Byetta

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

Exenatide

Saatavilla:

Bristol-Myers Squibb Australia Pty Ltd

luokka:

Medicine Registered

Pakkausseloste

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 U

Valmisteyhteenveto

BYETTA
®
 Product Information 
CV.000-758-474.3.0 
1(24) 
BYETTA
®

exenatide 
PRODUCT INFORMATION 
NAME OF THE MEDICINE 
BYETTA (exenatide) injection, solution. 
The active ingredient in BYETTA is
exenatide.  Exenatide is a 39-amino acid 
peptide amide. It has the empirical formula C
184
H
282
N
50
O
60
S and molecular weight 
of 4186.6 Daltons. The amino acid sequence for exenatide is
shown below. 
H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-
Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-
Pro-Ser-NH
2
. 
The CAS number for exenatide is 141732-76-5. 
DESCRIPTION 
BYETTA is a clear colourless solution. 
BYETTA is supplied as a sterile, preserved solution for
subcutaneous injection in a 
glass cartridge that has been assembled in an injector
pen. Each millilitre contains 
250 µg of synthetic exenatide. The excipients
in BYETTA are meta-Cresol, 
mannitol, acetic acid-glacial, sodium acetate, and water for
injections. 
PHARMACOLOGY 
MECHANISM OF ACTION 
Exenatide is a glucagon-like peptide-1 (GLP-1) receptor
agonist that exhibits 
several antihyperglycaemic
actions of glucagon-like peptide-1 (GLP-1). The amino 
acid sequence of exenatide partially overlaps
that of human GLP-1. Exenatide has 
been shown to bind to and activate the known human GLP-1 receptor _in vitro_. This 
leads
to an increase in both the glucose-dependent insulin synthesis and secretion 
from pancreatic beta-cells, by mechanisms involving cyclic
AMP and/or other 
intracellular signalling pathways. As
blood glucose concentrations decrease, 
insulin secretion subsides thereby reducing the potential risk
of hypoglycaemia 
(see PRECAUTIONS). 
Exenatide suppresses glucagon secretion which is
known to be inappropriately 
elevated in type 2 diabetes. Lower glucagon concentrations
lead to decreased 
hepatic gluc