BYDUREON exenatide 2 mg powder for injection pre-filled pen

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

exenatide, Quantity: 2 mg

Available from:

AstraZeneca Pty Ltd

INN (International Name):

Exenatide

Pharmaceutical form:

Injection, modified release

Composition:

Excipient Ingredients: sucrose; polyglactin

Administration route:

Subcutaneous

Units in package:

1 pen sample pack, 4 pens

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Exenatide is indicated for the treatment of type 2 diabetes mellitus to improve glycaemic control in combination with other glucose-lowering medicinal products when the therapy in use, together with diet and exercise, does not provide adequate glycaemic control (see Section 5.1 PHARMACODYNAMIC PROPERTIES - Clinical trials for available data on different combinations).

Product summary:

Visual Identification: White to off white powder; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2015-06-25

Patient Information leaflet

BYDUREON
®
_exenatide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about BYDUREON.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date shown on the
final page. More recent information
on this medicine may be available.
Make sure you speak to your
pharmacist, nurse or doctor to obtain
the most up to date information on
this medicine.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking BYDUREON
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, CONSULT YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT BYDUREON IS
USED FOR
BYDUREON is an injectable
medicine used to improve blood
sugar control in adults with type 2
diabetes mellitus.
BYDUREON is used with other
medicines for type 2 diabetes
mellitus when they are not enough to
control your blood sugar level, along
with diet and exercise.
ASK YOUR DOCTOR OR HEALTHCARE
PROFESSIONAL IF YOU ARE NOT SURE
WHETHER YOUR ANTIDIABETIC
MEDICINE CONTAINS SULFONYLUREA.
Diabetes mellitus is a condition in
which your pancreas does not
produce enough insulin to control
your blood sugar level. BYDUREON
helps your body to increase
production of insulin when your
blood sugar is high.
BYDUREON is not a substitute for
insulin in patients who require
insulin treatments for their diabetes.
This medicine has not been studied in
children.
This medicine is only available with
a doctor's prescription.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
BEFORE YOU USE
BYDUREON
_WHEN YOU MUST NOT USE IT_
DO NOT USE BYDUREON IF:
•
you have type 1 diabetes or
diabetic ketoacidosis (often
caused by very high blood
glucose levels)
•
you are allergic to exenatide or
any of the ingredients listed at the
end of this leaflet
•
you have s

Summary of Product characteristics

BYDUREON
®
Product Information
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1(43)
AUSTRALIAN PRODUCT INFORMATION
BYDUREON
® (EXENATIDE)
1.
NAME OF THE MEDICINE
Exenatide.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
BYDUREON BCISE SUSPENSION FOR INJECTION IN AUTOINJECTOR (BYDUREON
BCISE
AUTOINJECTOR)
Each autoinjector delivers a dose of 2 mg of exenatide in 0.85 mL.
BYDUREON POWDER FOR INJECTION IN PRE-FILLED PEN (BYDUREON PEN)
Each pre-filled pen contains 2 mg of exenatide. After suspension, each
pen delivers
a dose of 2 mg in 0.65 mL.
BYDUREON POWDER FOR INJECTION IN VIAL WITH DILUENT SYRINGE (BYDUREON
KIT)
Each vial contains 2 mg of exenatide. After suspension, a dose of 2 mg
in 0.65 mL is
delivered.
BYDUREON is an extended release microspheres formulation of exenatide.
When
the product is prepared as instructed, the resulting suspension
contains 2 mg
exenatide. The suspension is intended for subcutaneous use only, once
per week.
For a full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
BYDUREON is supplied in the following presentations:
BYDUREON BCISE AUTOINJECTOR
Extended-release suspension for injection.
White to off-white opaque suspension.
BYDUREON PEN
Powder and diluent for extended-release suspension for injection.
_Powder_: White to off-white powder.
_Diluent_: Clear, colourless to pale yellow to pale brown solution.
BYDUREON KIT
Powder and diluent for extended-release suspension for injection.
BYDUREON
®
Product Information
Doc ID-002466034 V13.0
2(43)
_Powder_: White to off-white powder.
_Diluent_: Clear, colourless to pale yellow to pale brown solution.
Exenatide is also available in an immediate-release formulation
(BYETTA). For
information related to this formulation, please refer to the BYETTA
Product
Information.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BYDUREON is indicated for the treatment of type 2 diabetes mellitus to
improve
glycaemic control in combination with other glucose-lowering medicinal
products
when the therapy in use, together with diet and exercise, does