ONCASPAR POWDER FOR SOLUTION FOR INJECTION/INFUSION 750 U/ML [SIN16408P]

Product Info

ONCASPAR POWDER FOR SOLUTION FOR INJECTION/INFUSION 750 U/ML

[SIN16408P]

4.1 Therapeutic indications

Oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (ALL).

4.2 Posology and method of administration

Oncaspar should be prescribed and administered by physicians and/or health care personnel experienced in the use of antineoplastic products. It should only be given in a hospital setting where appropriate resuscitation equipment is available. Patients should be closely monitored for any adverse reactions throughout the administration period (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Posology
Oncaspar is usually administered as part of combination chemotherapy protocols with other antineoplastic agents (see also section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Recommended premedication
Premedicate patients with paracetamol, an H-1 receptor blocker (e.g. diphenhydramine), and an H-2 receptor blocker (e.g. famotidine) 30–60 minutes prior to administration of Oncaspar to decrease the risk and severity of both infusion and hypersensitivity reactions (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 units of pegaspargase (equivalent to 3.3 ml Oncaspar)/m² body surface area every 14 days.

Children with a body surface area <0.6 m² should receive 82.5 units of pegaspargase (equivalent to 0.1 ml Oncaspar)/kg body weight every 14 days.

Adults >21 years
Unless otherwise prescribed, the recommended posology in adults aged >21 years is 2,000 units of pegaspargase (equivalent to 2.67 ml Oncaspar)/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 (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Special populations
Renal impairment
As pegaspargase is a protein with a high molecular weight, it is not excreted renally, and no dose adjustment is necessary in patients with renal impairment.

Hepatic impairment
No dose adjustment is necessary in patients with hepatic impairment.

Elderly
There are limited data available for patients older than 65 years.

Paediatrics
The safety and efficacy of pegaspargase in children <1 year of age are very limited.

Method of administration
Oncaspar can be given by intramuscular (IM) injection or intravenous (IV) infusion.

For smaller volumes, the preferred route of administration is intramuscular. When Oncaspar 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 a higher volume is given, the dose should be divided and given at several injection sites.

Intravenous infusion of Oncaspar 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.

The diluted solution can be given together with an already-running infusion of either sodium chloride 9 mg/ml or 5% glucose. Do not infuse other medicinal products through the same intravenous line during administration of Oncaspar.

For instructions on reconstitution and dilution of this medicinal product before administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Severe hepatic impairment (bilirubin >3 times upper limit of normal [ULN]; transaminases >10 times ULN).
History of serious thrombosis with prior L-asparaginase therapy.
History of pancreatitis, including pancreatitis related to previous L-asparaginase therapy (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
History of serious haemorrhagic events with prior L-asparaginase therapy (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).