Acute myeloid leukaemia, acute non-lymphoblastic leukaemia, acute lymphoblastic leukaemia, acute lymphocytic leukaemia

Indication for Cytarabine

Population group: Suitable for both men and women, only children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 years old or older)

Cytarabine may be used alone or in combination with other antineoplastic agents. It is indicated alone or in combination for induction of remission and/or maintainance in patients with acute myeloid leukaemia, acute non-lymphoblastic leukaemias, acute lymphoblastic leukaemias, acute lymphocytic leukaemia, and blast crises of chronic myeloid leukaemia. Clinicians should refer to the current literature on combination therapy before initiating treatment.

For this indication, competent medicine agencies globally authorize below treatments:

1-4 mg/kg once daily

Route of admnistration


Defined daily dose

1 - 4 mg per kg of body weight

Dosage regimen

From 1 To 4 mg per kg of body weight once every day

Detailed description

The usual dose in leukaemia, is 2 mg/kg by rapid intravenous injection daily for ten days. If after ten days neither therapeutic response not toxicity has been observed, the dose may be increased to 4 mg/kg until a therapeutic response or toxicity is evident. Daily blood counts should be taken. Almost all patients can be carried to toxicity with these doses.

Alternatively, 0.5 to 1 mg/kg 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. Continue to toxicity or until remission occurs. Results from one hour infusions have been satisfactory in the majority of patients.

Intermittent dosing

Cytarabine may be given as intermittent intravenous doses of 3-5 mg/kg daily, for five consecutive days This course of treatment can be repeated after an interval of 2 to 9 days, and repeated until the therapeutic response or toxicity is exhibited.

Evidence of bone marrow inprovement has been reported to occur 7-64 days days after the beginning of therapy.

In general, if a patient shows neither remission or toxicity after a trial period, then cautiously administered higher doses can be administered. Generally patients tolerate higher doses given by rapid intravenous injection rather than slow infusion.

As a single agent for induction of remissions in patients with acute leukaemia, cytarabine has been given in doses of 200 mg/m² by continuous intravenous infusion for five days at approximately 2 week intervals.

Maintainance therapy

To maintain remission, doses of 1 mg/kg may be given intravenously or subcutaneously, once or twice weekly.

Active ingredient

Cytarabine (ARA-C) is metabolised in vivo to ARA-CTP phosphorylated compound. This competitively inhibits DNA polymerase and may also inhibit certain acid kinase enzymes.

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