BYETTA 10 exenatide 10 micrograms/40 microlitres (2.4mL in total) solution for injection multidose cartridge

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

exenatide, Quantity: 250 microgram/mL

Available from:

AstraZeneca Pty Ltd

INN (International Name):

Exenatide

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium acetate; water for injections; metacresol; glacial acetic acid; mannitol

Administration route:

Subcutaneous

Units in package:

1 pre-filled pen (2.4 mL)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Exenatide is indicated as adjunctive therapy to improve glycaemic control in patients with type 2 diabetes mellitus who are taking metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea, or a combination of metformin and a basal insulin, but are not achieving adequate glycaemic control.

Product summary:

Visual Identification: Clear, colourless liquid.; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2007-06-28

Patient Information leaflet

BYETTA
®
_Exenatide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about BYETTA.
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 BYETTA
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 BYETTA IS USED
FOR
BYETTA is an injectable medicine
used to improve blood sugar control
in adults with type 2 diabetes
mellitus. It is used with metformin or
a sulfonylurea. It may also be used
with a combination of both
metformin and a sulfonylurea. Your
medicine can also be used in
combination with a long acting
insulin and metformin.
Diabetes mellitus is a condition in
which your pancreas does not
produce enough insulin to control
your blood sugar level. BYETTA
helps your body to increase
production of insulin when your
blood sugar is high.
BYETTA 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
BYETTA
_WHEN YOU MUST NOT USE IT_
DO NOT USE BYETTA IF:
•
you have type 1 diabetes or
diabetic ketoacidosis (often
caused by very high blood
glucose levels)
•
you are allergic to exenatide or
meta-Cresol or any of the
ingredients listed at the end of
this leaflet
•
you have severe kidney problems
or you are on dialysis
DO NOT USE THE BYETTA PEN

Summary of Product characteristics

BYETTA
®
Product Information
Doc ID-002465160 V8.0
1(25)
AUSTRALIAN PRODUCT INFORMATION
BYETTA
® (EXENATIDE) SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINE
Exenatide.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
BYETTA 5 MICROGRAMS SOLUTION FOR INJECTION
BYETTA 5 µg pre-filled pen contains 60 doses of sterile, preserved
isotonic solution
(approximately 1.2 mL). Each dose contains 5 µg exenatide in 20
microlitres
(0.25 mg synthetic exenatide per mL).
BYETTA 10 MICROGRAMS SOLUTION FOR INJECTION
BYETTA 10 µg pre-filled pen contains 60 doses of sterile, preserved
isotonic solution
(approximately 2.4 mL). Each dose contains 10 µg exenatide in 40
microlitres
(0.25 mg synthetic exenatide per mL).
Each millilitre of BYETTA contains 250 µg of synthetic exenatide.
For a full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Solution for injection. BYETTA is a clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Exenatide is indicated as adjunctive therapy to improve glycaemic
control in patients
with type 2 diabetes mellitus who are taking metformin, a
sulfonylurea, or a
combination of metformin and a sulfonylurea, or a combination of
metformin and a
basal insulin, but are not achieving adequate glycaemic control.
4.2
DOSE AND METHOD OF ADMINISTRATION
Exenatide therapy should be initiated at 5 μg exenatide per dose
administered twice
daily (BID) for at least one month in order to improve tolerability.
The dose of
BYETTA can then be increased to 10 μg BID to further improve
glycaemic control.
Doses higher than 10 µg BID are not recommended.
Exenatide can be administered at any time within the 60-minute period
before the
morning and evening meals (or before the two main meals of the day,
approximately
6 hours or more apart). Exenatide should not be administered after a
meal. If an
injection is missed, the treatment should be continued with the next
scheduled dose.
BYETTA
®
Product Information
Doc ID-002465160 V8.0
2(25)
Each dose of BYETTA should be administere