SPECTRILA Powder for concentrate for solution for infusion Ref.[6229] Active ingredients: Asparaginase

Spectrila should be prescribed and administered by physicians and 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.

Posology

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

Adults and children older than 1 year

The recommended intravenous dose of asparaginase is 5,000 units per square metre (U/m²) body surface area (BSA) given every third day.

Treatment may be monitored based on the trough serum asparaginase activity measured three days after administration of Spectrila. If asparaginase activity values fail to reach target levels, a switch to a different asparaginase preparation could be considered (see section 4.4).

Data on efficacy and safety of Spectrila in adults are limited.

Data on efficacy and safety of Spectrila in the post-induction treatment phases are very limited.

Special populations

Renal impairment

No dose adjustment is necessary in patients with renal impairment.

Hepatic impairment

No dose adjustment is necessary in patients with mild to moderate hepatic impairment. However, Spectrila should not be used in patients with severe hepatic impairment (see section 4.3).

Elderly

Limited data are available for the treatment of patients older than 65 years of age.

Children 0–12 months old

Based on limited data, the recommended dose in infants is as follows:

• age less than 6 months: 6,700 U/m² BSA,
• age 6–12 months: 7,500 U/m² BSA.

Method of administration

Spectrila is for administration by intravenous infusion only.

The daily amount of Spectrila needed per patient can be diluted in a final volume of 50-250 ml sodium chloride 9 mg/ml (0.9%) solution for infusion. The diluted solution of asparaginase may be infused over 0.5 to 2 hours.

Asparaginase must not be administered as a bolus dose.

No case of asparaginase overdose with clinical symptoms has been reported. There is no specific antidote. Treatment is symptomatic and supportive.

Unopened vials:

4 years.

Reconstituted and diluted solution:

Chemical and physical in-use stability has been demonstrated for 2 days 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 reconstitution/dilution has taken place in controlled and validated aseptic conditions.

Store in a refrigerator (2°C–8°C).

Keep the vial in the outer carton in order to protect from light.

For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.

Colourless 20 ml glass vial (Type I glass) closed with butylrubber stopper, aluminium seal and plastic flip-off cap, containing 10,000 units of asparaginase.

Each pack contains either 1 or 5 vials. Not all pack sizes may be marketed.

To dissolve the powder, 3.7 ml of water for injections are carefully squirted against the inner wall of the vial with an injection syringe (do not squirt directly on or into the powder). Dissolution of the contents is achieved by slow turning (avoid froth formation due to shaking). The reconstituted solution may exhibit a slight opalescence.

The calculated quantity of asparaginase is dissolved further in 50 to 250 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.