Source: Health Products and Food Branch (CA) Revision Year: 2019
KIDROLASE (L-asparaginase) is indicated mainly to induce remissions in acute lymphoblastic leukemia. Remissions have also been obtained in cases of acute myeloblastic and acute myelomonocytic leukemia although these forms are less sensitive to the action of the enzyme. Favourable results have sometimes been obtained with L-asparaginase in certain cases of lymphosarcoma, reticulosarcoma, Hodgkin’s disease, chronic lymphocytic leukemia and melanosarcoma.
The treatment with KIDROLASE (L-asparaginase) should be initiated and continuously supervised by experienced physicians qualified in cancer chemotherapy.
Daily administration is the most usual method and the least likely to cause side effects. The dosage varies from 200 to 1,000 I.U. per kg per day for 28 consecutive days. After this period, if complete remission is obtained, maintenance therapy is instituted, otherwise induction treatment is continued for another 14 days.
KIDROLASE may also be administered intermittently with 3 injections per week for 4 weeks using the following dosage schedule:
After this period, maintenance therapy is instituted if complete remission is obtained; otherwise, the treatment is continued for another 14 days.
When intermittent administration has been used, anaphylactic reactions with L-asparaginase were 3 times more frequent when administered I.V. than when injected I.M. Consequently, the I.M. route is recommended for intermittent administration.
When L-asparaginase is used in association with other antileukemic drugs, full doses, as stated above, should be administered.
The choice of dose and method of administration is made according to the particular circumstances governing each case.
Administer KIDROLASE either intramuscularly, or intravenously into the tubing of a running infusion of an isotonic glucose solution or of normal saline which does not contain a preservative.
| Vial Size | Volume of Diluent to be Added to Vial | Approximate Available Volume | Nominal Concentration per mL |
|---|---|---|---|
| 7 mL capacity vial, containing 10,000 IU Lasparaginase as powder for reconstitution | 4mL of Water for Injection | 4 mL | When reconstituted with 4 mL the resultant concentration is 2,500 IU per mL. |
Reconstitution and dilution should be carried out in controlled and validated aseptic conditions.
Reconstitute by adding Water for Injection into the vial of L-Asparaginase. Slowly add the Water for Injection against the inner vial wall, do not squirt directly onto or into the powder. Gently swirl or rotate the vial until the powder is dissolved. Do not shake the vial to prevent foam forming. The solution is to be inspected visually for particulate matter and discolouration prior to administration. The solution should only be used if the solution is clear and free from particles.
Calculate the required volume of the reconstituted solution needed to obtain the appropriate dose. Withdraw this amount from the vial using a syringe. Transfer the required amount of the reconstituted solution to an infusion container with either sodium chloride (0.9%) or glucose solution (5%). Discard any unused reconstituted solution left in the vial. Gently invert the infusion container to mix the diluted solution. Do not shake.
The solution is to be inspected visually for particulate matter and discolouration prior to administration. The solution should only be used if the solution is clear and free from particles. The diluted solution ranges in colour from clear light yellow to brown.
If a dose is missed or the product had to be temporarily discontinued, dosing should be continued as soon as possible, taking into account the importance of continued asparagine depletion.
Two cases of accidental overdosage were reported where children received an injection representing 10 times the normal daily dose. No clinical signs were observed but, in one case, there was an increase in aspartic and glutamic acid plasma levels.
There is no known antidote for asparaginase overdoses. No data are available on the elimination (peritoneal or by haemodialysis) of the product. Patients who accidentally receive an overdose of L-asparaginase should be monitored closely and receive any appropriate symptomatic and supportive treatment.
For management of a suspected drug overdose, contact your regional Poison Control Centre.
Unopened product in powder form: Is stable for up to 24 months at 2°C to 8°C.
Reconstituted product: When not refrigerated should be used immediately (within 3 hours). If not and storage is required, keep refrigerated (2°C to 8°C) and use within 72 hours.
Diluted product: The diluted product for IV infusion should be used immediately. If this is unavoidable the solution should be stored at a temperature between 2°C and 8°C, and used within 72 hours when diluted with Sodium Chloride 0.9% or 24 hours when diluted with a glucose solution (5%).
KIDROLASE (L-asparaginase) contains no preservative. Reconstitution and dilution should be done under strict aseptic conditions.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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