Enrylaze
Recombinant Crisantaspase for Acute Lymphoblastic Leukaemia and Lymphoblastic Lymphoma
Quick Facts About Enrylaze
Key Takeaways About Enrylaze
- Cancer treatment enzyme: Enrylaze depletes asparagine, starving ALL and LBL cancer cells that cannot produce this amino acid on their own
- Recombinant formulation: Produced using recombinant DNA technology, offering an alternative for patients with hypersensitivity to E. coli–derived asparaginase
- Hospital-administered only: Given as an IV infusion over 2 hours or by intramuscular injection under medical supervision with monitoring for allergic reactions
- Serious risks require monitoring: Patients are closely monitored for pancreatitis, thrombosis, bleeding, liver toxicity, and hyperglycaemia during treatment
- Contraception essential: Both men and women must use effective contraception during treatment and for 3 months after the last dose; hormonal contraceptives are not recommended
What Is Enrylaze and What Is It Used For?
Enrylaze (recombinant crisantaspase) is an antineoplastic enzyme used together with other chemotherapy drugs to treat acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL) in patients aged 1 month and older. It works by breaking down asparagine, an amino acid that these cancer cells need to grow and survive.
Acute lymphoblastic leukaemia (ALL) is a type of cancer that affects the white blood cells. It is the most common cancer in children, but can also occur in adults. In ALL, the bone marrow produces too many immature white blood cells (lymphoblasts) that crowd out normal blood cells, leading to anaemia, increased risk of infections, and abnormal bleeding. Lymphoblastic lymphoma (LBL) is a closely related malignancy that primarily affects the lymph nodes and other lymphoid tissues rather than the bone marrow.
The active substance in Enrylaze is recombinant crisantaspase, a protein produced in the laboratory using recombinant DNA technology. This enzyme is derived from the bacterium Erwinia chrysanthemi (now reclassified as Dickeya chrysanthemi) and is manufactured in Pseudomonas fluorescens expression systems. The recombinant production method ensures consistent quality and reliable supply compared to earlier products derived directly from bacterial fermentation.
Enrylaze works through a specific and well-understood mechanism of action. All cells require the amino acid asparagine for normal protein synthesis and cellular function. Most healthy cells in the body possess the enzyme asparagine synthetase, which enables them to manufacture their own asparagine internally. However, ALL and LBL cancer cells typically lack sufficient asparagine synthetase activity and therefore depend almost entirely on the circulating supply of asparagine in the bloodstream for their survival.
By catalysing the hydrolysis of L-asparagine into L-aspartic acid and ammonia, Enrylaze rapidly depletes asparagine from the blood. This selective depletion preferentially affects the cancer cells, which cannot compensate by making their own asparagine. The resulting asparagine starvation triggers apoptosis (programmed cell death) in the leukaemia and lymphoma cells, while normal cells – which can synthesise asparagine independently – are largely spared.
Asparaginase therapy has been a cornerstone of ALL treatment protocols since the 1970s. The most commonly used formulations have historically been derived from E. coli bacteria (including pegaspargase, a PEGylated form). However, some patients develop hypersensitivity reactions to E. coli–derived asparaginase, which can prevent them from continuing this critical component of their chemotherapy regimen. Enrylaze provides an immunologically distinct alternative derived from a different bacterial source, allowing these patients to continue receiving asparaginase therapy and maintain asparagine depletion throughout their treatment course.
What Should You Know Before Receiving Enrylaze?
Before receiving Enrylaze, your medical team must evaluate your complete medical history, including any prior reactions to asparaginase products, history of pancreatitis, blood clotting disorders, and liver function. Several conditions may prevent you from receiving this medication or require special precautions.
Contraindications
You must not receive Enrylaze if any of the following apply to you:
- Serious allergic reaction to Enrylaze – if you have previously experienced a severe hypersensitivity reaction specifically to Enrylaze or any of its components
- Current severe pancreatitis – active inflammation of the pancreas is an absolute contraindication due to the high risk of worsening this potentially life-threatening condition
- History of severe pancreatitis following asparaginase therapy – patients who developed severe pancreatitis after previous treatment with any asparaginase product should not receive Enrylaze
- History of serious thrombosis with prior asparaginase – previous severe blood clotting events related to asparaginase treatment preclude use of Enrylaze
- History of serious haemorrhagic events with prior asparaginase – severe bleeding episodes linked to previous asparaginase therapy are a contraindication
Severe allergic reactions, including life-threatening anaphylaxis, can occur during Enrylaze treatment. Your healthcare team will ensure that emergency resuscitation equipment and medications are available at the treatment site. You will be monitored closely during and after each administration for signs of allergic reactions.
Warnings and Precautions
The following complications can occur during treatment with Enrylaze, and your medical team will monitor you carefully for these conditions:
- Severe allergic reactions: Anaphylaxis and other serious hypersensitivity reactions can be life-threatening. The hospital will be fully prepared to manage allergic reactions that may occur during treatment. Symptoms to watch for include facial swelling, difficulty breathing, widespread hives, wheezing, flushing, vomiting, and changes in blood pressure.
- Pancreatitis (inflammation of the pancreas): Discomfort or pain in the abdominal area or back may indicate pancreatitis and should be reported to your doctor immediately. Pancreatitis can range from mild to severe and, in rare cases, can be fatal. Your medical team will monitor pancreatic enzyme levels regularly.
- Blood sugar disturbances: Enrylaze can affect the body’s ability to regulate blood glucose levels, potentially causing hyperglycaemia (high blood sugar). Your glucose levels will be monitored throughout treatment, and insulin therapy may be initiated if necessary.
- Unusual bleeding or blood clots: Asparaginase therapy affects the production of clotting factors in the liver, which can lead to either bleeding complications or paradoxical blood clot formation (thrombosis). If bleeding or thrombosis occurs, your doctor will pause treatment until the issue resolves. Blood clots can form in the lungs (pulmonary embolism), brain, or deep veins of the legs.
- Liver problems: Enrylaze can cause hepatotoxicity, including elevated liver enzymes, increased bilirubin, and reduced albumin production. Your liver function will be monitored regularly throughout the treatment course.
- Central nervous system effects: Neurological complications, including seizures and impaired neurological function, have been reported. Posterior reversible encephalopathy syndrome (PRES), characterised by headache, confusion, seizures, and visual loss, may require blood pressure–lowering medications and anti-epileptic treatment.
Monitoring During Treatment
You will be monitored during and after treatment with Enrylaze for:
- Allergic reactions during and after each infusion or injection
- Pancreatic function (amylase and lipase levels)
- Liver function tests (transaminases, bilirubin, albumin)
- Blood glucose levels
- Coagulation parameters (fibrinogen, antithrombin III, activated partial thromboplastin time)
- Complete blood count and differential
Pregnancy and Breastfeeding
Enrylaze must not be used during pregnancy. Women of childbearing potential must undergo a pregnancy test before starting treatment. Based on the mechanism of action and the nature of chemotherapy regimens in which Enrylaze is used, the drug may cause harm to an unborn baby.
Breastfeeding must be discontinued during treatment with Enrylaze and for two weeks after the last dose, as the drug may pose a risk to the nursing infant. The potential for excretion into breast milk has not been fully established, and a precautionary approach is warranted given the nature of the medication.
Contraception: Both men and women must use effective contraception during treatment and for 3 months after the last dose of Enrylaze. Importantly, hormonal contraceptives are not recommended for women receiving Enrylaze, as asparaginase therapy can affect the metabolism and efficacy of hormonal contraception. Non-hormonal barrier methods or intrauterine devices should be used instead.
Driving and Operating Machinery
Enrylaze can cause nausea, headache, dizziness, and fatigue, which may impair your ability to drive or operate machinery. You should not drive or use machines if you experience any of these symptoms during treatment. Given that Enrylaze is administered in a hospital or clinic setting as part of intensive chemotherapy, most patients will not be driving themselves to or from treatment sessions.
How Does Enrylaze Interact with Other Drugs?
Enrylaze can interact with several chemotherapy agents, including methotrexate, cytarabine, vincristine, and glucocorticoids. These interactions are carefully managed within standard chemotherapy protocols, but it is essential to inform your doctor about all medications you are receiving.
Because Enrylaze is always used as part of a multi-agent chemotherapy regimen, drug interactions are an important consideration for your oncology team. Asparaginase enzymes can affect the metabolism and efficacy of other drugs through their impact on protein synthesis and hepatic function. The following table summarises the most clinically significant interactions.
Major Interactions
| Drug | Category | Effect | Recommendation |
|---|---|---|---|
| Methotrexate | Antimetabolite chemotherapy | Administration immediately before Enrylaze may increase the effect and toxicity of methotrexate due to reduced protein synthesis affecting drug clearance | Timing of administration is carefully sequenced within treatment protocols |
| Cytarabine | Antimetabolite chemotherapy | Administration immediately before Enrylaze may increase cytarabine’s effects and toxicity | Administer according to protocol-specified sequencing |
| Vincristine | Vinca alkaloid chemotherapy | Concurrent use may increase vincristine neurotoxicity due to reduced hepatic clearance | Monitor closely for peripheral neuropathy; administer vincristine before Enrylaze when possible |
| Glucocorticoids (e.g. dexamethasone, prednisone) | Anti-inflammatory / immunosuppressive | Use immediately before Enrylaze may increase the risk of thrombosis (blood clots) | Monitor coagulation parameters closely; thromboprophylaxis may be considered |
Other Important Considerations
Enrylaze’s impact on hepatic protein synthesis can broadly affect the metabolism and pharmacokinetics of other drugs. Asparaginase therapy reduces the production of several liver-synthesised proteins, including coagulation factors, albumin, and certain drug-metabolising enzymes. This means that the clearance and distribution of other concurrently administered medications may be altered.
Patients receiving Enrylaze should inform their medical team about all medications they are taking, including:
- Other cancer treatments
- Anticoagulants (blood thinners) and antiplatelet drugs
- Hormonal medications (including oral contraceptives)
- Antiepileptic drugs
- Over-the-counter medications and supplements
Because Enrylaze is administered in controlled clinical settings, your oncology team will be fully aware of potential interactions and will manage drug sequencing and monitoring accordingly. Do not start any new medication without consulting your treatment team first.
What Is the Correct Dosage of Enrylaze?
Enrylaze dosing is determined by your doctor based on your condition, body surface area, route of administration, and treatment protocol. It is given either as an intravenous infusion over 2 hours or as an intramuscular injection, always in a hospital or clinic setting.
Enrylaze is not a medication that patients self-administer. It is always given by healthcare professionals in a controlled clinical environment as part of a structured chemotherapy protocol. The dose and administration route are determined by your oncologist based on several factors including the specific treatment protocol, your body surface area, your clinical condition, and how you respond to therapy.
Administration Routes
Intravenous (IV) Infusion
When given intravenously, Enrylaze is diluted in a suitable infusion solution and administered over a 2-hour period. The infusion rate is carefully controlled, and you will be monitored for allergic reactions throughout the infusion and for an appropriate period afterwards. Pre-medications such as paracetamol (acetaminophen), H1-receptor antagonists (antihistamines), and H2-receptor antagonists may be given before the infusion to reduce the risk of infusion-related reactions.
Intramuscular (IM) Injection
When given intramuscularly, Enrylaze is injected directly into the muscle. Multiple injection sites may be used to distribute the volume of the medication. This route may be preferred in certain clinical situations or when IV access is challenging. The same pre-medication protocols typically apply.
Dose Adjustments
Your doctor will adjust the dose and schedule of Enrylaze based on:
- Body surface area (BSA): Dosing is calculated individually based on your height and weight
- Treatment protocol: The specific chemotherapy regimen dictates dosing frequency and total number of doses
- Therapeutic drug monitoring: Serum asparaginase activity levels may be measured to ensure adequate asparagine depletion
- Side effects: If you experience significant adverse effects, your doctor may modify the dose, delay treatment, or discontinue Enrylaze
Missed Dose
Since Enrylaze is administered in a hospital or clinic setting by healthcare professionals, missed doses are uncommon. However, if a scheduled dose is delayed or missed for any reason, contact your doctor or treatment team immediately. They will advise on the appropriate course of action based on your treatment protocol and clinical situation. Do not attempt to double up on doses.
Overdose
If you are concerned about the dose you received, or if you experience unusual symptoms after treatment, contact your doctor or healthcare team immediately. Because Enrylaze is administered by healthcare professionals in a controlled setting, the risk of accidental overdose is low. There is no specific antidote for Enrylaze overdose; management would be supportive, focusing on monitoring and treating any symptoms that develop.
What Are the Side Effects of Enrylaze?
Like all medicines, Enrylaze can cause side effects, although not everyone experiences them. The most common side effects include allergic reactions, low blood cell counts, nausea, fatigue, and elevated blood sugar. Serious side effects such as anaphylaxis, pancreatitis, and blood clots require immediate medical attention.
It is important to understand that Enrylaze is used as part of multi-agent chemotherapy, and many side effects may result from the combined effects of all drugs in the treatment regimen rather than Enrylaze alone. Your medical team will monitor you closely throughout treatment and manage side effects as they arise. Report any new or worsening symptoms to your healthcare team promptly.
Signs of a severe allergic reaction (facial swelling, difficulty breathing, hives, wheezing, flushing, vomiting, rapid or slow heartbeat, fainting); signs of blood clots (sudden shortness of breath, chest pain, coughing up blood, weakness or numbness on one side, severe headache, difficulty speaking); or signs of pancreatitis (severe abdominal pain, nausea, vomiting, back pain, loss of appetite).
Very Common
- Allergic reactions (including skin rash, itching, urticaria/hives)
- Infections
- Low red blood cells (anaemia)
- Low platelets (thrombocytopenia)
- Low white blood cells (leukopenia, neutropenia, lymphopenia)
- Febrile neutropenia (low neutrophils with fever from infection)
- Abdominal pain
- Diarrhoea
- Nausea and vomiting
- Fatigue
- Fever (pyrexia)
- High blood sugar (hyperglycaemia)
- Pain in arms and legs (extremity pain)
- Weight loss
- Headache
- Decreased appetite
- Abnormal liver function tests (elevated transaminases, elevated bilirubin)
- Low albumin levels (hypoalbuminaemia)
- Anxiety
- Bruising (contusion)
Common
- Sepsis (blood poisoning)
- Anaphylactic reaction (severe allergic reaction with breathing difficulty, swelling, fainting, rapid pulse)
- Maculopapular rash (flat discoloured patches and raised red spots)
- Erythematous rash (rash with redness and inflammation)
- Urticaria (hives)
- Pruritus (itchy skin)
- Pancreatitis (inflammation of the pancreas)
- Injection site pain and reactions
- Infusion-related reactions
- Abnormal coagulation (prolonged aPTT, decreased antithrombin III, decreased fibrinogen)
- Abnormal kidney function (elevated creatinine)
- Low blood sugar (hypoglycaemia)
- Low blood pressure (hypotension)
- Blood clots, including in the lungs and brain
- Irritability
- Dizziness
Uncommon
- Blood clot in a major vein of the brain (superior sagittal sinus thrombosis)
- Blood clot in the jugular vein (jugular vein thrombosis)
- Deep vein thrombosis in the arms or legs
Reporting Side Effects
Reporting suspected side effects after a medicine has been authorised is important, as it allows continued monitoring of the benefit-risk balance. Healthcare professionals and patients are encouraged to report any suspected adverse reactions through their national pharmacovigilance system. In the EU, reports can be submitted to the national competent authority or through the European Medicines Agency. In the US, adverse events should be reported to the FDA MedWatch programme.
How Should Enrylaze Be Stored?
Unopened Enrylaze vials must be stored in a refrigerator at 2–8°C in an upright position, protected from light. Do not freeze. After preparation, specific time limits apply depending on the storage conditions.
Proper storage of Enrylaze is critical to maintaining the stability and efficacy of this biological product. While patients do not typically handle the storage of Enrylaze themselves (as it is administered in healthcare settings), understanding the storage requirements can help ensure that the medication is used safely.
- Unopened vials: Store in a refrigerator at 2°C to 8°C in an upright position. Keep the vials in the outer carton to protect from light. Do not freeze.
- After preparation in a syringe: Enrylaze can be stored for up to 8 hours at room temperature (15–25°C) or 24 hours refrigerated (2–8°C).
- After dilution in an IV bag: Enrylaze can be stored for up to 12 hours at room temperature (15–25°C) or 24 hours refrigerated (2–8°C). Storage time begins from the moment the solution is withdrawn from the unopened vial.
- Visual inspection: Do not use the medication if you notice particles in the solution. The solution should appear clear to slightly yellow.
Keep this medication out of the sight and reach of children. Do not use after the expiry date printed on the carton and vial label (after “EXP”). The expiry date refers to the last day of the stated month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer needed to help protect the environment.
What Does Enrylaze Contain?
Each vial of Enrylaze contains 10 mg of recombinant crisantaspase in 0.5 mL of solution. The inactive ingredients include trehalose dihydrate, sodium chloride, sodium hydroxide, disodium phosphate, sodium dihydrogen phosphate monohydrate, polysorbate 80, and water for injections.
Active Ingredient
The active substance is recombinant crisantaspase. Each glass vial contains 10 mg of recombinant crisantaspase in 0.5 mL of solution for injection/infusion. Recombinant crisantaspase is an asparaginase enzyme produced using recombinant DNA technology in Pseudomonas fluorescens, based on the sequence from Erwinia chrysanthemi (now classified as Dickeya chrysanthemi).
Inactive Ingredients (Excipients)
The other ingredients in Enrylaze are:
- Trehalose dihydrate – a sugar used as a stabiliser to protect the protein during storage
- Sodium chloride – to adjust the tonicity of the solution
- Sodium hydroxide – for pH adjustment
- Disodium phosphate – a buffering agent
- Sodium dihydrogen phosphate monohydrate – a buffering agent
- Polysorbate 80 – a surfactant to prevent protein aggregation
- Water for injections – the solvent
This medicine contains less than 1 mmol (23 mg) sodium per dose, meaning it is essentially sodium-free. This is important information for patients on a controlled sodium diet.
Packaging and Appearance
Enrylaze is a clear to slightly yellow solution for injection/infusion, free from visible particles. Each carton contains 3 glass vials, each containing 0.5 mL of solution. The marketing authorisation is held by Jazz Pharmaceuticals Ireland Ltd, Dublin, Ireland.
Frequently Asked Questions About Enrylaze
Enrylaze (recombinant crisantaspase) is used as part of a multi-agent chemotherapy regimen to treat acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL) in patients aged 1 month and older. It is an asparaginase enzyme that depletes asparagine, an amino acid that ALL and LBL cancer cells require for survival. By removing this amino acid from the blood, Enrylaze starves the cancer cells while sparing normal cells that can produce their own asparagine.
Enrylaze is a recombinant form of crisantaspase derived from Erwinia chrysanthemi bacteria, produced using recombinant DNA technology. Unlike the more commonly used E. coli–derived asparaginase products (such as pegaspargase), Enrylaze is immunologically distinct. This means it can be used as an alternative for patients who have developed hypersensitivity to E. coli–derived products, allowing them to continue receiving asparaginase therapy as part of their treatment protocol.
The most serious risks include severe allergic reactions (including anaphylaxis), pancreatitis, blood clots (thrombosis including pulmonary embolism and cerebral thrombosis), serious bleeding events, liver toxicity, hyperglycaemia, and neurological complications such as seizures and posterior reversible encephalopathy syndrome (PRES). Patients are monitored closely during and after each treatment for early signs of these complications.
No, hormonal contraceptives are not recommended for women receiving Enrylaze. Asparaginase therapy can affect the liver’s production of proteins involved in the metabolism and efficacy of hormonal contraceptives, potentially reducing their effectiveness. Non-hormonal methods of contraception, such as barrier methods (condoms, diaphragms) or copper intrauterine devices (IUDs), should be used instead. Both men and women must use effective contraception during treatment and for 3 months after the last dose.
When given intravenously, Enrylaze is infused over a period of 2 hours. You may also receive pre-medications before the infusion, such as paracetamol and antihistamines, to help prevent infusion-related reactions. After the infusion is complete, you will be monitored for a period of time for any adverse reactions before being discharged. When given intramuscularly, the injection itself is much quicker, but you will still be monitored afterwards.
Unopened Enrylaze vials must be stored in a refrigerator at 2–8°C in an upright position, protected from light in the outer carton. The medication must not be frozen. After preparation in a syringe, it can be used within 8 hours at room temperature or 24 hours refrigerated. After dilution in an IV bag, it remains stable for up to 12 hours at room temperature or 24 hours refrigerated. Storage of Enrylaze is typically managed by healthcare professionals in the hospital pharmacy.
References and Sources
- European Medicines Agency (EMA). Enrylaze – Summary of Product Characteristics. Available from: EMA EPAR for Enrylaze. Last updated 2023.
- U.S. Food and Drug Administration (FDA). Enrylaze Prescribing Information. Jazz Pharmaceuticals, Inc. Approved June 2022.
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Acute Lymphoblastic Leukemia. Version 2.2024.
- Salzer W, et al. “Asparaginase activity levels and monitoring in patients with acute lymphoblastic leukemia.” Leukemia & Lymphoma. 2014;55(8):1797–1806. doi:10.3109/10428194.2013.861865
- Pieters R, et al. “L-asparaginase treatment in acute lymphoblastic leukemia: a focus on Erwinia asparaginase.” Cancer. 2011;117(2):238–249. doi:10.1002/cncr.25489
- World Health Organization (WHO). WHO Model List of Essential Medicines. 23rd List (2023). Asparaginase listed as an essential cancer medicine.
- British National Formulary (BNF). Crisantaspase. Available at: bnf.nice.org.uk. Accessed January 2026.
- Aldoss I, et al. “Asparaginase in Adults with Acute Lymphoblastic Leukemia: An Expert Review.” Blood Advances. 2022;6(12):3680–3691. doi:10.1182/bloodadvances.2021006325
Our Medical Editorial Team
This article has been written, fact-checked, and medically reviewed by the iMedic Medical Editorial Team, which includes specialist physicians in oncology, haematology, and clinical pharmacology. Our team follows international guidelines from the WHO, EMA, FDA, and NCCN.