Aubagio

Patient Information Leaflet

AUBAGIO 7 mg film-coated tablets, 14 mg film-coated tablets

teriflunomide
Please read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What AUBAGIO is and what it is used for
2. What you need to know before taking 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 that modulates the immune system to reduce its attacks on the nervous system.
What AUBAGIO is used for
AUBAGIO is used in adults, children, and adolescents (aged 10 years and older) for the treatment of relapsing-remitting multiple sclerosis (MS).
What is multiple sclerosis
MS is a long-term disease affecting the central nervous system (CNS), a system composed of the brain and spinal cord. In multiple sclerosis, inflammation destroys the protective covering (called myelin) that surrounds the nerves of the CNS. This loss of myelin is known as demyelination. It prevents nerves from functioning properly.
People with relapsing forms of multiple sclerosis experience repeated episodes (relapses) of physical symptoms caused by improper nerve function. These symptoms vary from patient to patient but generally include:

• difficulty walking
• vision problems
• balance problems

Symptoms may completely disappear after a relapse, but over time, some problems may persist between relapses. This can lead to physical disability that may interfere with daily activities.

How AUBAGIO works
AUBAGIO helps protect the central nervous system from immune system attacks by limiting the increase of certain white blood cells (lymphocytes). This reduces the inflammation that causes nerve damage characteristic of MS.

2. What you should know before taking AUBAGIO

Do not take AUBAGIO:

• if you are allergic to teriflunomide or to any of the other ingredients of this medicine (listed in section 6),
• if you have developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking teriflunomide or leflunomide,
• if you have severe liver problems,
• if you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding,
• if you have any serious condition affecting the immune system (e.g. acquired immunodeficiency syndrome (AIDS)),
• if you have any serious bone marrow disorder or have low levels of red blood cells or white blood cells in the blood or a reduced number of platelets,
• if you have a serious infection,
• if you have severe kidney problems requiring dialysis,
• if you have very low levels of protein in the blood (hypoproteinemia). If in doubt, consult 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 consume large amounts of alcohol. Your doctor will request blood tests before and during treatment to monitor liver function. If blood test results show a liver problem, your doctor may ask you to stop treatment with AUBAGIO. See section 4.
• you have high blood pressure (hypertension), whether controlled or not by medication. AUBAGIO may cause an increase in blood pressure. Your doctor will check your blood pressure before starting treatment and regularly thereafter. See section 4.
• you have an infection. Before starting AUBAGIO, your doctor will check that your white blood cell and platelet counts are adequate. Since AUBAGIO reduces the number of white blood cells in the blood, this may affect your ability to fight infections. If you suspect you have an infection, your doctor may perform blood tests to monitor white blood cells. Infections caused by the herpes virus, including oral herpes or herpes zoster (shingles), may occur during treatment with teriflunomide. In some cases, serious complications may develop. You must inform your doctor immediately if you suspect any symptoms of a herpes virus infection. See section 4.
• you have severe skin reactions.
• you have respiratory symptoms.
• you have weakness, numbness, or pain in your hands or feet.
• you need to receive a vaccination.
• you are taking leflunomide together with AUBAGIO.
• you are switching to or from treatment with AUBAGIO. You will need a specific blood test (calcium level). Falsely low calcium levels may be observed.

Respiratory reactions
Inform your doctor if you develop unexplained cough or shortness of breath (dyspnea). Your doctor may perform further evaluations.

Children and adolescents
AUBAGIO is not indicated in children under 10 years of age, as it has not been studied in patients with MS in this age group.
The warnings and precautions listed above also apply to children. The following information is important for children and their caregivers:

• inflammation of the pancreas has been observed in patients taking teriflunomide. Your child’s doctor may perform blood tests if pancreatitis is suspected.

Other medicines and AUBAGIO
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• leflunomide, methotrexate, and other medicines that affect the immune system (commonly 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 incontinence, or kidney problems in diabetics,
• alosetron for management of severe diarrhoea,
• theophylline for asthma,
• tizanidine, a muscle relaxant,
• warfarin, an anticoagulant used to thin the blood (i.e. make it more fluid) to prevent blood clots,
• oral contraceptives (containing ethinylestradiol and levonorgestrel),
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections,
• indometacin, ketoprofen for pain or inflammation,
• furosemide for heart conditions,
• 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,
• colestyramine for high cholesterol or relief of itching in liver diseases,
• activated charcoal to reduce absorption of medicines or other substances.

Pregnancy and breastfeeding
Do not take AUBAGIO if you are pregnant or suspect you may be pregnant. If you become pregnant while taking AUBAGIO, the risk of birth defects in the baby increases. Women of childbearing potential must not take this medicine without using reliable contraceptive measures.
If your daughter begins menstruation while taking AUBAGIO, inform your doctor, who will provide specialist advice regarding contraception and potential risks in case of pregnancy.
Inform your doctor if you plan to become pregnant after stopping treatment with AUBAGIO, because you must ensure that most of the medicine has been eliminated from your body before attempting pregnancy. Elimination of the active substance may take up to 2 years to occur naturally. This period can be reduced to a few weeks by taking certain medicines that accelerate the elimination of AUBAGIO from the body.
In any case, a blood test must confirm that the active substance has been sufficiently eliminated from your body, and you must wait for your doctor’s confirmation that AUBAGIO blood levels are low enough to allow pregnancy.
For further information on laboratory tests, consult your doctor.
If you suspect you are pregnant while taking AUBAGIO or within two years after stopping treatment, you must stop AUBAGIO and contact your doctor immediately for a pregnancy test. If pregnancy is confirmed, your doctor may recommend treatment with certain medicines to rapidly and sufficiently eliminate AUBAGIO from the body, as this may reduce the risk to the fetus.

Contraception
You must use an effective method of contraception during and after treatment with AUBAGIO. Teriflunomide remains in the blood for a long time after stopping treatment. Continue using effective contraception after stopping treatment.

• Continue until AUBAGIO blood levels are sufficiently low. Your doctor will monitor them.
• Discuss with your doctor the most appropriate contraceptive method for you and if any change in contraception is needed.

Do not take AUBAGIO if you are breastfeeding, as teriflunomide passes into breast milk.

Driving and using machines
AUBAGIO may cause dizziness, which could impair your ability to concentrate and react. You should not drive or operate machinery if you experience this symptom.

AUBAGIO contains lactose
AUBAGIO contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

AUBAGIO contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take AUBAGIO

Treatment with AUBAGIO must be supervised by a physician experienced in the management of multiple sclerosis.
Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.
Adults
The recommended dose is one 14 mg tablet per day.
Children and adolescents (aged 10 years or older)
The dose depends on body weight:

• Children with body weight above 40 kg: one 14 mg tablet per day.
• Children with body weight less than or equal to 40 kg: one 7 mg tablet per day.

Children and adolescents who reach a stable body weight above 40 kg will be instructed by their doctor to switch to one 14 mg tablet per day.
Route/method of administration
AUBAGIO is for oral use. AUBAGIO is taken daily as a single daily dose at any time of the day.
The tablet must be swallowed whole with a little water.
AUBAGIO may be taken with or without food.
If you take more AUBAGIO than you should
If you have taken too much AUBAGIO, contact your doctor immediately. You may experience adverse 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 the missed tablet. Take the next dose at the scheduled time.
If you stop taking AUBAGIO
Do not stop using AUBAGIO or change the dose without first talking to your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
The following side effects may occur with this medicine.
Serious side effects
Some side effects may be or may become serious. Contact your doctor immediately if you notice any of the
following serious side effects.
Common (may affect up to 1 in 10 people)

• inflammation of the pancreas, which may include symptoms such as abdominal pain, nausea or vomiting (frequency is common in paediatric patients and uncommon in adult patients).

Uncommon (may affect up to 1 in 100 people)

• allergic reactions which may include symptoms such as rash, hives, swelling of the lips, tongue or face, or sudden breathing difficulties
• severe skin reactions which may include symptoms such as rash, blisters, fever, or mouth ulcers
• severe infections or sepsis (a type of infection that may be life-threatening), which may include symptoms such as high fever, shaking, chills, reduced urine output, or confusion
• inflammation of the lungs which may include symptoms such as shortness of breath or persistent cough

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

• severe liver diseases which may include symptoms such as yellowing of the skin or whites of the eyes, darker than normal urine, unexplained nausea and vomiting, or abdominal pain

Other side effects may occur with the following frequencies
Very common (may affect more than 1 in 10 people):

• Headache
• Diarrhoea, nausea
• Increased ALT (elevated levels of certain liver enzymes in the blood) detected in laboratory 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, viral gastroenteritis, dental infection, laryngitis, fungal foot infection
• Herpes virus infections, including oral herpes and herpes zoster (shingles), with symptoms such as blisters, burning, itching, numbness or pain of the skin, usually on one side of the upper body or face, and other symptoms such as fever and weakness
• Laboratory tests: decreased red blood cell count (anaemia), changes in liver function and white blood cell test results (see section 2), and increases in a muscle enzyme (creatine phosphokinase)
• Mild allergic reactions
• Feeling of anxiety
• Tingling, weakness, numbness, tingling or pain in the lower back or legs (sciatica); numbness, tingling or pain in the hands and fingers (carpal tunnel syndrome)
• Awareness of heartbeat
• Increased blood pressure
• Vomiting, toothache, upper abdominal pain
• Rash, acne
• Tendon, joint, bone pain, muscle pain (musculoskeletal pain)
• Need to urinate more often than usual
• Heavy menstrual periods
• Pain
• Lack of energy or feeling weak (asthenia)
• Weight loss

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

• Decreased platelet count (mild thrombocytopenia)
• Increased sensitivity, particularly of the skin; stabbing or pulsating pain in one or more nerves; nerve problems in arms or legs (peripheral neuropathy)
• Nail disorders, severe skin reactions
• Post-traumatic pain
• Psoriasis
• Inflammation of the mouth/lips
• Abnormal levels of fats (lipids) in the blood
• Inflammation of the colon (colitis)

Rare (may affect up to 1 in 1,000 people):
Inflammation or damage to the liver
Not known (frequency cannot be estimated from the available data):

• Increased blood pressure in the lungs

Children (aged 10 years and older) and adolescents
The side effects listed above also apply to children and adolescents. The following additional information is important for children, adolescents and those caring for them:
Common (may affect up to 1 in 10 people)

• Inflammation of the pancreas

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex 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 stated on the carton and container (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 dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What AUBAGIO Contains
The active substance is teriflunomide.
AUBAGIO 7 mg film-coated tablets

• Each tablet contains 7 mg of teriflunomide. The other ingredients are monohydrate lactose, maize starch, microcrystalline cellulose, sodium starch glycolate (type A), hydroxypropylcellulose, magnesium stearate, hypromellose, titanium dioxide (E171), talc, macrogol 8000, indigo carmine – aluminium lake (E132) and yellow iron oxide (E172) (see section 2 “Aubagio contains lactose”).

AUBAGIO 14 mg film-coated tablets

• Each tablet contains 14 mg of teriflunomide.
• The other ingredients are monohydrate lactose, maize starch, microcrystalline cellul游戏副本