Active Ingredient: Pegaspargase
Pegaspargase is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years, and adult patients.
For this indication, competent medicine agencies globally authorize below treatments:
Intramuscular
82.5 - 82.5 [iU] per kg of body weight
From 82.5 To 82.5 [iU] per kg of body weight once every 14 day(s)
Pegaspargase is usually administered as part of combination chemotherapy protocols with other antineoplastic agents.
The recommended dose in patients with a body surface area (BSA) ≥0.6 m² and who are ≤21 years of age is 2,500 U of pegaspargase (equivalent to 3.3 ml pegaspargase)/m² body surface area every 14 days.
Children with a body surface area <0.6 m² should receive 82.5 U of pegaspargase (equivalent to 0.1 ml pegaspargase)/kg body weight every 14 days.
Treatment may be monitored based on the trough serum asparaginase activity measured before the next administration of pegaspargase. If asparaginase activity values fail to reach target levels, a switch to a different asparaginase preparation could be considered.
Pegaspargase can be given by intramuscular (IM) injection or intravenous (IV) infusion.
For smaller volumes, the preferred route of administration is intramuscular. When pegaspargase is given by intramuscular injection the volume injected at one site should not exceed 2 ml in children and adolescents and 3 ml in adults. If higher volume is given, the dose should be divided and given at several injection sites.
Intravenous
82.5 - 82.5 [iU] per kg of body weight
From 82.5 To 82.5 [iU] per kg of body weight once every 14 day(s)
Pegaspargase is usually administered as part of combination chemotherapy protocols with other antineoplastic agents.
The recommended dose in patients with a body surface area (BSA) ≥0.6 m² and who are ≤21 years of age is 2,500 U of pegaspargase (equivalent to 3.3 ml pegaspargase)/m² body surface area every 14 days.
Children with a body surface area <0.6 m² should receive 82.5 U of pegaspargase (equivalent to 0.1 ml pegaspargase)/kg body weight every 14 days.
Treatment may be monitored based on the trough serum asparaginase activity measured before the next administration of pegaspargase. If asparaginase activity values fail to reach target levels, a switch to a different asparaginase preparation could be considered.
Pegaspargase can be given by intramuscular (IM) injection or intravenous (IV) infusion.
Intravenous infusion of pegaspargase is usually given over a period of 1 to 2 hours in 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection or 5% glucose solution.
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