Patient leaflet - Enrylaze 10 mg/0.5 ml solution for injection/infusion

1. What Enrylaze is and what it is used for 2. What you need to know before you are given Enr 3. How Enrylaze is given

ylaze

4. Possible side effects
5. How Enrylaze is stored
6. Contents of the pack and other information
1. What Enrylaze is and what it is used for

Enrylaze contains the active substance recombinan medicine used alongside other medicines to treat a leukaemia (ALL) and lymphoblastic lymphoma (LBL to patients aged 1 months of age or older. Enrylaze contains a protein made in the laboratory technology. This protein works by decreasing the am asparagine. This protein is needed by the ALL and survive.

t crisantaspase. It is a cute lymphoblastic

). Enrylaze can be given by recombinant DNA ount of a protein called LBL cancer cells to

2. What you need to know before you are give

n Enrylaze

You should not receive Enrylaze

if you have a severe allergic reaction to Enrylaze • if you have an allergic reaction to any of the oth
.
er ingredients of this medicine (listed in section 6).
if you are currently experiencing severe pancreat
itis (inﬂammation of the pancreas).
if you have experienced severe pancreatitis after asparaginase therapies.
being treated with
if you have experienced serious blood clots after asparaginase therapies.
being treated with
if you have experienced serious bleeding events asparaginase therapies.
after being treated with

Warnings and precautions

Talk to your doctor or pharmacist before you receive The following problems may occur during treatment • serious allergic reactions that may be life-threat

Enrylaze.

with Enrylaze:

ening. The hospital will reactions that may occur

ensure they are prepared to address any allergic during treatment.

inﬂammation of your pancreas. Discomfort or pa
in in your stomach or back reported to your doctor
area may be a sign of pancreatitis and should be straight away.
changes in your body’s ability to manage blood s
ugar levels. Your doctor tment and provide insulin
should monitor your glucose levels whilst on trea if necessary.
unusual bleeding events or blood clots. If either
of these events occur, y are resolved.
treatment will be paused by your doctor until the • issues with your liver. Your doctor will monitor yo
u to identify if you are you as necessary.
experiencing any issues with your liver and treat • central nervous system toxicity, such as seizures
and impaired neurological ncephalopathy syndrome and loss of vision) may n case of seizure,
function. Also, instances of posterior reversible e (characterised by headache, confusion, seizures require blood-pressure lowering medicines and i treatment with anti-epileptic medicines.

Monitoring during treatment with Enrylaze

You will be monitored during and after treatment wi • allergic reactions

th Enrylaze for:

functioning of your pancreas and liver • blood sugar levels

Other medicines and Enrylaze

Tell your doctor or pharmacist if you are taking, hav take any other medicines. In particular, inform your you have or are receiving:

e recently taken or might doctor or pharmacist if

methotrexate or cytarabine, used in cancer treat
ment. Use of these medicines immediately before Enrylaze may incr • vincristine, used in cancer treatment. Use of vin
ease their effect.
cristine with Enrylaze may increase the toxicity of vincristine.
glucocorticoids, used as anti-inﬂammation medi
cines. Use of these medicines immediately before Enrylaze may incr blood clots.
ease the formation of

Pregnancy

Enrylaze should not be used during pregnancy, and they are not pregnant prior to starting therapy. If yo you may be pregnant, ask your doctor or pharmacis receiving this medicine.

women should check that u are pregnant or think t for advice before

Breast-feeding

You should not breast-fe treatment with Enrylaze,

ed during treatment and for two weeks following as there may be a risk to the breast-feeding child.

Family planning

Both men and women sh conceiving a child during last receive Enrylaze. Ho in women when being tre Women should undergo

ould use a form of contraception and avoid treatment with Enrylaze and for 3 months after you rmonal contraceptives are not recommended for use ated with Enrylaze.

pregnancy testing before starting treatment.

Driving and using machine

Enrylaze can cause you t your ability to drive and

o feel sick and have a headache. This may impact operate machines.

Enrylaze contains sodium

This medicine contains l is to say, essentially, ‘sod

ess than 1 mmol sodium (23 mg) per dose unit, that ium free’.

Enrylaze contains polysor

bate 80

This medicine contains 0 which is equivalent to 0. reaction. Tell your doctor

.1 mg of polysorbate 80 in each vial of Enrylaze 2 mg/mL. Polysorbates may cause an allergic if you have any known allergies.

3. How Enrylaze is giv

Your doctor will determin given to you by an infusi You may also be given so Enrylaze, such as parace The dose and how it is g body surface area and re If you are given Enrylaze period.

e what dose you are given and whether it will be on into your veins or an injection into your muscle. me other medicines before you start receiving tamol H1 and H2 blocker.

iven may vary depending on your speciﬁc condition, sponse to therapy.

into your veins, this will be given over a 2-hour

If you are given Enrylaze

into a muscle, several injection sites may be used.

If you think you have been

given more Enrylaze than you should

If you have any concerns immediately.

, contact your doctor or any healthcare professional

If you think you have miss

ed a dose of Enrylaze

If you have any concerns immediately.

, contact your doctor or any healthcare professional

4. Possible side effec

Like all medicines, this everybody gets them. For effects were reported.

medicine can cause side effects, although not patients treated with Enrylaze the following side

Serious side effects

Tell your doctor immediat

ely if you experience:

Symptoms of a serious a shortness of breath, hay vomiting, high or low blo severe allergic reaction w fast heartbeat, sweating Symptoms of blood clots could present as sudden blood and the blood vess such as weakness/numb Symptoms of pancreatiti pain, or loss of appetite.

llergic reaction, including swelling of the face, fever like symptoms, rash, chills, wheezing, ﬂushing, od pressure. In severe cases anaphylaxis (a sudden, ith breathing difﬁculty, swelling, light-headedness, and loss of consciousness) can also occur. , including in the blood vessels of the lung which shortness of breath, chest pain, or coughing up els of the brain which could present with symptoms ness, seizure, trouble speaking, or severe headache. s, including abdominal pain, nausea, vomiting, back

Other side effects

Talk to your doctor if you Very common side effects • allergic reaction, incl • infections

get any of the following:

(may affect more than 1 in 10 people): uding rash, itching, and hives

low levels of red bloo • low levels of blood pl • low levels of white blo • low levels of neutroph
d cells (anaemia)
atelets (thrombocytopenia)
od cells (white blood cell count decreased) ils, a type of white blood cell that ﬁghts off infection
(neutropenia)
low levels of white blo
od cells (neutrophils) with fever due to infection
(febrile neutropenia) • low levels of lymphoc
ytes, a type of white blood cell that ﬁghts off count decreased)
infection (lymphocyte • pain in your stomach • diarrhoea
(abdominal pain)
feeling sick (nausea) • vomiting
tiredness (fatigue) • fever (pyrexia)
high blood sugar level • pain in limbs (pain in • weight loss (weight de • headache
s (hyperglycaemia)
extremity)
creased)
decreased appetite • abnormal liver functio
n test (transaminases increased, blood bilirubin increased)
decreased albumin (a • anxiety
blood protein) level (hypoalbuminaemia)
bruising (contusion)

Common side effects (ma • blood poisoning (seps • sudden, severe allergi

y affect up to 1 in 10 people):

is)

c reaction with breathing difﬁculty, swelling, heartbeat, sweating and loss of consciousness )

lightheadedness, fast (anaphylactic reaction • skin rash characterize

d with ﬂat, discolored patches (macules) and raised, ules) (rash maculo-papular)

reddened bumps (pap • skin rash with rednes • hives (urticaria)

s and inﬂamation (rash erythematous)

08000420G00800

043L00-M040U3015

itchy skin (pruritus)
inﬂammation of the pancreas (pancreatitis) • injection site pain
injection site reaction
infusion related reactions
abnormal blood clotting factor levels (prolonged a
ctivated partial thromboplastin time, decreased antithrombin III, ﬁbrinogen)
decreased blood
abnormal kidney function (increased blood creatin • low blood sugar levels (hypoglycaemia) • low blood pressure (hypotension)
ine)
blood clots, including in the blood vessels of the l • irritability
ung and brain
dizziness

Uncommon side effects (may affect up to 1 in 100 pe • blood clot in a major brain vein (superior sagittal • blood clot in the neck vein (jugular vein thrombos • blood clot in extremity veins (deep vein thrombosi

ople)

sinus thrombosis)

is)

Reporting of side effects

If you get any side effects, talk to your doctor or phar any possible side effects not listed in this leaﬂet. You effects directly via:

macist. This includes can also report side

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for M Google Play or Apple App Store

HRA Yellow Card in the

By reporting side effects, you can help provide more of this medicine.

information on the safety

5. How Enrylaze will be stored

Keep this medicine out of the sight and reach of chil Do not use this medicine after the expiry date which and vial after EXP. The expiry date refers to the last d Store the unopened vials in a refrigerator (2 °C–8 °C) Do not freeze. Keep the vial in the outer carton in or After preparing a dose in a syringe, Enrylaze can be s at room temperature (15°C–25 °C) or 24 hours when (2 °C–8 °C).

dren.

is stated on the carton ay of that month.

in an upright position. der to protect from light. tored for up to 8 hours refrigerated

After dilution in an intravenous bag, Enrylaze can be hours at room temperature (15 °C–25 °C) or 24 hour (2 °C–8 °C). Storage time starts once the solution ha the unopened vials.

stored for up to 12 s when refrigerated s been withdrawn from

Do not use this medicine if you notice any particles i Do not throw away any medicines via wastewater. Ask throw away medicines you no longer use. These mea the environment.

n the solution.

your pharmacist how to sures will help protect

6. Contents of the pack and other information

What Enrylaze contains

The active substance is recombinant crisantaspas
e. Each vial contains lution.
10 mg of recombinant crisantaspase in 0.5 mL so • The other ingredients are trehalose dihydrate, sod
ium chloride (see section 2 “Enrylaze contains sodium”), sodium hy adjustment), disodium phosphate, sodium dihydr monohydrate, polysorbate 80 and water for injecti
droxide (for pH ogen phosphate ons.

What Enrylaze looks like and contents of the pack

Enrylaze is a clear to slightly yellow solution for injec particulate matter.

tion/infusion, free from

One carton contains 3 glass vials, each with 0.5 mL injection/infusion.

of solution for

Marketing Authorisation Holder and Manufacturer

Jazz Pharmaceuticals UK Limited

80 Charlotte Street

London, W1T 4DF

United Kingdom

Tel: +44 8081890387

Email: medinfo-uk@jazzpharma.com

This leaﬂet was last revised in: May 2026.

XXXXX-XX PXXXXX/XY

FRONT

/ RECTO

WRK DWG 2023_0063

Prescription needed?	Yes, prescription-only medicine (POM)
Active substance	Crisantaspase
Strength	10 mg/0.5 ml (20 mg/ml)
Pharmaceutical form	Solution for injection Clear to opalescent, colourless to slightly yellow solution with a pH of 7.0 ± 0.5 and an osmolality: 290–350 mOsmol/kg.
How is it taken	Intravenous, Intramuscular
Excipients	Trehalose dihydrate, Sodium chloride, Sodium hydroxide (for pH adjustment), Disodium phosphate, Sodium dihydrogen phosphate monohydrate, Polysorbate 80, Water for injection
Pack sizes	3 vial
Is it available?	Listed as available (NHS Dictionary of Medicines and Devices – not a record of current supplies)
Shelf life	Unopened vial 4 years. In-use stability data 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).
Storage	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.
Drug group (ATC)	Other antineoplastic agents L Antineoplastic and immunomodulating agents L01 Antineoplastic agents L01X Other antineoplastic agents L01XX Other antineoplastic agents L01XX02 asparaginase
Additional monitoring	Yes ▼ – new safety information is collected quickly. Report any side effect to the Yellow Card scheme.
Marketing authorisation	PLGB 31626/0007 (first authorised 30 January 2024)
Marketing authorisation holder	Jazz Pharmaceuticals UK Limited
Codes	GTIN 0368727007246 · BNF 08010500

Enrylaze 10 mg/0.5 mL solution for injection/infusion – patient leaflet, side effects, dosage