ONCASPAR Solution for injection/infusion Ref.[9116] Active ingredients: Pegaspargase

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 and carefully observed for any adverse reactions throughout the administration period (see section 4.4).

Posology

Oncaspar is usually administered as part of combination chemotherapy protocols with other antineoplastic agents (see also section 4.5).

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 Oncaspar)/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 Oncaspar)/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 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).

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.

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 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.

Cases of accidental overdose have been reported with Oncaspar. Following overdose, increased liver enzymes, rash and hyperbilirubinaemia have been observed. There is no specific pharmacological treatment for the overdose. In case of overdose, patients must be carefully monitored for signs and symptoms of adverse reactions, and appropriately managed with symptomatic and supportive treatment.

Shelf life: 8 months.

Chemical and physical in-use stability of the diluted solution has been demonstrated for 48 hours at 2°C-8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C-8°C, unless dilution has taken place in controlled and validated aseptic conditions.

Store in a refrigerator (2°C–8°C).

Do not freeze.

5 ml solution in a vial (type I glass) with stopper (rubber) and a seal (aluminium) with flip-off cap.

Pack size of 1.

This medicinal product can cause irritation on contact. The solution must therefore be handled and administered with particular caution. Inhalation of the vapour and contact with the skin and mucous membranes, especially the eyes, must be avoided. In case of contact, irrigate with plenty of water for at least 15 minutes.

The solution can be diluted with 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for injection before intravenous injection (see section 4.2).

Do not use if the solution is cloudy or a precipitate has formed. Do not shake.

Oncaspar is for single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.