ONCASPAR pegaspargase 3750 units/5mL injection solution vial

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

pegaspargase

Tilgjengelig fra:

Servier Laboratories Australia Pty Ltd

Autorisasjon status:

Registered

Informasjon til brukeren

ONCASPAR CMI MAR 2019
1
ONCASPAR
®
_Pegaspargase injection _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ONCASPAR. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking ONCASPAR
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
PLEASE READ THIS LEAFLET CAREFULLY
AND KEEP IT FOR FUTURE REFERENCE.
Please also note that this leaflet is
subject to change, therefore, ask your
doctor whether this is the latest
information regarding this medicine.
WHAT ONCASPAR
USED FOR
ONCASPAR contains pegaspargase
which is a form of an enzyme called
asparaginase. This enzyme breaks
down to asparaginase, an important
building block in making proteins,
without which cells cannot survive.
ONCASPAR lowers asparaginase
levels in blood cancer cells and stops
the cancer from growing.
Pegaspargase may sometimes be
called pegylated (or "PEG")
asparaginase.
ONCASPAR is used to treat
leukaemia. It belongs to a group of
medicines called antineoplastic or
cytotoxic medicines. You may also
hear of these being called
chemotherapy medicines.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
There is no evidence that it is
addictive.
This medicine is available only with
a doctor's prescription.
BEFORE BEING TREATED
WITH ONCASPAR
_WHEN YOU MUST NOT TAKE IT _
ONCASPAR MUST NOT BE GIVEN IF
YOU:
•
Are allergic to pegaspargase or
any of the ingredients listed at the
end of this leaflet
•
If you have ever had blood clots
following asparaginase therapy
•
If you have ever had pancreatitis
(inflammation of the pancreas)
•
If you have ever had severe
bleeding following asparaginase
therapy.
TELL YOUR DOCTOR IF YOU ARE
PREGNANT OF PLAN TO BECOME
PREGNANT.
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AUSTRALIAN PRODUCT INFORMATION
ONCASPAR
® (PEGASPARGASE)
Version: 6
1/19
AUSTRALIAN PRODUCT INFORMATION
ONCASPAR
® (PEGASPARGASE)
1
NAME OF THE MEDICINE
Pegaspargase.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ONCASPAR (pegaspargase) is a modified version of the enzyme
asparaginase. Pegaspargase,
the active substance, is a covalent conjugate of Escherichia coli (E.
coli) derived asparaginase with
monomethoxypolyethylene glycol (mPEG) using a succinimidyl-succinate
linker.
L-asparaginase is a tetrameric enzyme that is produced endogenously by
E. coli and consists of
identical 34.5 kDa subunits. Approximately 69 to 82 molecules of mPEG
are linked to L-
asparaginase; the molecular weight of each mPEG molecule is about 5
kDa. ONCASPAR activity
is expressed in Units. One unit is defined as the quantity of enzyme
required to liberate 1 µmol
ammonia per minute at pH 7.3 and 37
⁰
C. One vial of 5 mL solution contains 3,750 U.
The potency of this product should not be compared to any other
pegylated or non-pegylated
protein of the same therapeutic class.
For the full list of excipients, see section 6.1_ - List of
excipients_.
3
PHARMACEUTICAL FORM
Injection, solution.
APPEARANCE
Clear, colourless solution for injection in a Type I glass vial closed
with a grey rubber stopper and
an aluminium seal with flip-off cap.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ONCASPAR is indicated as a component of antineoplastic combination
therapy in patients with
Acute Lymphoblastic Leukaemia (ALL).
4.2
D
OSE AND METHOD OF ADMINISTRATION
Treatment should be prescribed by physicians and administered by
health care personnel
experienced in the use of antineoplastic products. The product should
only be given in a clinical
setting where appropriate resuscitation equipment is available.
Patients should be closely
monitored and carefully observed for any adverse reactions throughout
the administration period
(see also section 4.4_ - Special warnings and precautions for use_).
As a routine precautionary
measure patients should be