Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Jazz Pharmaceuticals Ireland Ltd, 5th Floor, Waterloo Exchange, Waterloo Road, Dublin 4, D04 E5W7, Ireland
Enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL) in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase.
Enrylaze should be prescribed and administered by physicians and healthcare personnel experienced in the use of antineoplastic products. Appropriate resuscitation equipment and other agents necessary to treat anaphylaxis should be available when administering Enrylaze.
The recommended dose of Enrylaze is:
Or
A consideration to premedicate patients with paracetamol, an H1 receptor blocker, and an H2 receptor blocker 30–60 minutes prior to administration should be made when Enrylaze is being given intravenously to decrease the risk and severity of infusion related reaction/hypersensitivity reaction.
Asparaginase activity can vary between individuals, therefore trough SAA should be monitored. When administered every 48 hours a trough asparaginase activity measurement should be performed at 48 hours post dose. When dosing on a Monday/Wednesday/Friday schedule, trough SAA should be measured 72 hours after the Friday dose and prior to administration of the following Monday dose. The dosing schedule or route of administration should then be individually adapted (see section 4.4).
Therapy can be further adjusted according to local treatment protocols.
The dose of Enrylaze is administered in mg/m² and is not administered in units/m², as used for other asparaginase preparations. Enrylaze is not interchangeable with other crisantaspase products to complete a cycle of treatment.
Dose adjustment is not required for patients that develop total bilirubin ≤3 times the Upper Limit of Normal (ULN) during treatment.
Enrylaze should be withheld if total bilirubin is >3 times to ≤10 times the ULN during treatment, treatment can continue once resolved. In the event of a severe occurrence (total bilirubin >10 times the ULN), treatment should be stopped and patients not rechallenged (see section 4.4).
Dose adjustment is not required for patients with pre-existing mild or moderate hepatic impairment (total bilirubin >1 to 3 times the ULN or AST greater than the ULN). There are insufficient data in patients with pre-existing severe hepatic impairment to support a dose recommendation.
There are insufficient data in patients with mild, moderate or severe renal impairment to support a dose recommendation.
No dose adjustment is required in paediatric patients. The safety and efficacy of children aged younger than 1 month has not yet been established.
No dose adjustment is required in elderly patients.
Enrylaze is for intramuscular and/or intravenous use.
For intramuscular use, limit the volume of Enrylaze at a single injection site to 2 mL for patients with a body surface area (BSA) >0.5 m², for patients with a BSA <0.5 m² limit the volume to 1 mL. If the volume to be administered is greater than the mentioned limits, use multiple injection sites.
For intravenous infusion, it is recommended to administer the dose over 2 hours.
For instructions on dilution of the medicinal product before intravenous administration, see section 6.6.
No case of Enrylaze overdose with clinical symptoms has been reported and there is no specific antidote. Treatment is symptomatic and supportive.
3 years.
From a microbiological point of view, unless the method of opening/dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
Intramuscular preparation: Chemical and physical in-use stability for intramuscular preparations in a polypropylene syringe has been demonstrated for up to 8 hours at room temperature (15°C–25°C) or 24 hours when refrigerated (2°C–8°C).
Intravenous preparation: Chemical and physical in-use stability for intravenous preparations has been demonstrated for up to 12 hours at room temperature (15°C–25°C) or 24 hours when refrigerated (2°C–8°C). The storage times start from withdrawing the required volume from the unopened vials. The storage time in the polyethylene inner lined intravenous bag includes the 2-hour administration time (see section 6.6).
Store in a refrigerator (2°C–8°C) in an upright position.
Keep the vial in the outer carton in order to protect from light.
Do not freeze.
For storage conditions after dilution of the medicinal product, see section 6.3.
2 mL Type 1 clear borosilicate glass vial sealed with a halobutyl rubber stopper and aluminium overseal and a violet plastic cap.
Pack size: 3 vials.
Compatibility has been demonstrated in the following materials. No other materials have been studied.
Subsequent steps for intravenous infusion preparation:
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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