CYTARABINE Solution for injection Ref.[7212] Active ingredients: Cytarabine

Posology

Cytarabine 20 mg/ml Injection can be diluted with Sterilised Water for Injections BP, Glucose Intravenous Infusion BP or Sodium Chloride Intravenous Infusion BP. Prepared infusions, in the recommended diluents should be used immediately. Alternatively, the diluted infusion fluids may be stored at 2-8°C, protected from light, but portions remaining unused after 24 hours must be discarded.

Remission Induction: Adults

Continuous Dosing

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.

Leukaemic Meningitis

Therapy for established meningitis employs a wide variety of dose regimens but a recommended total daily dose not exceeding 100 mg, alternating with methotrexate (given either systemically or intrathecally) is recommended. Cytarabine has been given intrathecally at doses of 10-30 mg/m² three times a week until cerebro-spinal fluid findings return to normal.

Myelosuppression, anaemia and thrombocytopenia occur almost to all patients given daily infusions or injections. Myelosuppression is biphasic and nadirs at 7-9 and 15-24 days. Evidence of bone marrow improvement may be expected 7-64 (mean 28) days after the beginning of treatment.

Paediatric population

Children appear to tolerate higher doses of cytarabine than adults, and where the range of doses is given, children should receive the higher dose.

Elderly

No data is available to suggest that a change in dose is necessary in the elderly. However, the elderly patient is more susceptable to toxic reactions and therefore particular attention should be paid to drug induced leucopenia, thrombocytopenia and anaemia.

Method of administration

Cytarabine 20 mg/ml Injection is a ready to use solution and is suitable for intravenous, subcutaneous and intrathecal use.

There is no specific antidote for cytarabine overdose. Cessation of therapy followed by management of ensuing bone marrow depression including whole blood or platelet transfusion and antibiotics as required. Twelve doses of 4.5 g/m² by IV infusion over one hour every 12 hours induces irreversible and fatal central nervous system toxicity.

Cytarabine may be removed by haemodialysis.

Shelf life

Before use: 18 Months.

In use: Chemical and physical in-use stability has been demonstrated for 7 days at room temperature.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.

Do not store above 25°C. Keep container in the outer carton, in order to protect from light.

Clear Type I glass vials, rubber stopper.

Clear Type I Onco-Tain Vials, rubber stopper.

Pack sizes 5’s, 25’s and 50’s.

Not all presentations and pack sizes may be marketed.

Use in the paediatric population

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.