ENRYLAZE 20 mg /Ml Инъекционный Или Инфузионный Раствор

Содержание инструкции

1. Enrylaze 10 mg/0.5 mL injectable solution or for infusion
   1. What is Enrylaze and what is it used for
   2. What you need to know before using Enrylaze
   3. How to use Enrylaze
   4. Possible side effects
   5. How to store Enrylaze
   6. Contents of the pack and other information

Enrylaze 10 mg/0.5 mL injectable solution or for infusion

recombinant asparaginase

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Enrylaze is and what it is used for
• 2. What you need to know before you use Enrylaze
• 3. How to use Enrylaze
• 4. Possible side effects
• 5. How to store Enrylaze
• 6. Contents of the pack and other information

1. What is Enrylaze and what is it used for

Enrylaze contains the active substance recombinant chrysantaspase. It is a medicine used together with other
medicines for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LL).
Enrylaze can be administered to patients aged 1 month or older.
Enrylaze contains a protein produced in the laboratory using recombinant DNA technology.
This protein works by reducing the amount of a protein called asparagine. This protein is
necessary for the cancer cells of ALL and LL to survive.

2. What you need to know before using Enrylaze

Do not use Enrylaze

• if you experience a severe allergic reaction to Enrylaze.
• if you experience an allergic reaction to any of the other ingredients of this medicine (listed in section 6).
• if you currently suffer from severe pancreatitis (inflammation of the pancreas).
• if you have suffered from severe pancreatitis after being treated with therapies based on asparaginase.
• if you have experienced severe blood clots after being treated with therapies based on asparaginase.
• if you have experienced severe bleeding events after being treated with therapies based on asparaginase.

Warnings and precautions
Talk to your doctor or pharmacist before using Enrylaze.
The following problems may occur during treatment with Enrylaze:

• severe allergic reactions that may be life-threatening. The hospital will ensure that it

is prepared to deal with any allergic reactions that may occur during
treatment.

• inflammation of the pancreas. Discomfort or pain in the stomach area or back may be a sign of pancreatitis and should be reported to your doctor immediately.
• changes in your body's ability to manage blood sugar levels. Your doctor should monitor glucose levels during treatment and provide insulin if necessary.
• unusual bleeding or blood clots. If any of these events occur, your doctor will suspend treatment until they resolve.
• liver problems. Your doctor will monitor you to identify if you are experiencing liver problems and will treat you as needed.
• toxicity at the central nervous system level, such as seizures and impaired neurological function. In addition, cases of reversible posterior encephalopathy syndrome (characterized by headache, confusion, seizures, and vision loss) may require medications to lower blood pressure and, in the event of seizures, treatment with antiepileptic drugs.

Monitoring during treatment with Enrylaze
You will be monitored during and after treatment with Enrylaze for:

• allergic reactions
• pancreas and liver function
• blood sugar levels

Other medicines and Enrylaze
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines. In particular, tell your doctor or pharmacist if you have used or are using:

• methotrexate or cytarabine, used in the treatment of cancer. Using these medicines immediately before Enrylaze may increase its effect.
• vincristine, used in the treatment of cancer. Using vincristine with Enrylaze may increase the toxicity of vincristine.
• glucocorticoids, used as anti-inflammatory medicines. Using these medicines immediately before Enrylaze may increase the formation of blood clots.

Pregnancy
Enrylaze should not be used during pregnancy and women must verify that they are not
pregnant before starting therapy. If you are pregnant or suspect you may be
pregnant, ask your doctor or pharmacist for advice before using this medicine.

Breast-feeding
You should not breast-feed during treatment and for two weeks after treatment with Enrylaze,
as there may be a risk to the breast-fed baby.

Family planning
Both men and women must use a contraceptive measure and avoid conceiving a
child during treatment with Enrylaze and for 3 months after the last dose of Enrylaze. The use of
hormonal contraceptives is not recommended in women during treatment with Enrylaze.
Women should undergo pregnancy tests before starting treatment.

Driving and using machines
Enrylaze can cause nausea and headache that may affect your ability to drive and use
machines.

Enrylaze contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially
‘sodium-free’.

3. How to use Enrylaze

The doctor will determine which dose will be administered to you and whether it will be administered via infusion
into the veins or injection into the muscle. You may also be prescribed other medicines before you
start using Enrylaze, such as paracetamol and H1 and H2 receptor blockers.
The dose and the way it is administered may vary depending on your specific condition,
the area of the body surface and the response to therapy.
If Enrylaze is administered intravenously, it will be administered over 2 hours. If
Enrylaze is administered intramuscularly, different injection sites may be used.

If you use more Enrylaze than you should
If you have any doubts, contact your doctor or any other healthcare professional immediately.

If you forget to use Enrylaze
If you have any doubts, contact your doctor or any other healthcare professional immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported for patients treated with Enrylaze.

Serious side effects
Tell your doctor immediately if you experience:
Symptoms of a severe allergic reaction, including swelling of the face, wheezing, hay fever-like symptoms, skin
rash, chills, wheezing, flushing, vomiting, high or low blood pressure.
In the most severe cases, anaphylaxis may also occur (a sudden and severe allergic reaction
with difficulty breathing, swelling, mild confusion, rapid heartbeat,
sweating and loss of consciousness).
Symptoms of blood clots, even in the blood vessels of the lungs, which may appear as
sudden shortness of breath, chest pain or coughing up blood, and in the blood vessels of the brain,
which may appear with symptoms such as weakness/numbness, seizures, speech disturbances or
severe headache.
Symptoms of pancreatitis, including abdominal pain, nausea, vomiting, back pain or loss of appetite.

Other side effects
Talk to your doctor if you experience any of the following:
Very common side effects(may affect more than 1 in 10 people):

• allergic reaction, including skin rash, itching and hives
• infections
• low levels of red blood cells (anemia)
• low levels of platelets in the blood (thrombocytopenia)
• low levels of white blood cells (decreased white blood cell count)
• low levels of neutrophils, a type of white blood cell that fights infections (neutropenia)
• low levels of white blood cells (neutrophils) with fever due to infection (febrile neutropenia)
• low levels of lymphocytes, a type of white blood cell that fights infections (decreased lymphocyte count)
• stomach pain (abdominal pain)
• diarrhea
• feeling unwell (nausea)
• vomiting
• tiredness (fatigue)
• fever (pyrexia)
• high blood sugar levels (hyperglycemia)
• pain in the limbs (extremity pain)
• weight loss (decreased weight)
• headache
• decreased appetite
• abnormal liver function test (increased transaminases, increased blood bilirubin)
• reduction in albumin levels (a blood protein) (hypoalbuminemia)
• anxiety
• bruising (contusion)

Common side effects(may affect up to 1 in 10 people):

• blood poisoning (sepsis)
• sudden and severe allergic reaction with difficulty breathing, swelling, mild confusion, rapid heartbeat, sweating and loss of consciousness (anaphylactic reaction)
• skin rash characterized by flat, discolored patches (macules) and raised, red bumps (papules) (maculopapular rash)
• skin rash with redness and inflammation (erythematous rash)
• urticaria
• itchy skin (pruritus)
• inflammation of the pancreas (pancreatitis)
• pain at the injection site
• reaction at the injection site
• infusion-related reactions
• abnormal levels of blood clotting factors (prolonged activated partial thromboplastin time, decreased antithrombin III, decreased fibrinogen)
• abnormal kidney function (increased blood creatinine)
• low blood sugar levels (hypoglycemia)
• low blood pressure (hypotension)
• blood clots, even in the blood vessels of the lungs and brain
• irritability
• dizziness

Uncommon side effects(may affect up to 1 in 100)

• blood clot in one of the major veins of the brain (superior sagittal sinus thrombosis)
• blood clot in the neck vein (jugular vein thrombosis)
• blood clot in the veins of the limbs (deep vein thrombosis)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system
listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Enrylaze

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and vial after
Expiry/EXP. The expiry date refers to the last day of that month.
Store unopened vials in a refrigerator (2 °C – 8 °C) in an upright position. Do not freeze.
Keep the vial tightly closed to protect the medicine from light.
After preparing a dose in a syringe, Enrylaze can be stored for up to 8 hours at
room temperature (15 °C – 25 °C) or 24 hours in a refrigerator (2 °C – 8 °C).
After dilution in an intravenous bag, Enrylaze can be stored for up to 12 hours at
room temperature (15 °C – 25 °C) or 24 hours in a refrigerator (2 °C – 8 °C). The storage time
starts from the moment the solution has been taken from the unopened vials.
Do not use this medicine if you notice the presence of particles in the solution.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to dispose of medicines that
you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Enrylaze contains

• The active substance is recombinant chrysantaspase. Each vial contains 10 mg of recombinant chrysantaspase in 0.5 mL of solution.
• The other components are trehalose dihydrate, sodium chloride (see section 2 “Enrylaze contains sodium”), sodium hydroxide (for pH adjustment), disodium phosphate, sodium dihydrogen phosphate monohydrate, polysorbate 80 and water for injections.

Description of the appearance of Enrylaze and contents of the pack
Enrylaze is an injectable or infusion solution from clear to slightly yellow, free of
particulate matter.
One pack contains 3 glass vials, each with 0.5 mL of injectable or infusion
solution.

Marketing authorisation holder and manufacturer
Jazz Pharmaceuticals Ireland Ltd
5th Floor
Waterloo Exchange
Waterloo Road
Dublin 4
D04 E5W7
Ireland
Tel.: +353 1 968 1631
E-mail: [email protected]

Other sources of information
More detailed information on this medicine is available on the website of the European
Medicines Agency: http://www.ema.europa.eu . Furthermore, links to other websites on rare diseases
and related therapeutic treatments are provided.
This leaflet is available in all languages of the European Union/European Economic Area on the
website of the European Medicines Agency.