Teriflunomide Sanofi

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Teriflunomide

Available from:

Sanofi-Aventis Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

Consumer Medicines Information 

Teriflunomide Sanofi– teriflunomide 14 mg tablets 

Property of the sanofi-aventis group  
Teriflunomide Sanofi-ccdsv0-cmiv1-26oct12 
Page 1 
TERIFLUNOMIDE 
SANOFI
®

_Teriflunomide _
CONSUMER MEDICINE 
INFORMATION 
WHAT IS IN THIS LEAFLET 
This leaflet answers some 
common questions about 
Teriflunomide 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 Teriflunomide 
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 
TERIFLUNOMIDE 
SANOFI IS USED 
FOR 

Teriflunomide Sanofi is 
used to treat relapsing forms 
of multiple sclerosis (MS). 
The cause of MS is not yet 
known.  MS affects the 
central nervous system 
(CNS)– the brain and spinal 
cord.  In MS, the body’s 
immune system reacts against 
its own myelin (the 
‘insulation’ or the protective 
sheath surrounding nerve 
fibres). With relapsing forms 
of MS, people can have 
repeated attacks or relapses of 
inflammation of the CNS from 
time to time. Symptoms vary 
from patient to patient and 
may include blurred vision, 
weakness in the legs or arms, 
or loss of control of bowel or 
bladder function).  These are 
followed by periods of 
recovery. 
Teriflunomide Sanofi works 
by selectively interfering with 
the ability of white blood cells 
(lymphocytes) to produce the 
disease response and nerve 
damage that ultimately leads 
to relapses. 
Teriflunomide Sanofi has been 
shown to reduce or decrease 
the number of relapses and 
slow down the progression of 
physical disa

Summary of Product characteristics

Product Information  
November 2012 
Teriflunomide Sanofi - teriflunomide 14 mg tablets 

Property of the sanofi-aventis group - strictly confidential 

sanofi-ccdsv0-piv1-26oct12.doc 
Page 1 
PRODUCT INFORMATION 
TERIFLUNOMIDE SANOFI 
NAME OF THE MEDICINE 
AUSTRALIAN APPROVED NAME 
Teriflunomide 
CHEMICAL STRUCTURE 
The chemical structure of teriflunomide is 
F
3
C
N
O
N
H
OH
CH
3

Molecular formula: C
12
H
9
F
3
N
2
O
2 
Molecular weight: 270.21 
Chemical name: (Z)-2-Cyano-3-hydroxy-but-2-enoic
acid-(4-trifluoromethylphenyl)-amide 
CAS REGISTRY NUMBER: 
163451-81-8

DESCRIPTION 
Teriflunomide, is an oral _de
novo_ pyrimidine synthesis inhibitor of the dihydroorotate 
dehydrogenase (DHO-DH) enzyme.  

Teriflunomide is a white to almost white powder that is
sparingly soluble in acetone, slightly 
soluble in polyethylene glycol and ethanol,
very slightly soluble in isopropanol and practically 
insoluble in water. Teriflunomide has a pKa of 3.1 at
room temperature and its aqueous solubility 
Product Information  
November 2012 
Teriflunomide Sanofi - teriflunomide 14 mg tablets 

Property of the sanofi-aventis group - strictly confidential 

sanofi-ccdsv0-piv1-26oct12.doc 
Page 2 
is pH dependent and decreases with lowering pH. Teriflunomide
is Class 2 in the 
Biopharmaceutics Classification System. 

Teriflunomide is formulated as film-coated tablets for
oral administration. Each tablet contains 14 
mg of teriflunomide and the
following inactive ingredients: lactose, maize starch, 
hydroxypropylcellulose, microcrystalline cellulose, sodium starch
glycollate, and magnesium 
stearate. The film coating (OPADRY complete
film coating system 03F20651 BLUE) is made of 
hypromellose, titanium dioxide, purified talc, macrogol 8000 and
indigo carmine aluminium lake. 
PHARMACOLOGY 
PHARMACODYNAMICS 
MECHANISM OF ACTION 
Teriflun