LIXISENATIDE SANOFI

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Lixisenatide

Available from:

Sanofi-Aventis Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

Property of the sanofi-aventis group  
lixi-ccdsv1-cmiv1-d4-27feb13 
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 

Summary of Product characteristics

PRODUCT INFORMATION  

Lixisenatide Sanofi 

Property of the sanofi-aventis group 
lixisenatide-ccdsv1.0-piv1-d13-15mar13 
- 1 - 
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 
PRODUCT INFORMATION  

Lixisenatide Sanofi 

Property of the sanofi-aventis group 
lixisenatide-ccdsv1.0-piv1-d13-15mar13 
- 2 - 
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).
Lixise