Erwinase 10 000 U powder for solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Crisantaspase

Available from:

Porton Biopharma Limited

ATC code:

L01XX02

INN (International Name):

Crisantaspase

Dosage:

10,000 unit(s)

Pharmaceutical form:

Powder for solution for injection/infusion

Therapeutic area:

asparaginase

Authorization status:

Marketed

Authorization date:

2021-06-18

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ERWINASE 10 000 U POWDER FOR SOLUTION FOR INJECTION/INFUSION.
Crisantaspase (L-asparaginase from _Erwinia chrysanthemi_)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, please talk to your doctor,
pharmacist or nurse.
-
If you get any of the side effects listed in section 4, or if you get
a side effect not listed in this
leaflet, please talk to your doctor, pharmacist or nurse.
WHAT IS IN THIS LEAFLET
1.
What Erwinase is and what it is used for.
2.
What you need to know before you receive Erwinase
3.
How to take this medicine.
4.
Possible side effects
5.
How to store this medicine.
6. Contents of the pack and other information
1.
WHAT ERWINASE IS AND WHAT IT IS USED FOR
HOW DOES ERWINASE WORK?
Erwinase is a treatment for blood-cell cancer and belongs to a group
of medicines known as
‘antineoplastic and immunomodulatory agents’. It works by reducing
the level of asparagine (an
amino acid) in your body. Asparagine is a substance that cancer cells
need in order to survive.
WHAT IS ERWINASE USED FOR?
This medicine is primarily used in children, for the treatment of
cancer of the white blood cells (Acute
Lymphoblastic Leukaemia), in patients who have had an allergic
reaction to other similar products.
This medicine is used alongside other treatments.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE ERWINASE
DO NOT USE ERWINASE IF:
•
You have previously had a severe allergic (hypersensitivity) reaction
to the active substance
(crisantaspase) or you are allergic to any of the other ingredients of
this medicine. You can find
these substances in Section 6.
•
You have severe liver function impairment.
•
You have or have previously had severe pancreas problems (acute
pancreatitis) caused by a
medicine that contains L-asparaginase.
•
You have inflammation of the pancreas (pancreatitis) that is not
connected to

Summary of Product characteristics

Health Products Regulatory Authority
31 May 2022
CRN00CN62
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Erwinase 10 000 U powder for solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 10 000 U crisantaspase (L-asparaginase from
_Erwinia chrysanthemi)._ For the full list of excipients, see section
6.1.
One unit of asparaginase activity is defined as the amount of enzyme
that catalyses the hydrolysis of one micromol of
L-asparagine per minute at pH 8.6 and 37 °C.
3 PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
White, lyophilised powder in a vial.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Erwinase is used in combination with other chemotherapeutic agents to
treat patients, principally children, with acute
lymphoblastic leukaemia who have developed hypersensitivity (clinical
allergy or silent inactivation) to _E. coli_ asparaginase or
pegylated asparaginase obtained from _E. coli_.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 25 000 U/m
2
IM or IV, three times weekly (Monday, Wednesday, Friday) for two
weeks, to replace
each dose of pegaspargase or each cycle of the treatment with
asparaginase.
The treatment can be further adapted according to the local protocol.
As wide differences in asparaginase activity have been seen in
children, it is possible that the optimal dose of crisantaspase
varies between patients. It is therefore recommended that the
asparaginase level be checked so that the dose can be
individually adapted.
_ _
_Paediatric patients _
The same dosage applies to children as to adults.
Method of administration
Erwinase solution can be administered intravenously or by
intramuscular injection.
For IV infusion, it is recommended that the reconstituted Erwinase
solution be further diluted in 100 ml of normal saline
solution and administered over 1 to 2 hours.
For instructions on the reconstitution and dilution of the medicinal
product before administration, see section 6.6.