Aubagio

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

Aubagio contains the active ingredient teriflunomide. Aubagio is used to treat relapsing forms of multiple sclerosis (MS).
For more information, see Section 1. Why am I using Aubagio? in the full CMI.

Do not use if you have ever had an allergic reaction to teriflunomide, leflunomide or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Aubagio? in the full CMI.

Some medicines may interfere with Aubagio and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

More instructions can be found in Section 4. How do I use Aubagio? in the full CMI.

For more information, see Section 5. What should I know while using Aubagio? in the full CMI.

Less serious side effects include diarrhoea; rashes, itchy skin; hair loss; weight loss; unusual tiredness or weakness; numbness or tingling of hands or feet; thickened, inflamed, red patches on the skin, which may be accompanied with whitish scaly skin, or accompanied by white pus-filled bumps. More serious side effects include signs and symptoms of severe infection e.g fever; severe upper stomach pain, often with nausea and vomiting; severe skin rash or sores in your mouth; skin becoming pale, you start to feel tired, you become prone to infections or bruising; new or worsening symptoms such as cough or trouble breathing, with or without a fever; allergic reaction such as swelling of the face, lips, mouth or throat, which may cause difficulty in swallowing or breathing, hives, fainting, yellowing of the skin and eyes (jaundice), thickened patches of red skin.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Active ingredient(s): Teriflunomide

This leaflet provides important information about using Aubagio. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Aubagio.

Where to find information in this leaflet:

Aubagio contains the active ingredient teriflunomide.

Aubagio is used to treat relapsing forms of multiple sclerosis (MS).

The cause of MS is not yet known. MS affects the central nervous system (CNS) - the brain and spinal cord.

In MS, the body's immune system reacts against its own myelin (the 'insulation' or the protective sheath surrounding nerve fibres). With relapsing forms of MS, people can have repeated attacks or relapses of inflammation of the CNS from time to time.

Symptoms vary from patient to patient and may include blurred vision, weakness in the legs or arms, or loss of control of bowel or bladder function. These are followed by periods of recovery.

Aubagio works by selectively interfering with the ability of white blood cells (lymphocytes) to produce the disease response and nerve damage that ultimately leads to relapses.

Aubagio has been shown to reduce or decrease the number of relapses and slow down the progression of physical disability in patients with relapsing forms of MS. Although it is not a cure, patients treated with Aubagio generally find they will have fewer relapses.

Your doctor, however, may have prescribed Aubagio for another purpose.

Ask your doctor if you have any questions about why it has been prescribed for you.

Before you start Aubagio, your doctor will need to take blood samples to check the health of your liver and blood cells. This must be done in the last 6 months before starting this medicine.

Tell your doctor if you plan to have surgery.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

You must not become pregnant while taking Aubagio and for a certain period of time after stopping Aubagio.

Aubagio may increase the risk of birth defects. To reduce any risk to the developing baby, you will need to stop taking Aubagio and may need to undergo a wash-out procedure. Your doctor will discuss the wash-out procedure with you.

Women of childbearing potential must use reliable contraception while taking Aubagio.

Tell your doctor immediately if you think you could be pregnant while taking Aubagio.

Tell your doctor if you intend to become pregnant or father a child.

Do not take it if you are breastfeeding or planning to breastfeed

Aubagio passes into breast milk and there is a serious risk to the baby. You and your doctor will decide what is best for you and your baby.

Do not give Aubagio to a child or adolescent

Aubagio is not approved for use in children or adolescents under 18 years old.

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Aubagio and affect how it works or be affected by Aubagio.

Interactions between Aubagio and other medications include:

You may need to use different amounts of your medicine, or take different medicines. Your doctor or pharmacist will advise you.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Aubagio.

In certain situations, for example, if you experience a serious side effect, you change your medication or you want to fall pregnant, your doctor will ask you to take medication that will help your body get rid of Aubagio faster.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Aubagio.

Aubagio should be used regularly at the same time each day.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

This may increase the chance of you getting an unwanted side effect.

If there is still a long time to go before your next dose, take it as soon as you remember, and then go back to taking it as you would normally.

If you are not sure what to do, ask your doctor or pharmacist.

If you think that you or anyone else may have used too much Aubagio, you may need urgent medical attention.

You should immediately:

You should do this even if there are no signs of discomfort or poisoning.

If you become pregnant while you are taking this medicine, stop taking it and tell your doctor or pharmacist immediately.

If you need to stop treatment, the levels of Aubagio in your blood can be lowered rapidly using a special wash-out procedure.

If you are female talk to your doctor about birth control that you must use during treatment. You must use reliable methods of birth control while taking Aubagio.

Talk to your doctor if you plan to become pregnant or before you stop taking this medicine.

Tell your doctor if you need to have a vaccination during treatment with this medicine or for 6 months after stopping treatment.

Remind any doctor, dentist or pharmacist you visit that you are using Aubagio.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking Aubagio.

Be careful before you drive or use any machines or tools until you know how Aubagio affects you.

Tell your doctor if you drink alcohol.

The effects of alcohol could be made worse while taking Aubagio. It is recommended that you minimise your alcohol intake while taking Aubagio.

Follow the instructions on the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

Keep it where young children cannot reach it.

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems  (Australia) or the Centre for Adverse Reactions Monitoring (CARM) within the New Zealand Pharmacovigilance Centre https://nzphvc.otago.ac.nz/reporting/  (New Zealand).

By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

This medicine is only available with a doctor's prescription.

Do not take this medicine if you are allergic to any of these ingredients.

Aubagio 14 mg tablets are pale blue to pastel blue pentagonal film coated tablets with "14" imprinted on one side and engraved with a logo on the other. Aubagio 14 mg tablets are supplied in blister packs of 10 and 28 tablets.

(AUST R 192672)

Aubagio is supplied in Australia by:

sanofi-aventis australia pty ltd

12-24 Talavera Road

Macquarie Park NSW 2113

Freecall No: 1800 818 806

Aubagio is supplied in New Zealand by:

sanofi -aventis new zealand limited Level 8,

56 Cawley Street Ellerslie

Auckland

Freecall No: 0800 283 684

This leaflet was prepared in February 2022

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