ENRYLAZE

What it is

Enrylaze is recombinant crisantaspase (L-asparaginase from *Erwinia chrysanthemi*) produced by recombinant DNA technology in *Pseudomonas fluorescens*. It is supplied as a solution for injection/infusion. Each vial of 0.5 mL solution contains 10 mg of crisantaspase.

Approved indications

— Treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adults and paediatric patients (1 month and older) who have developed hypersensitivity or silent inactivation to *E. coli*-derived asparaginase, as a component of a multi-agent chemotherapeutic regimen.

Dosing overview

Enrylaze is dosed in mg/m² and not in units/m² as used for other asparaginase preparations. The recommended dosage follows either a Monday/Wednesday/Friday schedule (25 mg/m² on Mondays, 25 mg/m² on Wednesdays, 50 mg/m² on Fridays) or a 48-hourly schedule (25 mg/m² once every 48 hours), with each dose given either intramuscularly (IM) or intravenously (IV). Nadir (pre-dose/trough) serum asparaginase activity (NSAA) must be monitored and dosing adjusted in accordance with local treatment protocols. An NSAA of <0.1 U/mL is associated with loss of efficacy. No dose adjustment is required in paediatric patients. No dose adjustment is required in elderly patients.

Key safety warnings

Hypersensitivity reactions were very common in clinical trials, with the risk being higher with intravenous than intramuscular administration; severe events occurred in 8% of patients, including anaphylaxis in 2% of patients. Drug hypersensitivity led to discontinuation for 10% of patients. Enrylaze must be administered in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis. Premedication (paracetamol, an H1 receptor blocker, and an H2 receptor blocker) should be administered 30–60 minutes prior to Enrylaze to decrease the risk and severity of hypersensitivity reaction. Pancreatitis was reported in 7% of patients in clinical trials, with serious events in 5% and life-threatening events in 1%. Patients should be informed of the signs and symptoms of pancreatitis, and that if left untreated pancreatitis can be fatal. Serious thrombotic events including sagittal sinus thrombosis and pulmonary embolism were reported in 1% of patients. Haemorrhage was reported in 18% of patients, with severe haemorrhage in 2%; the most commonly reported haemorrhage-related events were contusion (10%), epistaxis (8%), petechiae (3%) and menorrhagia (1%). Elevated transaminases occurred in 29% of patients (17% Grade 3 or higher), and elevated blood bilirubin in 10% of patients (2% Grade 3 or higher). Hepatic veno-occlusive disease (VOD), which can be fatal, can occur with asparaginase-containing regimens; it may present with rapid weight gain, fluid retention with ascites, hepatomegaly, rapid increase of bilirubin, refractory thrombocytopenia and multiorgan dysfunction. Cases of glucose intolerance have been reported in patients receiving Enrylaze in clinical trials.

Contraindications

Enrylaze is contraindicated in patients with history of severe hypersensitivity reactions to the active substance, hypersensitivity to any of the excipients, severe pancreatitis, history of severe pancreatitis during previous asparaginase therapy, severe thrombosis during previous asparaginase therapy, and severe haemorrhagic events during previous asparaginase therapy.

Regulatory history

Enrylaze received TGA approval on 2025-04-10. The medicine was first listed on the ARTG on 2025-04-16 as a recombinant crisantaspase 10 mg/0.5 mL solution for injection/infusion vial.