Oncaspar

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Pegaspargase 3750 U (4050U including overage)

Available from:

Servier Laboratories NZ Ltd

Dosage:

3750 U/5mL

Pharmaceutical form:

Powder for injection

Composition:

Active: Pegaspargase 3750 U (4050U including overage) Excipient: Dibasic sodium phosphate Hydrochloric acid Monobasic sodium phosphate Sodium chloride Sodium hydroxide Sucrose

Prescription type:

Prescription

Therapeutic indications:

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

Product summary:

Package - Contents - Shelf Life: Vial, single dose, - 3750 U - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) 6 hours reconstituted (not refrigerated) stored at or below 25°C 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze). following reconstitution 6 hours diluted stored at or below 25°C. following reconstitution

Authorization date:

2020-06-01

Patient Information leaflet

ONCASPAR®
1
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
fo

Summary of Product characteristics

NEW ZEALAND DATA SHEET
ONCASPAR
®
Datasheet 25 August 2022
1/20
1
ONCASPAR
® (PEGASPARGASE) 750 U/ML POWDER FOR SOLUTION FOR
INJECTION/INFUSION
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 observed for any
adverse reactions throughout the administration period (see