LIXISENATIDE WINTHROP lixisenatide 10 mcg (0.05mg/mL) solution for injection injector pen

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Lixisenatide

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Lixisenatide

Patient Information leaflet

Property of the sanofi-aventis group
lixi-ccdsv1-cmiv1-d4-27feb13
Page 1
LIXISENATIDE
WINTHROP
®
_lixisenatide _
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Lixisenatide
Winthrop.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Lixisenatide
Winthrop against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT LIXISENATIDE
WINTHROP IS USED FOR
Lixisenatide Winthrop contains the
active substance lixisenatide.
Lixisenatide Winthrop is a
medicine used to control the blood
sugar level when it is too high in
adult patients with type 2 diabetes
mellitus.
Lixisenatide Winthrop is used with
other antidiabetic medicines for
diabetes when they are not enough
to control your blood sugar levels.
Your doctor will prescribe the best
combination to manage your type 2
diabetes mellitus.
It is also important to control your diet
and exercise while using Lixisenatide
Winthrop.
CHECK WITH YOUR DOCTOR OR
HEALTHCARE PROFESSIONAL IF YOU ARE
NOT SURE WHETHER YOUR ANTIDIABETIC
MEDICINES CONTAIN A SULFONYLUREA OR
BASAL INSULIN.
Diabetes mellitus is a condition in
which your pancreas does not produce
enough insulin to control your blood
sugar (glucose) level. Lixisenatide
Winthrop helps to control your blood
sugar levels only when it is too high.
Lixisenatide Winthrop is not a
substitute for insulin in patients who
require insulin treatments for their
diabetes. In some cases it may be used
as well as insulin.
Your doctor, however, may have
prescribed Lixisenatide Winthrop for
another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available with a
doctor's prescription.
BEFORE YOU USE
LIXISENATIDE WINTHROP
WHEN

Summary of Product characteristics

PRODUCT INFORMATION
December 2015
LYXUMIA - lixisenatide
PRODUCT INFORMATION
LIXISENATIDE WINTHROP INJECTION, SOLUTION
NAME OF MEDICINE
AUSTRALIAN APPROVED NAME
Lixisenatide
CHEMICAL STRUCTURE
The structure of lixisenatide is a peptide containing 44 amino acids,
which is amidated at the C-
terminal amino acid (position 44). The order of the amino acids is
given in the figure below. Its
molecular weight is 4858.5, and the empirical formula is C
215
H
347
N
61
O
65
S with the following
chemical structure:
MOLECULAR WEIGHT
4858.5
CAS REGISTRY NUMBER
320367-13-3
Property of the sanofi-aventis group
lixisenatide-winthrop-ccdsv5-piv5-14feb17
- 1 -
PRODUCT INFORMATION
December 2015
LYXUMIA - lixisenatide
DESCRIPTION
Lixisenatide is an amorphous, hygroscopic, white to off-white powder.
Lixisenatide Winthrop solution is a clear, colourless solution.
Lixisenatide Winthrop is supplied as a sterile solution for
subcutaneous injection in a 3mL glass
cartridge that has been permanently integrated into a pre-filled
injector pen.
Lixisenatide Winthrop is available as 2 different pens which deliver
either a 10μg or 20μg dose of
lixisenatide. Each dose also contains glycerol (85%), sodium acetate,
methionine, meta-cresol,
hydrochloric acid/sodium hydroxide for pH adjustment, and water for
injections.
PHARMACOLOGY
PHARMACODYNAMICS
MECHANISM OF ACTION
Lixisenatide is a potent and selective GLP-1 receptor agonist (Ki =
1.33nM in radioligand binding
experiments). The GLP-1 receptor is the target for native GLP-1, an
endogenous incretin hormone
that potentiates glucose-dependent insulin secretion from the
pancreatic beta cells.
Lixisenatide action is mediated via a specific interaction with GLP-1
receptors, leading to an
increase in intracellular cyclic adenosine monophosphate (cAMP).
Lixisenatide stimulates insulin
secretion when blood glucose is increased but not at normoglycaemia.
In parallel, glucagon
secretion is suppressed. In case of hypoglycaemia, the rescue
mechanism of glucagon secretion is
preserved.
Lixisenatide
further
s