ONCASPAR 750 UML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PEGASPARGASE

Available from:

TZAMAL BIO-PHARMA LTD

ATC code:

L01XX24

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJ/INF

Composition:

PEGASPARGASE 3750 U/VIAL

Administration route:

I.M, I.V

Prescription type:

Required

Manufactured by:

LES LABORATOIRES SERVIER, FRANCE

Therapeutic area:

PEGASPARGASE

Therapeutic indications:

Oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years, and adult patients.

Authorization date:

2020-08-25

Summary of Product characteristics

1
PRESCRINING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Oncaspar 750 U/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 3,750 Units (U)** of pegaspargase*.
After reconstitution, 1 ml of solution contains 750 U pegaspargase
(750 U/ml).
* The active substance is a covalent conjugate of
_Escherichia coli_
-derived L-asparaginase with
monomethoxypolyethylene glycol
**One unit is defined as the quantity of enzyme required to liberate 1
µmol ammonia per minute at
pH 7.3 and 37°C
The potency of this medicinal product should not be compared to the
one of another pegylated or
non-pegylated protein of the same therapeutic class. For more
information, see section 5.1.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
White to off-white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oncaspar is indicated as a component of antineoplastic combination
therapy in acute lymphoblastic
leukaemia (ALL) in paediatric patients from birth to 18 years, and
adult patients.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Oncaspar should be prescribed and administered by physicians and/or
health care personnel
experienced in the use of antineoplastic products. It should only be
given in a hospital setting where
appropriate resuscitation equipment is available. Patients should be
closely monitored for any adverse
reactions throughout the administration period (see section 4.4).
Posology
Oncaspar is usually administered as part of combination chemotherapy
protocols with other
antineoplastic agents (see also section 4.5).
_Paediatric patients and adults ≤21 years _
The recommended dose in patients with a body surface area (BSA) ≥0.6
m
2
and who are ≤21 years of
age is 2,500 U of pegaspargase (equivalent to 3.3 ml Oncaspar)/m
2
body surface area every 14 days.
Children with a body surface area <0.6 m
2
should receive 82.5 U of pegaspargase (equivalent to 0.1 ml
Oncaspar)/kg body weight every 14 days.
_ _
2
_Adults >21 years _
Unless otherwise