LIXISENATIDE SANOFI TREATMENT INITIATION PACK 10mcg (0.05 mg/mL) and 20 mcg (0.1) mg/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

Authorization status:

Registered

Patient Information leaflet

Property of the Sanofi group
Lixisenatide-sanofi-ccdsv5-cmiv2-14feb17
Page 1
LIXISENATIDE
SANOFI
®
_lixisenatide _
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Lixisenatide
Sanofi.
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
Sanofi 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
SANOFI IS USED FOR
Lixisenatide Sanofi contains the
active substance lixisenatide.
Lixisenatide Sanofi is a medicine
used to control the blood sugar
level when it is too high in adult
patients with type 2 diabetes
mellitus.
Lixisenatide Sanofi 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
Sanofi.
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
Sanofi helps to control your blood
sugar levels only when it is too high.
Lixisenatide Sanofi 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 Sanofi 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 SANOFI
WHEN YOU MUST NOT USE IT

Summary of Product characteristics

PRODUCT INFORMATION
December 2015
LYXUMIA - lixisenatide
PRODUCT INFORMATION
LIXISENATIDE SANOFI 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-sanofi-ccdsv5-piv5-14feb17
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PRODUCT INFORMATION
December 2015
LYXUMIA - lixisenatide
DESCRIPTION
Lixisenatide is an amorphous, hygroscopic, white to off-white powder.
Lixisenatide Sanofi solution is a clear, colourless solution.
Lixisenatide Sanofi 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 Sanofi 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
showed
a
tr