Acute lymphoblastic leukaemia (ALL)

Indication for Pegaspargase

Population group: Suitable for both men and women, only adults (18 - 65 years old)

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:

2000-2500 IU once every 2 weeks

Route of admnistration

Intramuscular

Defined daily dose

2,000 - 2,500 [iU]

Dosage regimen

From 2,000 To 2,500 [iU] once every 14 day(s)

Detailed description

Pegaspargase is usually administered as part of combination chemotherapy protocols with other antineoplastic agents.

Paediatric patients and adults ≤21 years

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.

Adults >21 years

Unless otherwise prescribed, the recommended posology in adults aged >21 years is 2,000 U of pegaspargase (equivalent to 2.67 ml pegaspargase)/m² body surface area 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.

Dosage considerations

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.

2000-2500 IU once every 2 weeks

Route of admnistration

Intravenous

Defined daily dose

2,000 - 2,500 [iU]

Dosage regimen

From 2,000 To 2,500 [iU] once every 14 day(s)

Detailed description

Pegaspargase is usually administered as part of combination chemotherapy protocols with other antineoplastic agents.

Paediatric patients and adults ≤21 years

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.

Adults >21 years

Unless otherwise prescribed, the recommended posology in adults aged >21 years is 2,000 U of pegaspargase (equivalent to 2.67 ml pegaspargase)/m² body surface area 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.

Dosage considerations

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.

Active ingredient

Pegaspargase is a covalent conjugate of Escherichia coli-derived L-asparaginase with monomethoxypolyethylene glycol. The mechanism of action of L-asparaginase is the enzymatic cleavage of the amino acid L-asparagine into aspartic acid and ammonia. Depletion of L-asparagine in blood results in inhibition of protein-synthesis, DNA-synthesis and RNA-synthesis, especially in leukaemic blasts which are not able to synthesise L-asparagine, thus undergoing apoptosis.

Read more about Pegaspargase

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