Source: Medicines Authority (MT) Revision Year: 2015 Publisher: 1 A Pharma GmbH, Keltenring 1+3, 82041 Oberhaching, Germany
Cytarabine can be used as monotherapy or in combination with other chemotherapeutics in adults and children with:
Cytarabine must only be administered in specialised clinics, by doctors with extensive experience of chemotherapy, and who can offer sufficient opportunities for supportive treatment.
Cytarabine is inactive orally. The dosage and administration method are dependent on the treatment schedule to be followed.
Before commencing chemotherapy, the doctor must be aware of the professional literature in the matter, unwelcome side effects, precautionary measures, contra-indications and warnings in the context of the drugs included in the therapy programme.
Cytarabine can be administered as a single drug or in combination with other cytotoxic drugs, or occasionally corticosteroids.
It is only possible to give general recommendations, as leukaemia is often treated with combinations of cytotoxic drugs, for which a number (2-5) of drugs are used. For the various treatment schedules, refer to the professional literature.
Alexan can be administered both intravenously (by infusion or by injection) and subcutaneously. For preparation of an infusion liquid, Alexan can be added to 0.9% sodium chloride solution and 5% glucose solution.
Rapid intravenous infusion of cytarabine is tolerated better than continuous infusion of the same dose. This is connected to the rapid inactivity of the drug and, as a result of the rapid administration, the short exposure of normal and neoplastic cells to significant levels of the drug.
Conventional doses for remission induction are 100 to 200 mg of cytarabine/m² of body surface daily, in most cases administered as continuous intravenous infusion or rapid infusion for a period of 5 to 10 days.
Duration of treatment depends on clinical and morphological results (bone marrow). The patient may be treated either up to 7 days followed by a therapy free interval of 7-9 days till remission of the bone marrow; afterwards treatment cycles (often restricted) may be continued till remission or occurrence of toxicity or treatment may be continued till occurrence of a bone marrow hypoplasia, which has to be considered as a level of tolerance. Before repeating treatment cycles (often restricted) a therapy free interval of at least 14 days, better till recovery of the bone marrow must be guaranteed.
The dosages for remission maintenance usually are 70 to 200 mg of cytarabine/m² of body surface daily as rapid intravenous injection or as subcutaneous injection daily for five days at a 4-week interval or once weekly.
Suitable polychemotherapy schedules are used for this indication, e.g. the PROMACECYTABOM regimen. The dosage of cytarabine is 300 mg/m² of body surface on day 8 of the respective therapy cycle.
The usage of cytarabine in non-Hodgkin’s lymphomas in children depends on the stage of disease and the histological type. It is applied within different treatment protocols at different dosages, respectively.
The following protocols and dosages are a selection of combination therapies which are considered as effective according to the present scientific knowledge.
Details can be found in the respective medical literature.
150 mg of cytarabine/m² of body surface as one-hour intravenous infusion every 12 hours on days 4 and 5 of the therapy segment denominated “part A” or “part AA” in the protocol (altogether 4 intravenous infusions); in combination with other cytotoxic drugs (BFM protocols for B-cell lymphomas at stage II and III or stage IV).
75 mg of cytarabine/m² of body surface on day 31 to 34, 38 to 41, 45 to 48, and 52 to 55 of induction therapy; in combination with other cytotoxic drugs (BFM protocol for non-B-cell lymphomas at stage I and II).
High-dose therapies are usually carried out with 1 to 3 g of cytarabine/m² of body surface as intravenous infusion during 1 to 3 hours at intervals of 12 hours for 4 to 6 days.
The usual dosage varies from 5 mg to 75 mg per square metre of body surface area.
The administration frequency and dosage varies from regimen to regimen. The most frequently used dosage is 30 mg/m² once every four days, until the cerebrospinal fluid no longer contains an elevated number of malignant cells.
If the solution for injection for intrathecal administration must be diluted, 0.9% sodium chloride without preservative must be used as diluent.
In the event of an overdose, therapy must be stopped, followed by treatment of the subsequent bone marrow depression, including total blood or platelet transfusion and antibiotics, as required.
In the event of intrathecal overdose, the cerebrospinal fluid must immediately be replaced with isotonic salt solution.
Cytarabine can be removed by means of haemodialysis.
3 years.
Storage life after reconstitution:
Chemical and physical stability after dilution with 0.9% (m/f) sodium chloride solution and 5% (m/v) glucose solution has been demonstrated for 4 days at 2-8°C and for 24 hours when stored at a temperature below 25°C.
In the event that reconstitution/ mixture does not take place under aseptic conditions, the storage life of the reconstituted (diluted) product must be limited from a microbiological point of view must be limited to 24 hours at 2-8°C or a maximum of 12 hours at temperatures below 25°C.
Store in the original packaging. Keep the drug out of reach of children.
500mg/10ml (box of 1 vial)
1000mg/20ml (box of 1 vial)
2000mg/40ml (box of 1 vial)
Not all pack sizes may be marketed.
Alexan must be diluted for infusion with 0.9% sodium chloride solution or 5% glucose solution.
Compatibility with 0.9% sodium chloride solution and 5% glucose solution has been studied in concentrations of 0.2-3.2 mg/ml in PVC infusion bags, PE infusion vials and perfusion syringes.
For intrathecal administration, 0.9% sodium chloride without preservative must be used as diluent.
If cytarabine comes into contact with the skin, the exposed area must be rinsed with copious amounts of water, and then washed thoroughly with water and soap. If the solution comes in contact with the eyes, rinse the eyes extremely carefully with copious amounts of water, then contact an eye specialist immediately.
Pregnant employees should be excluded from working with this drug.
After use, bottles and injection materials, including gloves, must be destroyed in accordance with the rules for cytotoxic drugs.
Spilled or leaked product can be inactivated with 5% sodium hypochlorite solution. All cleaning materials must be cleared away as indicated above.
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