Aubagio (teriflunomide) – Package leaflet - L04AA31

Updated on site: 05-Oct-2017

Medication nameAubagio
ATC CodeL04AA31
ManufacturerSanofi-aventis Groupe  

Package leaflet: Information for the patient

AUBAGIO 14 mg film-coated tablets teriflunomide

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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.

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.

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.

2. What you need to know before you take AUBAGIO

Do not take AUBAGIO:

-if you are allergic to the active substance 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. 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 AUBAGIO.

Warnings and precautions

Talk to your doctor or pharmacist before taking AUBAGIO if:

-you have liver problems; 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 regularly during treatment. Please read section 4.

-you are going to have a vaccination.

-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.

AUBAGIO can occasionally cause some problems with lungs, or nerves in your arms or legs. For more information on these, please read section 4

If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking AUBAGIO.

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)

-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 AUBAGIO 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 AUBAGIO has left your body before trying to become pregnant. This drug elimination 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 AUBAGIO 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.


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, talk to 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.

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 include

Very common side effects (may affect more than 1 in 10 people):


Diarrhoea, feeling sick

Increase in ALT (increase in blood levels of certain hepatic enzymes) shown in tests

Hair thinning

Common side effects (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)

-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


-Weight loss

Uncommon side effects (may affect up to 1 in 100 people):

-Decrease in the number of blood platelets (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)

Not known (frequency cannot be estimated from the available data):

-Nail disorders

-Lack of energy or feeling weak (asthenia)

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.

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 in your country.

Marketing Authorisation Holder sanofi-aventis groupe

54, rue La Boétie

F-75008 Paris



Sanofi Winthrop Industrie 56, route de Choisy au Bac 60205 Compiègne


For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:



Sanofi Belgium


Tel/Tél/Tel: +32 (0)2 710 54 00

Tel: +370 5 2755224



sanofi-aventis Bulgaria EOOD

Sanofi Belgium

Tел: +359 2 9705300

Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika


sanofi-aventis, s.r.o.


Tel: +420 233 086 111

Tel: +36 1 505 0050



sanofi-aventis Denmark A/S

Sanofi Malta Ltd.

Tlf: +45 45 16 70 00

Tel: +356 21493022



Genzyme GmbH

Genzyme Europe B.V.

Tel: 0800-0436996

Tel: +31 35 699 1200

Tel. aus dem Ausland: +49 6102 3674 0




sanofi-aventis Estonia OÜ

sanofi-aventis Norge AS

Tel: +372 627 34 88

Tlf: +47 67 10 71 00



sanofi-aventis AEBE

sanofi-aventis GmbH

Τηλ: +30 210 900 16 00

Tel: +43 1 80 185 – 0



Genzyme, S.L.U.

sanofi-aventis Sp. z o.o.

Tel: +34 93 485 94 00

Tel: +48 22 280 00 00

sanofi-aventis S.A.


Tel: +34 93 485 94 00




Genzyme S.A.S.

Sanofi - Produtos Farmacêuticos, Lda

Information médicale: tél: +33(0) 800 100 499

Tel: +351 21 42 20 100



sanofi-aventis Croatia d.o.o.

Sanofi Romania SRL

Tel: +385 1 600 34 00

Tel: +40 (0) 21 317 31 36



Genzyme Therapeutics Ltd. (United Kingdom)

sanofi-aventis d.o.o.

Tel: +44 (0) 1865 405200

Tel: +386 1 560 48 00


Slovenská republika

Vistor hf.

sanofi-aventis Pharma Slovakia s.r.o.

Sími: +354 535 7000

Tel: +421 2 33 100 100



Genzyme Srl

Sanofi Oy

Tel: +39 059 349 811

Puh/Tel: +358 (0) 201 200 300



sanofi-aventis Cyprus Ltd.

Sanofi AB

Τηλ: +357 22 871600

Tel: +46 (0) 8 634 5000


United Kingdom

sanofi-aventis Latvia SIA

Genzyme Therapeutics Ltd. (United Kingdom)

Tel: +371 67 33 24 51

Tel: +44 (0) 1865 405200

This leaflet was last revised in

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




Scientific conclusions

Taking into account the PRAC Assessment Report on the PSUR(s) for teriflunomide, the scientific conclusions of the CHMP are as follows:

Cumulatively, a total of 39 unique case reports of potential Interstitial lung disease (ILD) were retrieved, of which 3 cases with a possible causal relationship with teriflunomide. Since ILD can be a serious event, possibly fatal, it should be included in section 4.4 of the SmPC as reported in the post-marketing setting and not just as reported for the parent compound leflunomide. Due to the long half-life of the compound recommendation for initiation of an accelerated elimination procedure in case of pulmonary symptoms should also be included. ILD should also be moved from “very rare” to “not known” without a reference to leflunomide in the table in section 4.8.

In the post-marketing setting, 121 hepatic disorders events (26 % of the total) were assessed as associated with teriflunomide. An increase of ALT (≥3 x ULN) in combination with an increase of total bilirubin (>2 x ULN) indicates drug induced liver injury showing that teriflunomide is not only associated with non-serious elevations of liver enzymes, but also with serious hepatic events, like “acute hepatitis” which should be included in the SmPC section 4.8 with a frequency unknown. In addition, the adverse reactions “Alanine aminotransferase (ALT) increase”, “Gamma-glutamyl transferase (GGT) increase” and “Aspartate aminotransferase increase” should be moved from the system organ class (SOC) term “Investigations” to the SOC “Hepatobiliary disorders”.

Based on the very high number of reported post-marketing cases of asthenia (cumulatively 5873 cases) and considering that asthenia is also listed in the SmPC for the parent compound leflunomide, it should be included as possible adverse reaction for teriflunomide in the table in SmPC section 4.8 with a frequency of unknown.

Ten post-marketing cases of nail disorders reported a possible causality with teriflunomide and 6 of them resulted positive for de-challenge. It is also noted that nail loss and other nail disorders were often reported together with hair loss or hair thinning, suggesting a possible shared pathophysiologic mechanism; and alopecia is a known side effect of teriflunomide. Therefore, “nail disorders” should be included in the table in SmPC section 4.8 as possible adverse reaction with a frequency of unknown.

The CHMP agrees with the scientific conclusions made by the PRAC.

Grounds for the variation to the terms of the marketing authorisation(s)

On the basis of the scientific conclusions for teriflunomide the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing teriflunomide is unchanged subject to the proposed changes to the product information.

The CHMP recommends that the terms of the marketing authorisation(s) should be varied.


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