Aubagio
1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 
 
 
 
 
 



 

2 

1. NAME OF THE MEDICINAL PRODUCT 
 
AUBAGIO 14 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each film-coated tablet contains 14 mg of teriflunomide. 
 
Excipient with known effect: each tablet contains 72 mg of lactose (as monohydrate).  
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet (tablet). 
 
Pale blue to pastel blue, pentagonal film-coated tablets with imprint on one side (‘14’) and engraved with a 
corporate logo on the other side. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
AUBAGIO is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (MS) 
(please refer to section 5.1 for important information on the population for which efficacy has been 
established). 
 
4.2 Posology and method of administration 
 
The treatment should be initiated and supervised by a physician experienced in the management of multiple 
sclerosis. 
 
Posology 
 
The recommended dose of teriflunomide is 14 mg once daily.  
 
Special populations 
 
Elderly population 
AUBAGIO should be used with caution in patients aged 65 years and over due to insufficient data on safety 
and efficacy. 
 
Renal impairment 
No dosage adjustment is necessary for patients with mild, moderate or severe renal impairment not 
undergoing dialysis. 
Patients with severe renal impairment undergoing dialysis were not evaluated. Teriflunomide is 
contraindicated in this population (see section 4.3). 
 
Hepatic impairment 
No dosage adjustment is necessary for patients with mild and moderate hepatic impairment. Teriflunomide is 
contraindicated in patients with severe hepatic impairment (see section 4.3). 
 
Paediatric population 



 

3 

The safety and efficacy of teriflunomide in children aged from 10 to less than 18 years has not yet been 
established. There is no relevant use of teriflunomide in children aged from birth to less than 10 years for the 
treatment of multiple sclerosis. 
No data are available. 
 
Method of administration 
 
The film-coated tablets are for oral use. The tablets should be swallowed whole with some water. AUBAGIO 
can be taken with or without food. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
Patients with severe hepatic impairment (Child-Pugh class C). 
 
Pregnant women, or women of childbearing potential who are not using reliable contraception during 
treatment with teriflunomide and thereafter as long as its plasma levels are above 0.02 mg/l (see section 4.6). 
Pregnancy must be excluded before start of treatment (see section 4.6). 
 
Breast-feeding women (see section 4.6). 
 
Patients with severe immunodeficiency states, e.g. acquired immunodeficiency syndrome (AIDS). 
 
Patients with significantly impaired bone marrow function or significant anaemia, leucopenia, neutropenia or 
thrombocytopenia. 
 
Patients with severe active infection until resolution (see section 4.4). 
 
Patients with severe renal impairment undergoing dialysis, because insufficient clinical experience is 
available in this patient group. 
 
Patients with severe hypoproteinaemia, e.g. in nephrotic syndrome. 
 
4.4 Special warnings and precautions for use 
 
Monitoring 
 
Before treatment 
Before starting treatment with teriflunomide the following should be assessed:  
 Blood pressure 
 Alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT) 
 Complete blood cell count including differential white blood cell and platelet count. 
 
During treatment 
During treatment with teriflunomide the following should be monitored:  
 Blood pressure 

o Check periodically 
 Alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT) 

o Liver enzymes should be assessed every two weeks during the first 6 months of treatment, 
and every 8 weeks thereafter or as indicated by clinical signs and symptoms such as 
unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark 
urine. For ALT (SGPT) elevations between 2- and 3-fold the upper limit of normal, 
monitoring must be performed weekly. 

 Complete blood cell counts should be performed based on clinical signs and symptoms (e.g. 
infections) during treatment. 

 



 

4 

Accelerated elimination procedure 
 
Teriflunomide is eliminated slowly from the plasma. Without an accelerated elimination procedure, it takes 
an average of 8 months to reach plasma concentrations less than 0.02 mg/l, although due to individual 
variation in substance clearance it may take up to 2 years. An accelerated elimination procedure can be used 
at any time after discontinuation of teriflunomide (see sections 4.6 and 5.2 for procedural details). 
 
Hepatic effects 
 
Elevations of liver enzymes have been observed in patients receiving teriflunomide (see section 4.8). These 
elevations occurred mostly within the first 6 months of treatment. 
Teriflunomide therapy should be discontinued if liver injury is suspected; consider discontinuing 
teriflunomide therapy if elevated liver enzymes (greater than 3-fold ULN) are confirmed.  
 
Patients with pre-existing liver disease and/or who consume substantial quantities of alcohol may be at 
increased risk of developing elevated liver enzymes when taking teriflunomide and should be closely 
monitored for signals of liver disease.  
 
Hypoproteinaemia 
 
Since teriflunomide is highly protein bound and as the binding is dependent upon the concentrations of 
albumin, unbound plasma teriflunomide concentrations are expected to be increased in patients with 
hypoproteinaemia, e.g. in nephrotic syndrome. Teriflunomide should not be used in patients with conditions 
of severe hypoproteinaemia. 
 
Blood pressure  
 
Elevation of blood pressure may occur during treatment with teriflunomide (see section 4.8). Blood pressure 
must be checked before the start of teriflunomide treatment and periodically thereafter. Blood pressure 
elevation should be appropriately managed before and during treatment with teriflunomide. 
 
Infections 
 
Initiation of treatment with teriflunomide should be delayed in patients with severe active infection until 
resolution.  
In placebo-controlled studies, no increase in serious infections was observed with teriflunomide (see section 
4.8). However, based on the immunomodulatory effect of teriflunomide, if a patient develops a serious 
infection, suspending treatment with AUBAGIO should be considered and the benefits and risks should be 
reassessed prior to re-initiation of therapy. Due to the prolonged half-life, accelerated elimination with 
cholestyramine or charcoal may be considered. 
Patients receiving AUBAGIO should be instructed to report symptoms of infections to a physician. Patients 
with active acute or chronic infections should not start treatment with AUBAGIO until the infection(s) is 
resolved.  
The safety of teriflunomide in individuals with latent tuberculosis infection is unknown, as tuberculosis 
screening was not systematically performed in clinical studies. For patients testing positive in tuberculosis 
screening, treat by standard medical practice prior to therapy with AUBAGIO. 
 
Respiratory reactions 
 
Interstitial lung disease (ILD) has been reported with teriflunomide in the postmarketing setting.  
ILD and worsening of pre-existing ILD have been reported during treatment with leflunomide, the parent 
compound of teriflunomide. The risk is increased in patients who had a history of ILD when treated with 
leflunomide.  
 
ILD may occur acutely at any time during therapy with a variable clinical presentation.  
ILD may be fatal. New onset or worsening pulmonary symptoms, such as persistent cough and dyspnoea, 
may be a reason for discontinuation of the therapy and for further investigation, as appropriate. If 



 

5 

discontinuation of the medicinal product is necessary, initiation of an accelerated elimination procedure 
should be considered. 
 
Haematological effects 
 
A mean decrease less than 15% from baseline affecting white blood cell count has been observed (see 
section 4.8). As a precaution, a recent complete blood cell count, including differential white blood cell 
count and platelets, should be available before the initiation of treatment with AUBAGIO and the complete 
blood cell count should be assessed during AUBAGIO therapy as indicated by clinical signs and symptoms 
(e.g., infections). 
 
In patients with pre-existing anaemia, leucopenia, and /or thrombocytopenia as well as in patients with 
impaired bone marrow function or those at risk of bone marrow suppression, the risk of haematological 
disorders is increased. If such effects occur, the accelerated elimination procedure (see above) to reduce 
plasma levels of teriflunomide should be considered. 
In cases of severe haematological reactions, including pancytopenia, AUBAGIO and any concomitant 
myelosuppressive treatment must be discontinued and a teriflunomide accelerated elimination procedure 
should be considered. 
 
Skin reactions 
 
Cases of severe skin reactions have been reported postmarketing (including Stevens-Johnson syndrome and 
toxic epidermal necrolysis). 
 
In patients treated with leflunomide, the parent compound, very rare cases of Drug Reaction with 
Eosinophilia and Systemic Symptoms (DRESS) have also been reported.  
 
In case of ulcerative stomatitis, teriflunomide administration should be discontinued. If skin and /or mucosal 
reactions are observed which raise the suspicion of severe generalised major skin reactions (Stevens-Johnson 
syndrome, or toxic epidermal necrolysis-Lyell’s syndrome), teriflunomide and any other possibly associated 
treatment must be discontinued, and an accelerated procedure initiated immediately. In such cases patients 
should not be re-exposed to teriflunomide (see section 4.3). 
 
New onset of psoriasis (including pustular psoriasis) and worsening of pre-existing psoriasis have been 
reported during the use of teriflunomide. Treatment withdrawal and initiation of an accelerated elimination 
procedure may be considered taking into account patient’s disease and medical history. 
 
Peripheral neuropathy 
 
Cases of peripheral neuropathy have been reported in patients receiving AUBAGIO (see section 4.8). Most 
patients improved after discontinuation of AUBAGIO. However, there was a wide variability in final 
outcome, i.e. in some patients the neuropathy resolved and some patients had persistent symptoms. If a 
patient taking AUBAGIO develops a confirmed peripheral neuropathy, consider discontinuing AUBAGIO 
therapy and performing the accelerated elimination procedure. 
 
Vaccination 
 
Two clinical studies have shown that vaccinations to inactivated neoantigen (first vaccination), or recall 
antigen (reexposure) were safe and effective during AUBAGIO treatment. The use of live attenuated 
vaccines may carry a risk of infections and should therefore be avoided. 
 



 

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Immunosuppressive or immunomodulating therapies 
 
As leflunomide is the parent compound of teriflunomide, co-administration of teriflunomide with 
leflunomide is not recommended.  
Co-administration with antineoplastic or immunosuppressive therapies used for treatment of MS has not 
been evaluated. Safety studies, in which teriflunomide was concomitantly administered with interferon beta 
or with glatiramer acetate for up to one year did not reveal any specific safety concerns, but a higher adverse 
reaction rate as compared to teriflunomide monotherapy was observed. The long term safety of these 
combinations in the treatment of multiple sclerosis has not been established. 
 
Switching to or from AUBAGIO 
 
Based on the clinical data related to concomitant administration of teriflunomide with interferon beta or with 
glatiramer acetate, no waiting period is required when initiating teriflunomide after interferon beta or 
glatiramer acetate or when starting interferon beta or glatiramer acetate, after teriflunomide. 
 
Due to the long half-life of natalizumab, concomitant exposure, and thus concomitant immune effects, could 
occur for up to 2-3 months following discontinuation of natalizumab if AUBAGIO was immediately started. 
Therefore, caution is required when switching patients from natalizumab to AUBAGIO. 
 
Based on the half-life of fingolimod, a 6-week interval without therapy is needed for clearance from the 
circulation and a 1 to 2 month period is needed for lymphocytes to return to normal range following 
discontinuation of fingolimod. Starting AUBAGIO during this interval will result in concomitant exposure to 
fingolimod. This may lead to an additive effect on the immune system and caution is, therefore, indicated. 
 
In MS patients, the median t1/2z was approximately 19 days after repeated doses of 14 mg. If a decision is 
made to stop treatment with AUBAGIO, during the interval of 5 half-lives (approximately 3.5 months 
although may be longer in some patients), starting other therapies will result in concomitant exposure to 
AUBAGIO. This may lead to an additive effect on the immune system and caution is, therefore, indicated. 
 
Lactose 
 
Since AUBAGIO tablets contain lactose, patients with rare hereditary problems of galactose intolerance, 
total lactase deficiency or glucose-galactose malabsorption, should not take this medicinal product. 
 
Interference with determination of ionised calcium levels 
 
The measurement of ionised calcium levels might show falsely decreased values under treatment with 
leflunomide and/or teriflunomide (the active metabolite of leflunomide) depending on the type of ionised 
calcium analyser used (e.g. blood gas analyser). Therefore, the plausibility of observed decreased ionised 
calcium levels needs to be questioned in patients under treatment with leflunomide or teriflunomide. In case 
of doubtful measurements, it is recommended to determine the total albumin adjusted serum calcium 
concentration.  
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Pharmacokinetic interactions of other substances on teriflunomide 
 
The primary biotransformation pathway for teriflunomide is hydrolysis, with oxidation being a minor 
pathway. 
 
Potent cytochrome P450 (CYP) and transporter inducers 
Co-administration of repeated doses (600 mg once daily for 22 days) of rifampicin (a CYP2B6, 2C8, 2C9, 
2C19, 3A inducer), as well as an inducer of the efflux transporters P-glycoprotein [P-gp] and breast cancer 
resistant protein [BCRP] with teriflunomide (70 mg single dose) resulted in an approximately 40% decrease 
in teriflunomide exposure. Rifampicin and other known potent CYP and transporter inducers such as 



 

7 

carbamazepine, phenobarbital, phenytoin and St John’s Wort should be used with caution during the 
treatment with teriflunomide. 
 
Cholestyramine or activated charcoal 
It is recommended that patients receiving teriflunomide are not treated with cholestyramine or activated 
charcoal because this leads to a rapid and significant decrease in plasma concentration unless an accelerated 
elimination is desired. The mechanism is thought to be by interruption of enterohepatic recycling and/or 
gastrointestinal dialysis of teriflunomide. 
 
Pharmacokinetic interactions of teriflunomide on other substances 
 
Effect of teriflunomide on CYP2C8 substrate: repaglinide 
There was an increase in mean repaglinide Cmax and AUC (1.7- and 2.4-fold, respectively), following 
repeated doses of teriflunomide, suggesting that teriflunomide is an inhibitor of CYP2C8 in vivo. Therefore, 
medicinal products metabolised by CYP2C8, such as repaglinide, paclitaxel, pioglitazone or rosiglitazone, 
should be used with caution during treatment with teriflunomide. 
 
Effect of teriflunomide on oral contraceptives: 0.03 mg ethinylestradiol and 0.15 mg levonorgestrel 
There was an increase in mean ethinylestradiol Cmax and AUC0-24 (1.58- and 1.54-fold, respectively) and 
levonorgestrel Cmax and AUC0-24 (1.33- and 1.41-fold, respectively) following repeated doses of 
teriflunomide. While this interaction of teriflunomide is not expected to adversely impact the efficacy of oral 
contraceptives, it should be considered when selecting or adjusting oral contraceptive treatment used in 
combination with teriflunomide.  
 
Effect of teriflunomide on CYP1A2 substrate: caffeine 
Repeated doses of teriflunomide decreased mean Cmax and AUC of caffeine (CYP1A2 substrate) by 18% and 
55%, respectively, suggesting that teriflunomide may be a weak inducer of CYP1A2 in vivo. Therefore, 
medicinal products metabolised by CYP1A2 (such as duloxetin, alosetron, theophylline and tizanidine) 
should be used with caution during treatment with teriflunomide, as it could lead to the reduction of the 
efficacy of these medicinal products. 
 
Effect of teriflunomide on warfarin 
Repeated doses of teriflunomide had no effect on the pharmacokinetics of S-warfarin, indicating that 
teriflunomide is not an inhibitor or an inducer of CYP2C9. However, a 25% decrease in peak international 
normalised ratio (INR) was observed when teriflunomide was coadministered with warfarin as compared 
with warfarin alone. Therefore, when warfarin is co-administered with teriflunomide, close INR follow-up 
and monitoring is recommended. 
 
Effect of teriflunomide on organic anion transporter 3 (OAT3) substrates  
There was an increase in mean cefaclor Cmax and AUC (1.43- and 1.54-fold, respectively), following 
repeated doses of teriflunomide, suggesting that teriflunomide is an inhibitor of OAT3 in vivo. Therefore, 
when teriflunomide is coadministered with substrates of OAT3, such as cefaclor, benzylpenicillin, 
ciprofloxacin, indometacin, ketoprofen, furosemide, cimetidine, methotrexate, zidovudine, caution is 
recommended. 
 
Effect of teriflunomide on BCRP and /or organic anion transporting polypeptide B1 and B3 (OATP1B1/B3) 
substrates  
There was an increase in mean rosuvastatin Cmax and AUC (2.65- and 2.51-fold, respectively), following 
repeated doses of teriflunomide. However, there was no apparent impact of this increase in plasma 
rosuvastatin exposure on the HMG-CoA reductase activity. For rosuvastatin, a dose reduction by 50% is 
recommended for coadministration with teriflunomide. For other substrates of BCRP (e.g., methotrexate, 
topotecan, sulfasalazine, daunorubicin, doxorubicin) and the OATP family especially HMG-Co reductase 
inhibitors (e.g., simvastatin, atorvastatin, pravastatin, methotrexate, nateglinide, repaglinide, rifampicin) 
concomitant administration of teriflunomide should also be undertaken with caution. Patients should be 
closely monitored for signs and symptoms of excessive exposure to the medicinal products and reduction of 
the dose of these medicinal products should be considered. 
 



 

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4.6 Fertility, pregnancy and lactation 
 
Use in males 
 
The risk of male-mediated embryo-foetal toxicity through teriflunomide treatment is considered low (see 
section 5.3). 
 
Pregnancy 
 
There are limited amount of data from the use of teriflunomide in pregnant women. Studies in animals have 
shown reproductive toxicity (see section 5.3). 
Teriflunomide may cause serious birth defects when administered during pregnancy. Teriflunomide is 
contraindicated in pregnancy (see section 4.3). 
 
Women of childbearing potential have to use effective contraception during treatment and after treatment as 
long as teriflunomide plasma concentration is above 0.02 mg/l. During this period women should discuss any 
plans to stop or change contraception with the treating physician. 
 
The patient must be advised that if there is any delay in onset of menses or any other reason to suspect 
pregnancy, they must notify the physician immediately for pregnancy testing, and if positive, the physician 
and patient must discuss the risk to the pregnancy. It is possible that rapidly lowering the blood level of 
teriflunomide, by instituting the accelerated elimination procedure described below, at the first delay of 
menses, may decrease the risk to the foetus. 
For women receiving teriflunomide treatment, who wish to become pregnant, the medicinal product should 
be stopped and an accelerated elimination procedure is recommended in order to more rapidly achieve 
concentration below 0.02 mg/l (see below). 
 
If an accelerated elimination procedure is not used, teriflunomide plasma levels can be expected to be above 
0.02 mg/l for an average of 8 months, however, in some patients it may take up to 2 years to reach plasma 
concentration below 0.02 mg/l. Therefore, teriflunomide plasma concentrations should be measured before a 
woman begins to attempt to become pregnant. Once the teriflunomide plasma concentration is determined to 
be below 0.02 mg/l, the plasma concentration must be determined again after an interval of at least 14 days. 
If both plasma concentrations are below 0.02 mg/l, no risk to the foetus is to be expected. 
For further information on the sample testing please contact the Marketing Authorisation Holder or its local 
representative (see section 7). 
 
Accelerated elimination procedure 
 
After stopping treatment with teriflunomide: 
 cholestyramine 8 g is administered 3 times daily for a period of 11 days, or cholestyramine 4 g three 

times a day can be used, if cholestyramine 8 g three times a day is not well tolerated, 
 alternatively, 50 g of activated powdered charcoal is administered every 12 hours for a period of 11 

days. 
 
However, also following either of the accelerated elimination procedures, verification by 2 separate tests at 
an interval of at least 14 days and a waiting period of one-and-a-half months between the first occurrence of 
a plasma concentration below 0.02 mg/l and fertilisation is required. 
Both cholestyramine and activated powdered charcoal may influence the absorption of oestrogens and 
progestogens such that reliable contraception with oral contraceptives may not be guaranteed during the 
accelerated elimination procedure with cholestyramine or activated powdered charcoal. Use of alternative 
contraceptive methods is recommended. 
 
Breast-feeding 
 
Animal studies have shown excretion of teriflunomide in milk. Teriflunomide is contraindicated during 
breast-feeding (see section 4.3).  



 

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Fertility 
 
Results of studies in animals have not shown an effect on fertility (see section 5.3). Although human data are 
lacking, no effect on male and female fertility is anticipated. 
 
4.7 Effects on ability to drive and use machines 
 
AUBAGIO has no or negligible influence on the ability to drive and use machines.   
In the case of adverse reactions such as dizziness, which has been reported with leflunomide, the parent 
compound, the patient’s ability to concentrate and to react properly may be impaired. In such cases, patients 
should refrain from driving and using machines. 
 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
A total of 2267 patients were exposed to teriflunomide (1155 on teriflunomide 7 mg and 1112 on 
teriflunomide 14 mg) once daily for a median duration of about 672 days in four placebo-controlled studies 
(1045 and 1002 patients for teriflunomide 7 mg and 14 mg, respectively) and one active comparator study 
(110 patients in each of the teriflunomide treatment groups) in patients with relapsing forms of MS 
(Relapsing Multiple Sclerosis, RMS). 
Teriflunomide is the main metabolite of leflunomide. The safety profile of leflunomide in patients suffering 
from rheumatoid arthritis or psoriatic arthritis may be pertinent when prescribing teriflunomide in MS 
patients. 
 
The placebo-controlled pooled analysis was based on 2047 patients with Relapsing Multiple Sclerosis treated 
with teriflunomide once daily. Within this safety population, the most commonly reported adverse reactions 
in the teriflunomide treated patients were: headache, diarrhoea, increased ALT, nausea, and alopecia. In 
general, headache, diarrhoea, nausea and alopecia, were mild to moderate, transient and infrequently led to 
treatment discontinuation.  
 
Tabulated list of adverse reactions 
 
Adverse reactions reported with AUBAGIO in placebo-controlled studies, reported for teriflunomide 7 mg or 
14 mg at ≥ 1% higher rate than for placebo, are shown below. Frequencies were defined using the following 
convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare 
(≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). 
Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.  



 

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System organ 

class 
Very 

common 
Common Uncommon Rare Very 

rare 
Not known 

Infections and 
infestations 

 
 
 

Influenza, 
Upper 
respiratory tract 
infection,  
Urinary tract 
infection, 
Bronchitis, 
Sinusitis, 
Pharyngitis, 
Cystitis, 
Gastroenteritis 
viral, 
Oral herpes, 
Tooth infection, 
Laryngitis, 
Tinea pedis 

   Severe 
infections 
including 
sepsisa 

Blood and 
lymphatic 
system disorders 

 Neutropeniab, 
Anaemia 

Mild 
thrombocytopen
ia (platelets 
<100G/l) 

   

Immune system 
disorders 

 Mild allergic 
reactions  

   Hyper-
sensitivity 
reactions 
(immediate 
or delayed) 
including 
anaphylaxis 
and 
angioedema 

Psychiatric 
disorders 

 Anxiety     

Nervous system 
disorders 

Headache Paraesthesia, 
Sciatica, 
Carpal tunnel 
syndrome 
 

Hyperaesthesia, 
Neuralgia, 
Peripheral 
neuropathy 

   

Cardiac 
disorders 

 Palpitations     

Vascular 
disorders 

 Hypertensionb     

Respiratory, 
thoracic and 
mediastinal 
disorders 

     Interstitial 
lung disease 

Gastrointestinal 
disorders 

Diarrhoea, 
Nausea 

Abdominal pain 
upper, 
Vomiting, 
Toothache 

   
 

Pancreatitis, 
Stomatitis 

Hepatobiliary 
disorders 

Alanine 
aminotransfer
ase (ALT) 
increaseb 

Gamma-
glutamyltransfer
ase (GGT) 
increaseb, 
Aspartate 
aminotransferas

   Acute 
hepatitis 



 

11 

System organ 
class 

Very 
common 

Common Uncommon Rare Very 
rare 

Not known 

e increaseb 
Metabolism and 
nutrition 
disorders 

     Dyslipidaem
ia 

Skin and 
subcutaneous 
tissue disorders 

Alopecia Rash, Acne Nail disorders   Severe skin 
reactionsa, 
Psoriasis 
(including 
pustular)b 

Musculoskeletal 
and connective 
tissue disorders 

 Musculoskeletal 
pain, 
Myalgia, 
Arthralgia 

    

Renal and 
urinary disorders 

 Pollakiuria     

Reproductive 
system and 
breast disorders 

 Menorrhagia     

General 
disorders and 
administration 
site conditions 

 Pain, Astheniaa     

Investigations  Weight 
decrease, 
Neutrophil 
count decreaseb, 
White blood cell 
count decreaseb, 
Blood creatine 
phosphokinase 
increased 

    

Injury, poisoning 
and procedural 
complications 

  Post-traumatic 
pain 

   

 
a: please refer to the detailed description section 
b: see section 4.4 
 
Description of selected adverse reactions 
 
Alopecia 
Alopecia was reported as hair thinning, decreased hair density, hair loss, associated or not with hair texture 
change, in 13.9% of patients treated with 14 mg teriflunomide versus 5.1% in patients treated with placebo. 
Most cases were described as diffuse or generalised over the scalp (no complete hair loss reported) and 
occurred most often during the first 6 months and with resolution in 121 of 139 (87.1%) patients treated with 
teriflunomide 14 mg. Discontinuation because of alopecia was 1.3% in the teriflunomide 14 mg 
teriflunomide group, versus 0.1% in the placebo group.  
 
Hepatic effects 
During placebo-controlled studies the following was detected: 
 



 

12 

ALT increase (based on laboratory data) according to baseline status - Safety population in placebo-
controlled studies 

 
Placebo 
(N=997) 

Teriflunomide 14 mg 
(N=1002) 

>3 ULN 66/994 (6.6%) 80/999 (8.0%) 
>5 ULN 37/994 (3.7%) 31/999 (3.1%) 
>10 ULN 16/994 (1.6%) 9/999 (0.9%) 
>20 ULN 4/994 (0.4%) 3/999 (0.3%) 
ALT >3 ULN and TBILI >2 ULN 5/994 (0.5%) 3/999 (0.3%) 
 
Mild increases in transaminase, ALT below or equal to 3-fold ULN were more frequently seen in 
teriflunomide-treated groups as compared to placebo. The frequency of elevations above 3-fold ULN and 
higher was balanced across treatment groups. These elevations in transaminase occurred mostly within the 
first 6 months of treatment and were reversible after treatment cessation. The recovery time varied between 
months and years. 
 
Blood pressure effects 
In placebo-controlled studies the following was established: 
-  systolic blood pressure was >140 mm Hg in 19.9% of patients receiving 14 mg/day teriflunomide as 

compared to 15.5% receiving placebo;  
-  systolic blood pressure was >160 mm Hg in 3.8% of patients receiving 14 mg/day teriflunomide as 

compared to 2.0% receiving placebo; 
-  diastolic blood pressure was >90 mm Hg in 21.4% of patients receiving 14 mg/day teriflunomide as 

compared to 13.6% receiving placebo. 
 
Infections 
In placebo-controlled studies, no increase in serious infections was observed with teriflunomide 14 mg 
(2.7%) as compared to placebo (2.2%). Serious opportunistic infections occurred in 0.2% of each group. 
Severe infections including sepsis, sometimes fatal have been reported postmarketing.  
 
Haematological effects 
A mean decrease affecting white blood cell (WBC) count (<15% from baseline levels, mainly neutrophil and 
lymphocytes decrease) was observed in placebo-controlled trials with AUBAGIO, although a greater 
decrease was observed in some patients. The decrease in mean count from baseline occurred during the first 
6 weeks then stabilised over time while on-treatment but at decreased levels (less than a 15% decrease from 
baseline). The effect on red blood cell (RBC) (<2%) and platelet counts (<10%) was less pronounced. 
 
Peripheral neuropathy 
In placebo-controlled studies, peripheral neuropathy, including both polyneuropathy and mononeuropathy 
(e.g., carpal tunnel syndrome), was reported more frequently in patients taking teriflunomide than in patients 
taking placebo. In the pivotal, placebo-controlled studies, the incidence of peripheral neuropathy confirmed 
by nerve conduction studies was 1.9% (17 patients out of 898) on 14 mg of teriflunomide, compared with 
0.4% (4 patients out of 898) on placebo. Treatment was discontinued in 5 patients with peripheral 
neuropathy on teriflunomide 14 mg. Recovery following treatment discontinuation was reported in 4 of these 
patients. 
 
Neoplasms benign, malignant and unspecified (incl. cysts and polyps) 
There does not appear to be an increased risk of malignancy with teriflunomide in the clinical trial 
experience. The risk of malignancy, particularly lymphoproliferative disorders, is increased with use of some 
other agents that affect the immune system (class effect).  
 
Severe skin reactions  
Cases of severe skin reactions have been reported with teriflunomide post-marketing (see section 4.4). 
 
Asthenia 
In placebo-controlled studies, frequencies for asthenia were 2.0%, 1.6% and 2.2% in the placebo, 
teriflunomide 7 mg and teriflunomide 14 mg group, respectively. 



 

13 

Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows 
continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked 
to report any suspected adverse reactions via the national reporting system listed in Appendix V. 
 
4.9 Overdose  
 
Symptoms  
 
There is no experience regarding teriflunomide overdose or intoxication in humans. Teriflunomide 70 mg 
daily was administered up to 14 days in healthy subjects. The adverse reactions were consistent with the 
safety profile for teriflunomide in MS patients. 
 
Management  
 
In the event of relevant overdose or toxicity, cholestyramine or activated charcoal is recommended to 
accelerate elimination. The recommended elimination procedure is cholestyramine 8 g three times a day for 
11 days. If this is not well tolerated, cholestyramine 4 g three times a day for 11 days can be used. 
Alternatively, when cholestyramine is not available, activated charcoal 50 g twice a day for 11 days may also 
be used. In addition, if required for tolerability reasons, administration of cholestyramine or activated 
charcoal does not need to occur on consecutive days (see section 5.2). 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Immunosuppressants, Selective immunosuppressants, ATC Code: L04AA31 
 
Mechanism of action 
 
Teriflunomide is an immunomodulatory agent with anti-inflammatory properties that selectively and 
reversibly inhibits the mitochondrial enzyme dihydroorotate dehydrogenase (DHO-DH), required for the de 
novo pyrimidine synthesis. As a consequence teriflunomide reduces the proliferation of dividing cells that 
need de novo synthesis of pyrimidine to expand. The exact mechanism by which teriflunomide exerts its 
therapeutic effect in MS is not fully understood, but this is mediated by a reduced number of lymphocytes. 
 
Pharmacodynamic effects 
 
Immune system 
Effects on immune cell numbers in the blood: In the placebo-controlled studies, teriflunomide 14 mg once a 
day led to a mild mean reduction in lymphocyte count, of less than 0.3 x 109/l, which occurred over the first 
3 months of treatment and levels were maintained until the end of the treatment. 
 
Potential to prolong the QT interval 
In a placebo-controlled thorough QT study performed in healthy subjects, teriflunomide at mean steady-state 
concentrations did not show any potential for prolonging the QTcF interval compared with placebo: the 
largest time matched mean difference between teriflunomide and placebo was 3.45 ms with the upper bound 
of the 90% CI being 6.45 ms.  
 
Effect on renal tubular functions 
In the placebo-controlled studies, mean decreases in serum uric acid at a range of 20 to 30% were observed 
in patients treated with teriflunomide compared to placebo. Mean decrease in serum phosphorus was around 
10% in the teriflunomide group compared to placebo. These effects are considered to be related to increase 
in renal tubular excretion and not related to changes in glomerular functions. 
 



 

14 

Clinical efficacy and safety 
 
The efficacy of AUBAGIO was demonstrated in two placebo controlled studies, the TEMSO and the 
TOWER study, that evaluated once daily doses of teriflunomide 7 mg and 14 mg in patients with RMS. 
 
A total of 1088 patients with RMS were randomised in TEMSO to receive 7 mg (n=366) or 14 mg (n=359) 
of teriflunomide or placebo (n= 363) for 108 weeks duration. All patients had a definite diagnosis of MS 
(based on McDonald criteria (2001)), exhibited a relapsing clinical course, with or without progression, and 
experienced at least 1 relapse over the year preceding the trial or at least 2 relapses over the 2 years 
preceding the trial. At entry, patients had an Expanded Disability Status Scale (EDSS) score ≤5.5.  
The mean age of the study population was 37.9 years. The majority of patients had relapsing–remitting 
multiple sclerosis (91.5%), but a subgroup of patients had secondary progressive (4.7%) or progressive 
relapsing multiple sclerosis (3.9%). The mean number of relapses within the year before study inclusion was 
1.4 with 36.2% of patients having gadolinium-enhancing lesions at baseline. The median EDSS score at 
baseline was 2.50; 249 patients (22.9%) had an EDSS score › 3.5 at baseline. The mean duration of disease, 
since first symptoms, was 8.7 years. A majority of patients (73%) had not received disease-modifying 
therapy during the 2 years before study entry. The study results are shown in Table 1.  
 
Long term follow-up results from TEMSO long term extension safety study (overall median treatment 
duration approximately 5 years, maximum treatment duration approximately 8.5 years) did not present any 
new or unexpected safety findings. 
 
A total of 1169 patients with RMS were randomised in TOWER to receive 7 mg (n=408) or 14 mg (n=372) 
of teriflunomide or placebo (n= 389) for a variable treatment duration ending at 48 weeks after last patient 
randomised. All patients had a definite diagnosis of MS (based on McDonald criteria (2005)), exhibited a 
relapsing clinical course, with or without progression, and experienced at least 1 relapse over the year 
preceding the trial or at least 2 relapses over the 2 years preceding the trial. At entry, patients had an 
Expanded Disability Status Scale (EDSS) score ≤5.5.  
The mean age of the study population was 37.9 years. The majority of patients had relapsing–remitting 
multiple sclerosis (97.5%), but a subgroup of patients had secondary progressive (0.8%) or progressive 
relapsing multiple sclerosis (1.7%). The mean number of relapses within the year before study inclusion was 
1.4. Gadolinium-enhancing lesions at baseline: no data. The median EDSS score at baseline was 2.50; 298 
patients (25.5%) had an EDSS score › 3.5 at baseline. The mean duration of disease, since first symptoms, 
was 8.0 years. A majority of patients (67.2%) had not received disease-modifying therapy during the 2 years 
before study entry. The study results are shown in Table 1. 
 



 

15 

Table 1 - Main Results ( for the approved dose, ITT population) 
 
 TEMSO-study TOWER-study  

 Teriflunomide  14 mg Placebo 
Teriflunomide  

14 mg Placebo 

N 358 363 370 388 
Clinical Outcomes      
Annualised relapse rate 0.37 0.54 0.32 0.50 

Risk difference (CI95%) -0.17 (-0.26, -0.08) -0.18 (-0.27, -0.09) 
Relapse-free week 108 56.5% 45.6% 57.1% 46.8% 

Hazard ratio (CI95%) 0.72, (0.58, 0.89) 0.63, (0.50, 0.79) 
3-month Sustained 
Disability Progression week 
108 

20.2% 27.3% 15.8% 19.7% 

Hazard ratio (CI95%) 0.70 (0.51, 0.97) 0.68 (0.47, 1.00) 
6-month Sustained 
Disability Progression week 
108 

13.8% 18.7% 11.7% 11.9% 

Hazard ratio (CI95%) 0.75 (0.50, 1.11) 0.84 (0.53, 1.33) 
MRI endpoints    

Not measured 

Change in BOD week 108(1) 0.72  2.21 
Change relative to placebo  67% 

Mean Number of Gd-
enhancing lesions at week 
108 

0.38 1.18 

Change relative to placebo 
(CI95%) -0.80 (-1.20, -0.39)

 

Number of unique active 
lesions /scan  0.75 2.46 

Change relative to placebo 
(CI95%) 69%, (59%; 77%)

 
 p<0.0001  p<0.001  p<0.01  p<0.05 compared to placebo 
(1) BOD: burden of disease: total lesion volume (T2 and T1 hypointense) in ml 
 
Efficacy in patients with high disease activity: 
A consistent treatment effect on relapses and time to 3-month sustained disability progression in a subgroup 
of patients in TEMSO (n 127) with high disease activity was observed. Due to the design of the study, high 
disease activity was defined as 2 or more relapses in one year, and with one or more Gd-enhancing lesion on 
brain MRI. No similar subgroup analysis was performed in TOWER as no MRI data were obtained. 
No data are available in patients who have failed to respond to a full and adequate course (normally at least 
one year of treatment) of beta-interferon, having had at least 1 relapse in the previous year while on therapy, 
and at least 9 T2-hyperintense lesions in cranial MRI or at least 1 Gd-enhancing lesion, or patients having an 
unchanged or increased relapse rate in the prior year as compared to the previous 2 years.  
 
TOPIC was a double-blind, placebo-controlled study that evaluated once daily doses of teriflunomide 7 mg 
and 14 mg for up to 108 weeks in patients with first clinical demyelinating event (mean age 32.1 years). The 
primary endpoint was time to a second clinical episode (relapse). A total of 618 patients were randomised to 
receive 7 mg (n=205) or 14 mg (n=216) of teriflunomide or placebo (n=197). The risk of a second clinical 
attack over 2 years was 35.9% in the placebo group and 24.0% in the teriflunomide 14 mg treatment group 
(hazard ratio: 0.57, 95% confidence interval: 0.38 to 0.87, p=0.0087). The results from the TOPIC study 
confirmed the efficacy of teriflunomide in RRMS (including early RRMS with first clinical demyelinating 
event and MRI lesions disseminated in time and space). 
 
Teriflunomide effectiveness was compared to that of a subcutaneous interferon beta-1a (at the recommended 
dose of 44 µg three times a week) in 324 randomised patients in a study (TENERE) with minimum treatment 
duration of 48 weeks (maximum 114 weeks). The risk of failure (confirmed relapse or permanent treatment 



 

16 

discontinuation whichever came first) was the primary endpoint. The number of patients with permanent 
treatment discontinuation in the teriflunomide 14 mg group was 22 out of 111 (19.8%), the reasons being 
adverse events (10.8%), lack of efficacy (3.6%), other reason (4.5%) and lost to follow-up (0.9%). The 
number of patients with permanent treatment discontinuation in the subcutaneous interferon beta-1a group 
was 30 out of 104 (28 .8%), the reasons being adverse events (21.2%), lack of efficacy (1.9%), other reason 
(4.8%) and poor compliance to protocol (1%). Teriflunomide 14 mg/day was not superior to interferon beta-
1a on the primary endpoint: the estimated percentage of patients with treatment failure at 96 weeks using the 
Kaplan-Meier method was 41.1% versus 44.4% (teriflunomide 14 mg versus interferon beta-1a group, 
p=0.595). 
 
Paediatric population 
 
The European Medicines Agency has waived the obligation to submit the results of studies with AUBAGIO 
in children from birth to less than 10 years in treatment of multiple sclerosis (see section 4.2 for information 
on paediatric use). 
The European Medicines Agency has deferred the obligation to submit the results of studies with AUBAGIO 
in one or more subsets of the paediatric population in multiple sclerosis (see section 4.2 for information on 
paediatric use).  
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
Median time to reach maximum plasma concentrations occurs between 1 to 4 hours post-dose following 
repeated oral administration of teriflunomide, with high bioavailability (approximately 100%). 
 
Food does not have a clinically relevant effect on teriflunomide pharmacokinetics. 
 
From the mean predicted pharmacokinetic parameters calculated from the population pharmacokinetic 
(PopPK) analysis using data from healthy volunteers and MS patients, there is a slow approach to steady-
state concentration (i.e., approximately 100 days (3.5 months) to attain 95% of steady-state concentrations) 
and the estimated AUC accumulation ratio is approximately 34-fold. 
 
Distribution 
 
Teriflunomide is extensively bound to plasma protein (>99%), probably albumin and is mainly distributed in 
plasma. The volume of distribution is 11 l after a single intravenous (IV) administration. However, this is 
most likely an underestimation since extensive organ distribution was observed in rats. 
 
Biotransformation 
 
Teriflunomide is moderately metabolised and is the only component detected in plasma. The primary 
biotransformation pathway for teriflunomide is hydrolysis with oxidation being a minor pathway. Secondary 
pathways involve oxidation, N-acetylation and sulfate conjugation. 
 
Elimination 
 
Teriflunomide is excreted in the gastrointestinal tract mainly through the bile as unchanged medicinal 
product and most likely by direct secretion. Teriflunomide is a substrate of the efflux transporter BCRP, 
which could be involved in direct secretion. Over 21 days, 60.1% of the administered dose is excreted via 
feces (37.5%) and urine (22.6%). After the rapid elimination procedure with cholestyramine, an additional 
23.1% was recovered (mostly in feces). Based on individual prediction of pharmacokinetic parameters using 
the PopPK model of teriflunomide in healthy volunteers and MS patients, median t1/2z was approximately 
19 days after repeated doses of 14 mg. After a single intravenous administration, the total body clearance of 
teriflunomide is 30.5 ml/h. 
 
Accelerated Elimination Procedure: Cholestyramine and activated charcoal  



 

17 

The elimination of teriflunomide from the circulation can be accelerated by administration of cholestyramine 
or activated charcoal, presumably by interrupting the reabsorption processes at the intestinal level. 
Teriflunomide concentrations measured during an 11-day procedure to accelerate teriflunomide elimination 
with either 8 g cholestyramine three times a day, 4 g cholestyramine three times a day or 50 g activated 
charcoal twice a day following cessation of teriflunomide treatment have shown that these regimens were 
effective in accelerating teriflunomide elimination, leading to more than 98% decrease in teriflunomide 
plasma concentrations, with cholestyramine being faster than charcoal. Following discontinuation of 
teriflunomide and the administration of cholestyramine 8 g three times a day, the plasma concentration of 
teriflunomide is reduced 52% at the end of day 1, 91% at the end of day 3, 99.2% at the end of day 7, and 
99.9% at the completion of day 11. The choice between the 3 elimination procedures should depend on the 
patient’s tolerability. If cholestyramine 8 g three times a day is not well-tolerated, cholestyramine 4 g three 
times a day can be used. Alternatively, activated charcoal may also be used (the 11 days do not need to be 
consecutive unless there is a need to lower teriflunomide plasma concentration rapidly). 
 
Linearity/non-linearity 
 
Systemic exposure increases in a dose proportional manner after oral administration teriflunomide from 7 to 
14 mg.  
 
Characteristics in specific groups of patients 
 
Gender, Elderly, Paediatric patients 
Several sources of intrinsic variability were identified in healthy subjects and MS patients based on the 
PopPK analysis: age, body weight, gender, race, and albumin and bilirubin levels. Nevertheless, their impact 
remains limited (31%). 
 
Hepatic impairment 
Mild and moderate hepatic impairment had no impact on the pharmacokinetic of teriflunomide. Therefore no 
dose adjustment is anticipated in mild and moderate hepatic-impaired patients. However, teriflunomide is 
contraindicated in patients with severe hepatic impairment (see sections 4.2 and 4.3). 
 
Renal impairment 
Severe renal impairment had no impact on the pharmacokinetic of teriflunomide. Therefore no dose 
adjustment is anticipated in mild, moderate and severe renal-impaired patients. 
 
5.3 Preclinical safety data 
 
Repeated oral administration of teriflunomide to mice, rats and dogs for up to 3, 6, and 12 months, 
respectively, revealed that the major targets of toxicity were the bone marrow, lymphoid organs, oral cavity/ 
gastro intestinal tract, reproductive organs, and pancreas. Evidence of an oxidative effect on red blood cells 
was also observed. Anemia, decreased platelet counts and effects on the immune system, including 
leukopenia, lymphopenia and secondary infections, were related to the effects on the bone marrow and/or 
lymphoid organs. The majority of effects reflect the basic mode of action of the compound (inhibition of 
dividing cells). Animals are more sensitive to the pharmacology, and therefore toxicity, of teriflunomide than 
humans. As a result, toxicity in animals was found at exposures equivalent or below human therapeutic 
levels.  
 
Teriflunomide was not mutagenic in vitro or clastogenic in vivo. Clastogenicity observed in vitro was 
considered to be an indirect effect related to nucleotide pool imbalance resulting from the pharmacology of 
DHO-DH inhibition. The minor metabolite TFMA (4-trifluoromethylaniline) caused mutagenicity and 
clastogenicity in vitro but not in vivo. 
 
No evidence of carcinogenicity was observed in rats and mice. 
 
Fertility was unaffected in rats despite adverse effects of teriflunomide on male reproductive organs, 
including reduced sperm count. There were no external malformations in the offspring of male rats 
administered teriflunomide prior to mating with untreated female rats. Teriflunomide was embryotoxic and 



 

18 

teratogenic in rats and rabbits at doses in the human therapeutic range. Adverse effects on the offspring were 
also seen when teriflunomide was administered to pregnant rats during gestation and lactation. The risk of 
male-mediated embryo-fetal toxicity through teriflunomide treatment is considered low. The estimated 
female plasma exposure via the semen of a treated patient is expected to be 100 times lower than the plasma 
exposure after 14 mg of oral teriflunomide. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Tablet core 
 
lactose monohydrate 
maize starch 
microcrystalline cellulose 
sodium starch glycolate (Type A) 
hydroxypropylcellulose 
magnesium stearate 
 
Tablet coating 
 
hypromellose 
titanium dioxide (E171) 
talc 
macrogol 8000 
indigo carmine aluminum lake (E132) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container  
 
Polyamide/aluminium/poly(vinyl chloride) -aluminium blisters inserted in wallets (14 and 28 film-coated 
tablets) and packed in cartons containing 14, 28, 84 (3 wallets of 28), and 98 (7 wallets of 14) film-coated 
tablets. 
Each wallet is placed in a protective sleeve. 
 
Polyamide/aluminium/poly(vinyl chloride) -aluminium perforated unit-dose blister packs in cartons 
containing 10x1 film-coated tablets. 
 
Not all pack sizes may be marketed.  
 
6.6 Special precautions for disposal  
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 



 

19 

 
7. MARKETING AUTHORISATION HOLDER 
 
sanofi-aventis groupe 
54, rue La Boétie 
F-75008 Paris 
France 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/838/001 
EU/1/13/838/002 
EU/1/13/838/003 
EU/1/13/838/004 
EU/1/13/838/005 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 26 August 2013 
Date of latest renewal: 28 May 2018 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 



 

20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND 

USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT   
 
 



 

21 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer(s) responsible for batch release 
 
Sanofi Winthrop Industrie 
56, Route de Choisy au Bac 
F-60205 Compiegne Cedex 
France 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  
 
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2). 
 
 
C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
 
 Periodic Safety Update Reports 
 
The requirements for submission of periodic safety update reports for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal. 
 
The marketing authorisation holder shall submit the first periodic safety update report for this product within 
6 months following authorisation. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE 

OF THE MEDICINAL PRODUCT   
 
 Risk Management Plan (RMP) 

 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed 
RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the 
RMP. 
 
An updated RMP should be submitted: 
• At the request of the European Medicines Agency;  
• Whenever the risk management system is modified, especially as the result of new information being 

received that may lead to a significant change to the benefit/risk profile or as the result of an important 
(pharmacovigilance or risk minimisation) milestone being reached. 

 
If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time. 
 
 Additional risk minimisation measures   
 
Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree an educational 
programme with the National Competent Authority. 
The MAH shall ensure that, following discussion and agreement with the National Competent Authorities in 
each Member State where AUBAGIO is marketed, at launch and after launch, all healthcare professionals 
who are expected to use AUBAGIO are provided with the following items: 

 Summary of Product Characteristics (SmPC)  
 Educational material for Healthcare professionals  
 Educational card for patients 

 



 

22 

The educational material for HealthCare Professionals (HCP) will include the following key elements:  
 
1. HCPs should discuss with their patients the specific safety concerns of AUBAGIO detailed below 
including the tests and precautions needed for safe use as follows: 

 Risk of hepatic effects 
o liver function tests are needed prior to treatment and periodically during treatment 
o To educate the patient about the signs and symptoms of liver disease and the need to report 

to their HCP if they experience any of them 
 Potential risk of teratogenicity 

o To check pregnancy status before starting treatment 
o To educate female patients of child-bearing potential on the need for effective contraception 

before starting, and during treatment with teriflunomide 
o To inform their doctor immediately if they stop contraception, or prior to changing 

contraceptive measures  
o If female patients become pregnant despite using contraceptive measures, they should stop 

teriflunomide and contact their doctor immediately who should: 
 Consider and discuss with the patient the accelerated elimination procedure 
 Encourage them to enrol in a pregnancy registry (in countries where a pregnancy 

registry is on-going),  
 Contact the National Registry Coordinator in the respective country who manages 

the enrollment of patient in the pregnancy registry (in countries where a pregnancy 
registry is on-going). 

 Risk of hypertension 
o to check for a history of hypertension and that blood pressure should be appropriately 

managed during treatment 
o the need for blood pressure checks before treatment and periodically during treatment,  

 Risk of hematologic effects 
o To discuss the risk of decreased blood cell counts (affecting mainly white blood cells) and 

the need for complete blood cell counts before treatment and periodically during treatment 
based on signs and symptoms. 

 Risk of infections/serious infections 
o To discuss the need to contact the doctor in the event of signs/symptoms of infection, or if 

the patient takes other medicines that affect the immune system. If serious infection occurs, 
consider the accelerated elimination procedure.  

2. A reminder to provide patients with a Patient Education Card, including filling-in their contact details, and 
to provide replacement Patient Education Cards as necessary; 
3. A reminder to discuss the Patient Education Card content with the patient regularly during each 
consultation at least annually during treatment; 
4. To encourage patients to contact their MS physician and/or General Practitioner if they experience any of 
the signs and symptoms discussed in the Patient Education Card;  
5. Information on the optional service of a periodic reminder to patients on the MS One to One website about 
the continued need for effective contraception during treatment.   
6. At prescription renewal, adverse events are checked, ongoing risks and their prevention are discussed, and 
checks are made to ensure adequate monitoring is taking place. 
 
The educational card for the patients will include the following key elements: 
1. A reminder for both patients and all HCPs involved in their treatment that the patient is being treated with 
teriflunomide, a medicine which:  

 Requires concomitant use of effective contraception in women of child-bearing potential 
 Requires a pregnancy status check before treatment 
 Affects liver function 
 Affects blood cell counts and the immune system 

2. Information to educate the patient: 
 To pay attention to certain signs and symptoms which might indicate liver disease or infection, and if 

any of these occur, to contact their doctor/HCP promptly 



 

23 

 Of the need for the procedures/tests before and during teriflunomide treatment. Blood, liver tests and 
blood pressure will be checked before the start of the treatment and regularly thereafter.  

 To remind female patients to tell their doctor if breastfeeding 
 For women of child-bearing potential 

o to emphasise the need for effective contraception during treatment with teriflunomide 
o to stop treatment with teriflunomide immediately if they suspect they might be pregnant and 

also to contact their doctor immediately  
 To remind patients to show the Patient Education Card to Doctors/HCPs involved with their medical 

care (especially in the event of medical emergencies and/or if new Doctors/HCPs are involved.) 
 To record the first date of prescription and the contact details of their prescriber 

3. To encourage the patients to read the PIL thoroughly 
4. If they become pregnant: 

 To remind both patients and HCPs about the accelerated elimination procedure 
 To remind both patients and HCP about the Pregnancy Registry (in countries where pregnancy 

registry is on-going) 
 

 
 



 

24 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 

 



 

25 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 

   
 
 
 

A. LABELLING 
 



 

26 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
AUBAGIO 14 mg film-coated tablets 
teriflunomide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 14 mg of teriflunomide.  
 
 
3. LIST OF EXCIPIENTS 
 
Also contains: lactose. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 film-coated tablets 
28 film-coated tablets 
84 (3 wallets of 28) film-coated tablets 
98 (7 wallets of 14) film-coated tablets 
10x1 film-coated tablet 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 

 
 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 
THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



 

27 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
sanofi-aventis groupe 
54, rue La Boétie 
F – 75008 Paris 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/838/001 14 tablets  
EU/1/13/838/002 28 tablets 
EU/1/13/838/003 84 tablets 
EU/1/13/838/004 98 tablets  
EU/1/13/838/005 10x1 tablet 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
AUBAGIO 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN: 
NN:  



 

28 

 
PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING 
 
PROTECTIVE SLEEVE CONTAINING WALLET 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
AUBAGIO 14 mg film-coated tablets 
teriflunomide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 14 mg of teriflunomide.    
 
 
3. LIST OF EXCIPIENTS 
 
Also contains: lactose. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 film-coated tablets 
28 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



 

29 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
sanofi-aventis groupe 
54, rue La Boétie  
F - 75008 Paris 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Not applicable. 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 
 



 

30 

PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING 
 
WALLET  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
AUBAGIO 14 mg film-coated tablets 
teriflunomide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 14 mg of teriflunomide.    
 
 
3. LIST OF EXCIPIENTS 
 
Also contains: lactose. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 film-coated tablets 
28 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
Calendar days 
Mon 
Tue 
Wed 
Thu 
Fri 
Sat 
Sun 
 
Week 1 (wallets of 14 and 28) 
Week 2 (wallets of 14 and 28) 
Week 3 (wallets of 28) 
Week 4 (wallets of 28) 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 



 

31 

 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
sanofi-aventis groupe 
54, rue La Boétie 
F - 75008 Paris 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Not applicable. 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 



 

32 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
UNIT-DOSE BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
AUBAGIO 14 mg tablets 
teriflunomide 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
sanofi-aventis groupe 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



 

33 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER FOR WALLET 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
AUBAGIO 14 mg 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



 

34 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 



 

35 

Package leaflet: Information for the patient 
 

AUBAGIO 14 mg film-coated tablets 
teriflunomide 

 
 
Read all of this leaflet carefully before you start taking this medicine because it contains important 
information for you. 
- Keep this leaflet. You may need to read it again.  
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if 

their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 

not listed in this leaflet. See section 4. 
 
What is in this leaflet 
1. What AUBAGIO is and what it is used for  
2. What you need to know before you take AUBAGIO 
3. How to take AUBAGIO  
4. Possible side effects  
5. How to store AUBAGIO  
6. Contents of the pack and other information 
 
 
1. What AUBAGIO is and what it is used for 
 
What AUBAGIO is 
AUBAGIO contains the active substance teriflunomide which is an immunomodulatory agent and adjusts the 
immune system to limit its attack on the nervous system.  
 
What AUBAGIO is used for 
AUBAGIO is used in adults to treat relapsing remitting multiple sclerosis (MS). 
 
What multiple sclerosis is 
MS is a long-term illness that affects the central nervous system (CNS). The CNS is made up of the brain 
and spinal cord. In multiple sclerosis, inflammation destroys the protective sheath (called myelin) around the 
nerves in the CNS. This loss of myelin is called demyelination. This stops nerves from working properly.  
 
People with relapsing form of multiple sclerosis will have repeated attacks (relapses) of physical symptoms 
caused by their nerves not working properly. These symptoms vary from patient to patient but usually 
involve: 
• difficulty walking 
•  vision problems 
•  balance problems. 
 
Symptoms may disappear completely after the relapse is over, but over time, some problems may remain 
between relapses. This can cause physical disabilities that may interfere with your daily activities. 
 
How AUBAGIO works 
AUBAGIO helps to protect against attacks on the central nervous system by the immune system by limiting 
the increase of some white blood cells (lymphocytes). This limits the inflammation that leads to nerve 
damage in MS. 
 
 



 

36 

2. What you need to know before you take AUBAGIO  
 
Do not take AUBAGIO: 
- if you are allergic to teriflunomide or any of the other ingredients of this medicine (listed in section 6), 
- if you have severe liver problems, 
- if you are pregnant, think you may be pregnant, or are breast-feeding, 
- if you suffer from a serious problem which affects your immune system e.g. acquired 

immunodeficiency syndrome (AIDS), 
- if you have a serious problem with your bone marrow, or if you have low numbers of red or white 

cells in your blood or a reduced number of blood platelets, 
- if you are suffering from a serious infection, 
- if you have severe kidney problems which require dialysis, 
- if you have very low levels of proteins in your blood (hypoproteinaemia), 
If you are not sure, talk to your doctor or pharmacist before taking this medicine. 
 
Warnings and precautions 
Talk to your doctor or pharmacist before taking AUBAGIO if: 
-  you have liver problems and/or if you drink large amounts of alcohol. Your doctor will carry out blood 

tests before and during treatment to check how well your liver is working. If your test results show a 
problem with your liver, your doctor may stop your treatment with AUBAGIO. Please read section 4. 

-  you have high blood pressure (hypertension) whether it is controlled with medicines or not. 
AUBAGIO can cause an increase in blood pressure. Your doctor will check your blood pressure 
before the start of treatment and regularly thereafter. Please read section 4. 

-  you have an infection. Before you take AUBAGIO, your doctor will make sure you have enough white 
blood cells and platelets in your blood. As AUBAGIO decreases the number of white cells in the 
blood this may affect your ability to fight the infection. Your doctor may do blood tests to check your 
white blood cells if you think you have an infection. Please read section 4. 

- you have severe skin reactions. 
- you have respiratory symptoms. 
- you have weakness, numbness and pain in the hands and feet. 
- you are going to have a vaccination. 
- you take leflunomide with AUBAGIO. 
- you are switching to or from AUBAGIO. 
- you are lactose intolerant.  
- you are due to have a specific blood test (calcium level). Falsely low levels of calcium can be detected. 
 
Children and adolescents 
AUBAGIO should not be used in children and adolescents under 18 years of age. This is because the effects 
of the medicine in this age group are not known.  
 
Other medicines and AUBAGIO  
Tell your your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 
This includes medicines obtained without a prescription. 
In particular, tell your doctor or pharmacist if you are taking any of the following:  
- leflunomide, methotrexate and other medicines that affect the immune system (often called 

immunosuppressants or immunomodulators) 
- rifampicin (a medicine used to treat tuberculosis and other infections) 
- carbamazepine, phenobarbital, phenytoin for epilepsy 
- St John’s wort (a herbal medicine for depression) 
- repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes 
- daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer 
- duloxetine for depression, urinary incontinenece or in kidney disease in diabetics 
- alosetron for the management of severe diarrhea 
- theophylline for asthma 
- tizanidine, a muscle relaxant 
- warfarin, an anticoagulant used to make the blood thinner (i.e. more fluid) in order to avoid blood clots 
- oral contraceptives (containing ethinylestradiol and levonorgestrel) 



 

37 

- cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections 
- indometacin, ketoprofen for pain or inflammation 
- furosemide for heart disease 
- cimetidine for reducing gastric acid 
- zidovudine for HIV infection 
- rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol) 
- sulfasalazine for inflammatory bowel disease or rheumatoid arthritis 
- cholestyramine for high cholesterol or relief from itching in liver disease 
- activated charcoal to reduce absorption of medicines or other substances 
 
Pregnancy and breast-feeding  
 
Do not take AUBAGIO if you are, or think you may be pregnant. If you are pregnant or become pregnant 
while taking AUBAGIO, the risk of having a baby with birth defects is increased. Women of childbearing 
potential must not take this medicine without using reliable contraceptive measures. 
 
Tell your doctor if you plan to become pregnant after stopping treatment with AUBAGIO, as you need to 
ensure that most of this medicine has left your body before trying to become pregnant. The elimination of the 
active substance may take up to 2 years to occur naturally. The time can be reduced to a few weeks by taking 
certain medicines which speed up removal of AUBAGIO from your body. 
In either case it should be confirmed by a blood test that the active substance has been sufficiently removed 
from your body and you need confirmation from your treating physician that the blood level of AUBAGIO is 
low enough to allow you to become pregnant. 
 
For further information on the laboratory testing please contact your doctor. 
 
If you suspect that you are pregnant while taking AUBAGIO or in the two years after you have stopped 
treatment, you must contact your doctor immediately for a pregnancy test. If the test confirms that you are 
pregnant, your doctor may suggest treatment with certain medicines to remove AUBAGIO rapidly and 
sufficiently from your body, as this may decrease the risk to your baby. 
 
Contraception 
You must use an effective method of contraception during and after treatment with AUBAGIO. 
Teriflunomide remains in your blood for a long time after you stop taking it. Continue to use effective 
contraception after you stop treatment. 
•  Do this until the levels of AUBAGIO in your blood are low enough - your doctor will check this. 
•  Talk with your doctor about the best method of contraception for you and any potential need for 

contraception change. 
 
Do not take AUBAGIO when you are breast-feeding, as teriflunomide passes into the breast milk. 
 
Driving and using machines 
AUBAGIO might make you feel dizzy which may impair your ability to concentrate and react. If you are 
affected, do not drive or use machines. 
 
AUBAGIO contains lactose 
AUBAGIO contains lactose (a type of sugar). If you have been told by your doctor that you have an 
intolerance to some sugars, contact your doctor before taking this medicine. 
 
 
3. How to take AUBAGIO  
 
Treatment with AUBAGIO will be overseen by a doctor who is experienced in the treatment of multiple 
sclerosis. 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. 
 



 

38 

The recommended dose is one film-coated tablet (14 mg) daily.  
 
Route/method of administration 
AUBAGIO is for oral use. AUBAGIO is taken every day as a single daily dose at any time of the day.  
You should swallow the tablet whole with some water. 
AUBAGIO may be taken with or without food. 
 
If you take more AUBAGIO than you should 
If you have taken too much AUBAGIO, call your doctor straight away. You may experience side effects 
similar to those described in section 4 below. 
 
If you forget to take AUBAGIO  
Do not take a double dose to make up for a forgotten tablet. Take your next dose at the scheduled time. 
 
If you stop taking AUBAGIO  
Do not stop taking AUBAGIO or change your dose without talking to your doctor first. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.  
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
The following side effects may happen with this medicine. 
 
Serious side effects 
Tell your doctor immediately, if you notice any of the following serious side effects: 
- allergic reactions which might include symptoms of rash, hives, swelling of lips, tongue or face or 

sudden difficulty breathing.  
- severe skin reactions which might include symptoms of skin rash, blistering, or ulcers in your mouth 
- severe infections or sepsis (a potentially life-threatening type of infection) which might include 

symptoms of high fever, shaking, chills, reduced urine flow, or confusion 
- serious liver disease which might include symptoms of yellowing of your skin or the whites of your 

eyes, darker urine than normal, unexplained nausea and vomiting, or abdominal pain 
- inflammation of the lungs which might include symptoms of shortness of breath or persistent cough 
- inflammation of the pancreas which might include symptoms of severe pain in the upper abdominal 

area that may also be felt in your back, nausea, or vomiting 
 
Other side effects can occur with the following frequencies: 
Very common (may affect more than 1 in 10 people) 
- Headache 
- Diarrhoea, feeling sick 
- Increase in ALT (increase in blood levels of certain hepatic enzymes) shown in tests 
- Hair thinning 
 
Common (may affect up to 1 in 10 people) 
- Influenza, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and 

discomfort when swallowing, cystitis, gastroenteritis viral, oral herpes, tooth infection, laryngitis, 
fungal infection of the foot 

- Laboratory values: a decrease in the number of red blood cells (anaemia), changes in liver and white 
blood cell test results (see section 2), as well as elevations in a muscle enzyme (creatine 
phosphokinase) have been observed. 

- Mild allergic reactions 
- Feeling anxious 
- Pins and needles, feeling weak, numb, tingling or pain in the lower back or leg (sciatica); feeling 

numb, burning, tingling or pain in the hands and fingers (carpal tunnel syndrome) 



 

39 

- Feeling your heartbeat 
- Increase in blood pressure 
- Being sick (vomiting), toothache, upper abdominal pain  
- Rash, acne 
- Pain of the tendons, joints, bones, muscle pain (musculoskeletal pain), 
- Needing to urinate more often than usual 
- Heavy periods 
- Pain 
- Lack of energy or feeling weak (asthenia) 
- Weight loss 
 
Uncommon (may affect up to 1 in 100 people) 
- Decrease in the number of blood platelets (mild thrombocytopenia) 
- Increased feeling or sensitivity, especially in the skin; stabbing or throbbing pain along one or more 

nerves, problems in the nerves of the arms or legs (peripheral neuropathy) 
- Nail disorders 
- Post-traumatic pain 
 
Not known (frequency cannot be estimated from the available data)  
- Severe infections (including sepsis)  
- Severe allergic reactions (including anaphylaxis) 
- Pulmonary reaction (interstitial lung disease, ILD) 
- Inflammation of the liver, pancreas, or mouth/lips 
- Severe skin reactions 
- Abnormal levels of fats (lipids) in the blood 
- Psoriasis 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed 
in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix 
V. By reporting side effects you can help provide more information on the safety of this medicine. 
 
 
5. How to store AUBAGIO  
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton, protective sleeve, and wallet 
after “EXP”. The expiry date refers to the last day of that month. 
 
This medicine does not require any special storage conditions. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw 
away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What AUBAGIO contains  
- The active substance is teriflunomide. Each tablet contains 14 mg of teriflunomide.  
- The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, sodium starch 

glycolate (Type A), hydroxypropylcellulose, magnesium stearate, hypromellose, titanium dioxide 
(E171), talc, macrogol 8000, indigo carmine aluminum lake (E132).  

 
What AUBAGIO looks like and contents of the pack 
AUBAGIO 14 mg film-coated tablets (tablets) are pale blue to pastel blue, pentagonal film-coated tablets 
with imprint on one side (‘14’) and engraved with a corporate logo on the other side. 



 

40 

 
AUBAGIO is available in cardboard cartons containing: 
- 14, 28, 84 and 98 tablets in wallet packs with integrated aluminium blisters; 
- 10x1 tablet in all aluminium perforated unit-dose blisters. 
 
Not all pack sizes may be marketed. 
 
 
Marketing Authorisation Holder 
sanofi-aventis groupe 
54, rue La Boétie  
F-75008 Paris 
France  
 
Manufacturer 
Sanofi Winthrop Industrie 
56, route de Choisy au Bac 
60205 Compiègne 
France 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Sanofi Belgium 
Tel/Tél/Tel: +32 (0)2 710 54 00 
 

Lietuva 
UAB „SANOFI-AVENTIS LIETUVA“ 
Tel: +370 5 2755224 
 

България 
SANOFI BULGARIA EOOD  
Tел: +359 2 970 53 00 
 

Luxembourg/Luxemburg 
Sanofi Belgium  
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien) 
 

Česká republika 
sanofi-aventis, s.r.o. 
Tel: +420 233 086 111 
 

Magyarország 
SANOFI-AVENTIS Zrt. 
 Tel: +36 1 505 0050 
 

Danmark 
Sanofi A/S 
Tlf: +45 45 16 70 00 
 

Malta 
Sanofi S.p.A 
Tel: +39 02 39394275 

Deutschland 
Sanofi-Aventis Deutschland GmbH 
Tel.: 0800 04 36 996 
Tel. aus dem Ausland: +49 69 305 70 13 
 

Nederland 
Genzyme Europe B.V. 
Tel: +31 20 245 4000 

Eesti 
sanofi-aventis Estonia OÜ 
Tel: +372 627 34 88 
 

Norge 
sanofi-aventis Norge AS 
Tlf: +47 67 10 71 00 
 

Ελλάδα 
sanofi-aventis AEBE 
Τηλ: +30 210 900 16 00 
 

Österreich 
sanofi-aventis GmbH 
Tel: +43 1 80 185 – 0 
 

España 
sanofi-aventis S.A. 
Tel: +34 93 485 94 00 

Polska 
sanofi-aventis Sp. z o.o.  
Tel: +48 22 280 00 00 

 
France 

 
Portugal 



41 

Sanofi - Produtos Farmacêuticos, Lda 
Tel: +351 21 35 89 400 

România 
Sanofi Romania SRL 
Tel: +40 (0) 21 317 31 36 

Slovenija 
sanofi-aventis d.o.o. 
Tel: +386 1 560 48 00 

Slovenská republika 
sanofi-aventis Pharma Slovakia s.r.o. 
Tel: +421 2 33 100 100 

Suomi/Finland 
Sanofi Oy 
Puh/Tel: +358 (0) 201 200 300 

Sverige 
Sanofi AB  
Tel: +46 (0) 8 634 5000 

sanofi-aventis France 
Tél: 0 800 222 555 
Appel depuis l’étranger: +33 1 57 63 23 23 

Hrvatska 
sanofi-aventis Croatia d.o.o. 
Tel: +385 1 600 34 00 

Ireland 
sanofi-aventis Ireland Ltd. T/A SANOFI 
Tel: +353 (0) 1 403 56 00 

Ísland 
Vistor hf. 
Sími: +354 535 7000 

Italia 
Sanofi S.p.A. 
Tel:  800536389 

Κύπρος 
sanofi-aventis Cyprus Ltd. 
Τηλ: +357 22 871600 

Latvia 
sanofi-aventis Latvia SIA 
Tel: +371 67 33 24 51 

United Kingdom 
Sanofi  
Tel +44 (0)845 372 7101 

This leaflet was last revised in  

Other sources of information 

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.  


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USEOF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
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{'Title': '2. what you need to know before you take aubagio', 'Section_Content': "do not take aubagio: - if you are allergic to teriflunomide or any of the other ingredients of this medicine (listed in section 6), - if you have severe liver problems, - if you are pregnant, think you may be pregnant, or are breast-feeding, - if you suffer from a serious problem which affects your immune system e.g. acquired immunodeficiency syndrome (aids), - if you have a serious problem with your bone marrow, or if you have low numbers of red or white cells in your blood or a reduced number of blood platelets, - if you are suffering from a serious infection, - if you have severe kidney problems which require dialysis, - if you have very low levels of proteins in your blood (hypoproteinaemia), if you are not sure, talk to your doctor or pharmacist before taking this medicine. warnings and precautions talk to your doctor or pharmacist before taking aubagio if: - you have liver problems and/or if you drink large amounts of alcohol. your doctor will carry out blood tests before and during treatment to check how well your liver is working. if your test results show a problem with your liver, your doctor may stop your treatment with aubagio. please read section 4. - you have high blood pressure (hypertension) whether it is controlled with medicines or not. aubagio can cause an increase in blood pressure. your doctor will check your blood pressure before the start of treatment and regularly thereafter. please read section 4. - you have an infection. before you take aubagio, your doctor will make sure you have enough white blood cells and platelets in your blood. as aubagio decreases the number of white cells in the blood this may affect your ability to fight the infection. your doctor may do blood tests to check your white blood cells if you think you have an infection. please read section 4. - you have severe skin reactions. - you have respiratory symptoms. - you have weakness, numbness and pain in the hands and feet. - you are going to have a vaccination. - you take leflunomide with aubagio. - you are switching to or from aubagio. - you are lactose intolerant. - you are due to have a specific blood test (calcium level). falsely low levels of calcium can be detected. children and adolescents aubagio should not be used in children and adolescents under 18 years of age. this is because the effects of the medicine in this age group are not known. other medicines and aubagio tell your your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. this includes medicines obtained without a prescription. in particular, tell your doctor or pharmacist if you are taking any of the following: - leflunomide, methotrexate and other medicines that affect the immune system (often called immunosuppressants or immunomodulators) - rifampicin (a medicine used to treat tuberculosis and other infections) - carbamazepine, phenobarbital, phenytoin for epilepsy - st john's wort (a herbal medicine for depression) - repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes - daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer - duloxetine for depression, urinary incontinenece or in kidney disease in diabetics - alosetron for the management of severe diarrhea - theophylline for asthma - tizanidine, a muscle relaxant - warfarin, an anticoagulant used to make the blood thinner (i.e. more fluid) in order to avoid blood clots - oral contraceptives (containing ethinylestradiol and levonorgestrel) 37 - cefaclor, benzylpenicillin (penicillin g), ciprofloxacin for infections - indometacin, ketoprofen for pain or inflammation - furosemide for heart disease - cimetidine for reducing gastric acid - zidovudine for hiv infection - rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol) - sulfasalazine for inflammatory bowel disease or rheumatoid arthritis - cholestyramine for high cholesterol or relief from itching in liver disease - activated charcoal to reduce absorption of medicines or other substances pregnancy and breast-feeding do not take aubagio if you are, or think you may be pregnant. if you are pregnant or become pregnant while taking aubagio, the risk of having a baby with birth defects is increased. women of childbearing potential must not take this medicine without using reliable contraceptive measures. tell your doctor if you plan to become pregnant after stopping treatment with aubagio, as you need to ensure that most of this medicine has left your body before trying to become pregnant. the elimination of the active substance may take up to 2 years to occur naturally. the time can be reduced to a few weeks by taking certain medicines which speed up removal of aubagio from your body. in either case it should be confirmed by a blood test that the active substance has been sufficiently removed from your body and you need confirmation from your treating physician that the blood level of aubagio is low enough to allow you to become pregnant. for further information on the laboratory testing please contact your doctor. if you suspect that you are pregnant while taking aubagio or in the two years after you have stopped treatment, you must contact your doctor immediately for a pregnancy test. if the test confirms that you are pregnant, your doctor may suggest treatment with certain medicines to remove aubagio rapidly and sufficiently from your body, as this may decrease the risk to your baby. contraception you must use an effective method of contraception during and after treatment with aubagio. teriflunomide remains in your blood for a long time after you stop taking it. continue to use effective contraception after you stop treatment. do this until the levels of aubagio in your blood are low enough - your doctor will check this. talk with your doctor about the best method of contraception for you and any potential need for contraception change. do not take aubagio when you are breast-feeding, as teriflunomide passes into the breast milk. driving and using machines aubagio might make you feel dizzy which may impair your ability to concentrate and react. if you are affected, do not drive or use machines. aubagio contains lactose aubagio contains lactose (a type of sugar). if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.", 'Entity_Recognition': [{'Text': 'aubagio', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 9, 'BeginOffset': 12, 'EndOffset': 19, 'Score': 0.2228769212961197, 'Text': 'aubagio', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Text': 'allergic', 'Type': 'PROBLEM', 'BeginOffset': 34, 'EndOffset': 42}, {'Id': 10, 'BeginOffset': 46, 'EndOffset': 59, 'Score': 0.9757785201072693, 'Text': 'teriflunomide', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 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{'Title': '3. how to take aubagio', 'Section_Content': 'treatment with aubagio will be overseen by a doctor who is experienced in the treatment of multiple sclerosis. always take this medicine exactly as your doctor has told you. check with your doctor if you are not sure. the recommended dose is one film-coated tablet (14 mg) daily. route/method of administration aubagio is for oral use. aubagio is taken every day as a single daily dose at any time of the day. you should swallow the tablet whole with some water. aubagio may be taken with or without food. if you take more aubagio than you should if you have taken too much aubagio, call your doctor straight away. you may experience side effects similar to those described in section 4 below. if you forget to take aubagio do not take a double dose to make up for a forgotten tablet. take your next dose at the scheduled time. if you stop taking aubagio do not stop taking aubagio or change your dose without talking to your doctor first. if you have any further questions on the use of this medicine, ask your doctor or pharmacist.', 'Entity_Recognition': [{'Text': 'aubagio', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'treatment', 'Type': 'TREATMENT', 'BeginOffset': 0, 'EndOffset': 9}, {'Text': 'aubagio', 'Type': 'TREATMENT', 'BeginOffset': 15, 'EndOffset': 22}, {'Id': 13, 'BeginOffset': 91, 'EndOffset': 109, 'Score': 0.6279972195625305, 'Text': 'multiple sclerosis', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.9322686195373535}]}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 123, 'EndOffset': 136}, {'Text': 'administration aubagio', 'Type': 'TREATMENT', 'BeginOffset': 296, 'EndOffset': 318}, {'Id': 6, 'BeginOffset': 336, 'EndOffset': 343, 'Score': 0.6671432852745056, 'Text': 'aubagio', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': [], 'Attributes': [{'Type': 'ROUTE_OR_MODE', 'Score': 0.45030656456947327, 'RelationshipScore': 0.6396814584732056, 'RelationshipType': 'ROUTE_OR_MODE', 'Id': 5, 'BeginOffset': 326, 'EndOffset': 330, 'Text': 'oral', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'FREQUENCY', 'Score': 0.9137939810752869, 'RelationshipScore': 0.9998714923858643, 'RelationshipType': 'FREQUENCY', 'Id': 7, 'BeginOffset': 353, 'EndOffset': 362, 'Text': 'every day', 'Category': 'MEDICATION', 'Traits': []}]}, {'Id': 8, 'BeginOffset': 463, 'EndOffset': 470, 'Score': 0.3003304898738861, 'Text': 'aubagio', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Id': 9, 'BeginOffset': 523, 'EndOffset': 530, 'Score': 0.29303693771362305, 'Text': 'aubagio', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Id': 14, 'BeginOffset': 634, 'EndOffset': 646, 'Score': 0.8728048801422119, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.6742354035377502}, {'Name': 'DIAGNOSIS', 'Score': 0.420308381319046}]}, {'Text': '4', 'Type': 'NUMBER', 'BeginOffset': 685, 'EndOffset': 686}, {'Id': 10, 'BeginOffset': 716, 'EndOffset': 723, 'Score': 0.4815412759780884, 'Text': 'aubagio', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Text': 'a double dose', 'Type': 'TREATMENT', 'BeginOffset': 736, 'EndOffset': 749}, {'Id': 11, 'BeginOffset': 847, 'EndOffset': 854, 'Score': 0.6332060694694519, 'Text': 'aubagio', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Id': 12, 'BeginOffset': 874, 'EndOffset': 881, 'Score': 0.6556571125984192, 'Text': 'aubagio', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': [{'Name': 'NEGATION', 'Score': 0.44097334146499634}]}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 988, 'EndOffset': 1001}]}
{'Title': '4. possible side effects', 'Section_Content': 'like all medicines, this medicine can cause side effects, although not everybody gets them. the following side effects may happen with this medicine. serious side effects tell your doctor immediately, if you notice any of the following serious side effects: - allergic reactions which might include symptoms of rash, hives, swelling of lips, tongue or face or sudden difficulty breathing. - severe skin reactions which might include symptoms of skin rash, blistering, or ulcers in your mouth - severe infections or sepsis (a potentially life-threatening type of infection) which might include symptoms of high fever, shaking, chills, reduced urine flow, or confusion - serious liver disease which might include symptoms of yellowing of your skin or the whites of your eyes, darker urine than normal, unexplained nausea and vomiting, or abdominal pain - inflammation of the lungs which might include symptoms of shortness of breath or persistent cough - inflammation of the pancreas which might include symptoms of severe pain in the upper abdominal area that may also be felt in your back, nausea, or vomiting other side effects can occur with the following frequencies: very common (may affect more than 1 in 10 people) - headache - diarrhoea, feeling sick - increase in alt (increase in blood levels of certain hepatic enzymes) shown in tests - hair thinning common (may affect up to 1 in 10 people) - influenza, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and discomfort when swallowing, cystitis, gastroenteritis viral, oral herpes, tooth infection, laryngitis, fungal infection of the foot - laboratory values: a decrease in the number of red blood cells (anaemia), changes in liver and white blood cell test results (see section 2), as well as elevations in a muscle enzyme (creatine phosphokinase) have been observed. - mild allergic reactions - feeling anxious - pins and needles, feeling weak, numb, tingling or pain in the lower back or leg (sciatica); feeling numb, burning, tingling or pain in the hands and fingers (carpal tunnel syndrome) 39 - feeling your heartbeat - increase in blood pressure - being sick (vomiting), toothache, upper abdominal pain - rash, acne - pain of the tendons, joints, bones, muscle pain (musculoskeletal pain), - needing to urinate more often than usual - heavy periods - pain - lack of energy or feeling weak (asthenia) - weight loss uncommon (may affect up to 1 in 100 people) - decrease in the number of blood platelets (mild thrombocytopenia) - increased feeling or sensitivity, especially in the skin; stabbing or throbbing pain along one or more nerves, problems in the nerves of the arms or legs (peripheral neuropathy) - nail disorders - post-traumatic pain not known (frequency cannot be estimated from the available data) - severe infections (including sepsis) - severe allergic reactions (including anaphylaxis) - pulmonary reaction (interstitial lung disease, ild) - inflammation of the liver, pancreas, or mouth/lips - severe skin reactions - abnormal levels of fats (lipids) in the blood - psoriasis reporting of side effects if you get any side effects, talk to your doctor or pharmacist. this includes any possible side effects not listed in this leaflet. you can also report side effects directly via the national reporting system listed in appendix v. by reporting side effects you can help provide more information on the safety of this medicine.', 'Entity_Recognition': [{'Text': 'aubagio', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'all medicines', 'Type': 'TREATMENT', 'BeginOffset': 5, 'EndOffset': 18}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 20, 'EndOffset': 33}, {'Id': 26, 'BeginOffset': 44, 'EndOffset': 56, 'Score': 0.9669947624206543, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 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{'Title': '5. how to store aubagio', 'Section_Content': 'keep this medicine out of the sight and reach of children. do not use this medicine after the expiry date which is stated on the carton, protective sleeve, and wallet after "exp". the expiry date refers to the last day of that month. this medicine does not require any special storage conditions. do not throw away any medicines via wastewater or household waste. ask your pharmacist how to throw away medicines you no longer use. these measures will help protect the environment.', 'Entity_Recognition': [{'Text': 'aubagio', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 70, 'EndOffset': 83}, {'Text': 'protective sleeve', 'Type': 'TREATMENT', 'BeginOffset': 137, 'EndOffset': 154}]}
{'Title': '6. contents of the pack and other information', 'Section_Content': "what aubagio contains - the active substance is teriflunomide. each tablet contains 14 mg of teriflunomide. - the other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, sodium starch glycolate (type a), hydroxypropylcellulose, magnesium stearate, hypromellose, titanium dioxide (e171), talc, macrogol 8000, indigo carmine aluminum lake (e132). what aubagio looks like and contents of the pack aubagio 14 mg film-coated tablets (tablets) are pale blue to pastel blue, pentagonal film-coated tablets with imprint on one side ('14') and engraved with a corporate logo on the other side. aubagio is available in cardboard cartons containing: - 14, 28, 84 and 98 tablets in wallet packs with integrated aluminium blisters; - 10x1 tablet in all aluminium perforated unit-dose blisters. not all pack sizes may be marketed.", 'Entity_Recognition': [{'Text': 'aubagio', 'Type': 'PRODUCT_NAME', 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