ONCASPAR pegaspargase 3750 units/5mL powder for solution injection/infusion vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pegaspargase, Quantity: 750 U/mL

Available from:

Servier Laboratories (Aust) Pty Ltd

Pharmaceutical form:

Solution, powder for

Composition:

Excipient Ingredients: sucrose; dibasic sodium phosphate; monobasic sodium phosphate; sodium chloride; sodium hydroxide; hydrochloric acid

Administration route:

Intravenous Infusion, Intramuscular

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ONCASPAR is indicated as a component of antineoplastic combination therapy in patients with Acute Lymphoblastic Leukaemia (ALL).

Product summary:

Visual Identification: Oncaspar is a white to off white powder. After reconstitution, the solution is clear, colourless and free from visible foreign particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2019-03-08

Patient Information leaflet

ONCASPAR
®
_Pegaspargase powder for solution for injection/infusion_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ONCASPAR.
It does not contain all of the available
information. All medicines have risks
and benefits. Your doctor has
weighed the risks of using your
medicine against the benefit that it
will have for you.
It does not take the place of talking to
your doctor or pharmacist.
IF YOU HAVE ANY CONCERNS ABOUT
HAVING 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 IS ONCASPAR
ONCASPAR contains pegaspargase
which is a form of an enzyme called
asparaginase. This enzyme breaks
down asparagine, an important
building block in making proteins,
without which cells cannot survive.
Normal cells can make asparagine
for themselves, while some cancer
cells cannot. ONCASPAR lowers
asparagine levels in blood cancer
cells and stops the cancer growing.
Pegaspargase may sometimes be
called pegylated (or "PEG")
asparaginase.
WHAT ONCASPAR IS
USED FOR
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
ONCASPAR MUST NOT BE GIVEN IF
YOU:
•
are allergic to pegaspargase or
any of the ingredients listed at the
end of this leaflet
•
have severe hepatic (liver)
disease.
•
have ever had pancreatitis
(inflammation of the pancreas)
•
have ever had blood clots
following asparaginase therapy
•
have ever had severe bleeding
following aspara

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION - ONCASPAR
® (PEGASPARGASE, LYOPHILISED)
Version 5
1/20
AUSTRALIAN PRODUCT INFORMATION
ONCASPAR
® (PEGASPARGASE) POWDER FOR SOLUTION FOR INJECTION/INFUSION
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 °C.
Each vial contains 3,750 U pegaspargase. After reconstitution, 1 mL of
solution contains 750 U
pegaspargase (750 U/mL). 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
Powder for solution for injection/infusion.
APPEARANCE
Lyophilised white to off-white powder. After reconstitution, the
solution is clear, colourless and free
from visible particles. 1 mL of solution contains 750 U pegaspargase.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
ONCASPAR is indicated as a component of antineoplastic combination
therapy in patients with
Acute Lymphoblastic Leukaemia (ALL).
4.2
DOSE
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