusion. This difference is due to the rapid metabolism of Cytarabine and the consequent short duration of action of the high dose.
Cytarabine 100-200 mg/m²/24 hours, as continuous infusion for 5-7 days alone or in combination with other cytostatics including for instance an anthracycline has been used. Additional cycles may be administered at intervals of 2-4 weeks, until remission is achieved or unacceptable toxicity occurs.
Maintenance therapy: Maintenance dosage and schedule vary depending on the regimen used.
The following dose regimens have been used for continuous treatment following remission induction.
Remissions, which have been induced by Cytarabine, or by other drugs, may be maintained by intravenous or subcutaneous injection of 1 mg/kg once or twice weekly.
Cytarabine 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.
High dosage: Cytarabine, 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). A total treatment dose of 36 g/m² should not be exceeded. Frequently of treatment cycles depends on the response to treatment and hematological and non-hematological toxicity. Also refer to precautions for treatment stopping requirements.
Paediatric patients: Safety in infants has been not established.
Patient with hepatic and renal impairment: Patient with impaired hepatic or renal function: Dosage should be reduced.
Cytarabine can be dialyzed. Therefore, Cytarabine should not be administered immediately before or after a dialysis.
Elderly Patients: High dose therapy in patient >60 years should be administered only after careful risk benefit evaluation.
Method of administration: For instructions on dilution of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage. Cytarabine injection is intended for intravenous infusion or injection, or subcutaneous injection.
Subcutaneous injection is generally well tolerated, and may be recommended when used in maintenance therapy. Cytarabine 100 mg/ml should not be administered by the intrathecal route.