Cytarabine Injection Solution 100 mg/ml
Hospira UK Ltd
1. Name of the medicinal product
Cytarabine 100 mg/ml Injection
2. Qualitative and quantitative composition
Each 1 ml contains 100 mg of cytarabine
Presentations
100 mg/1 ml
500 mg/5 ml
1 g/10 ml
2 g/20 ml
Amount cytarabine Present
100 mg
500 mg
1 g
2 g
For the full list of excipients see 6.1
3. Pharmaceutical form
Solution for injection.
Clear, colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
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 maintenance in patients with acute myeloid leukaemia, acute non-lymphoblastic leukaemias, acute lymphoblastic leukaemias, acute lymphocytic leukaemia, erythroleukaemia, blast crises of chronic myeloid leukaemia, diffuse histiocytic lymphomas (non-Hodgkin's lymphomas of high malignancy), meningeal leukaemia and meningeal neoplasms. Clinicians should refer to the current literature on combination therapy before initiating treatment.
4.2 Posology and method of administration
Posology
Cytarabine Injection can be diluted with Sterile 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 nor 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 improvement has been reported to occur 7-64 days after the beginning of therapy.
In general, if a patient shows neither remission nor 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.
Maintenance therapy: To maintain remission, doses of 1 mg/kg may be given intravenously or subcutaneously, once or twice weekly.
Leukemic 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 is recommended.
Myelosuppression, anaemia and thrombocytopenia occur almost to all patients given daily inf |
