Active Ingredient: Asparaginase
Asparaginase is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of lymphoblastic lymphoma (LBL) in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A, in case that patient age in months is ≥ 1
Intramuscular, 25 milligrams asparaginase per square meter of body surface, once every 48 hours.
Regimen B, in case that patient age in months is ≥ 1
Intravenous, 25 milligrams asparaginase per square meter of body surface, once every 48 hours.
Regimen C, in case that patient age in months is ≥ 1
Intramuscular, 25 milligrams asparaginase per square meter of body surface, one dose, over the duration of 2 days. Afterwards, intramuscular, 25 milligrams asparaginase per square meter of body surface, one dose, over the duration of 2 days. Afterwards, intramuscular, 50 milligrams asparaginase per square meter of body surface, one dose, over the duration of 3 days.
Regimen D, in case that patient age in months is ≥ 1
Intravenous, 25 milligrams asparaginase per square meter of body surface, one dose, over the duration of 2 days. Afterwards, intravenous, 25 milligrams asparaginase per square meter of body surface, one dose, over the duration of 2 days. Afterwards, intramuscular, 50 milligrams asparaginase per square meter of body surface, one dose, over the duration of 3 days.
Regimen E, in case that patient age in months is ≥ 1
Intravenous, 25 milligrams asparaginase per square meter of body surface, one dose, over the duration of 2 days. Afterwards, intravenous, 25 milligrams asparaginase per square meter of body surface, one dose, over the duration of 2 days. Afterwards, intravenous, 50 milligrams asparaginase per square meter of body surface, one dose, over the duration of 3 days.
The recommended dose of asparaginase is:
Or
A consideration to premedicate patients with paracetamol, an H1 receptor blocker, and an H2 receptor blocker 30–60 minutes prior to administration should be made when asparaginase is being given intravenously to decrease the risk and severity of infusion related reaction/hypersensitivity reaction.
Asparaginase activity can vary between individuals, therefore trough SAA should be monitored. When administered every 48 hours a trough asparaginase activity measurement should be performed at 48 hours post dose. When dosing on a Monday/Wednesday/Friday schedule, trough SAA should be measured 72 hours after the Friday dose and prior to administration of the following Monday dose. The dosing schedule or route of administration should then be individually adapted.
Therapy can be further adjusted according to local treatment protocols.
Asparaginase is for intramuscular and/or intravenous use.
For intramuscular use, limit the volume of asparaginase at a single injection site to 2 mL for patients with a body surface area (BSA) >0.5 m², for patients with a BSA <0.5 m² limit the volume to 1 mL. If the volume to be administered is greater than the mentioned limits, use multiple injection sites.
For intravenous infusion, it is recommended to administer the dose over 2 hours.
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