Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using Aubagio?
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.
2. What should I know before I use Aubagio?
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.
3. What if I am taking other medicines?
4. How do I use Aubagio?
Follow all directions given to you by your doctor and pharmacist carefully. The usual
dose for this medicine is one 14 mg tablet per day. Swallow the tablet whole with
a glass of water.
5. What should I know while using Aubagio?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Aubagio.
If you become pregnant while you are taking this medicine, stop taking it and tell
your doctor or pharmacist immediately.
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|
Things you should not do
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Do not stop taking Aubagio, or lower the dose, without checking with your doctor.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how Aubagio
affects you.
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Drinking alcohol
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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.
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Looking after your medicine
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Keep the medicine in a cool dry place where the temperature stays below 30°C.
Keep your tablets in the container until it is time to take them.
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6. Are there any side effects?
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.
Active ingredient(s): Teriflunomide
Full Consumer Medicine Information (CMI)
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:
1. Why am I using Aubagio?
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.
2. What should I know before I use Aubagio?
Warnings
Do not use Aubagio if:
you are allergic to teriflunomide, leflunomide or any of the ingredients listed at
the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
have any diseases which reduce your body's natural defences
have any diseases of the blood
have, or have had any serious skin disorders such as rash with blisters and peeling
of the skin or extended rashes with the liver, blood and other body organs involvement
have severe liver disease
have a condition called hypoproteinaemia (when you do not have enough protein in your
blood)
are pregnant or plan to become pregnant
are not using reliable birth control
are breastfeeding
Check with your doctor if you:
intend to become pregnant or father a child.
have any other medical conditions especially the following: Liver problems, high blood
pressure, chronic or serious infection, a decrease in the number of white blood cells
or an illness which lowered your body's resistance to disease, tuberculosis, lung
problems, such as interstitial lung disease (an inflammation of lung tissue) which
is a serious and potentially fatal disease, or kidney disease
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?
Pregnancy and breastfeeding
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.
Children and adolescents
Do not give Aubagio to a child or adolescent
Aubagio is not approved for use in children or adolescents under 18 years old.
3. What if I am taking other medicines?
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:
Some antibiotics such as rifampicin, cefaclor, penicillin G and ciprofloxacin
Some medicines used to treat epilepsy such as carbamazepine and phenytoin
Some medicines used for diabetes such as repaglinide or pioglitazone
Some medicines to treat cancer such as paclitaxel, doxorubicin, methotrexate
Some medicines used to treat depression such as duloxetine
Ondansetron, a medicine used to prevent and treat nausea
Theophylline, a medicine used to prevent asthma
Warfarin, a medicine used to prevent blood clots
Some medicines used to lower cholesterol such as “statins” - rosuvastatin
St John's Wort
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.
4. How do I use Aubagio?
How much to take
The usual dose for this medicine is one 14 mg tablet per day.
Your doctor may have prescribed a different dose.
Ask your doctor or pharmacist if you are unsure of the correct dose for you. They
will tell you exactly how much to take.
Follow the instructions they give you. These directions may differ from the information
contained in this leaflet. If you take the wrong dose, Aubagio may not work as well.
Continue taking your medicine for as long as your doctor or pharmacist tells you.
The medicine helps control your condition, but it does not cure it. Therefore, you
must take it every day.
When to take Aubagio
Aubagio should be taken at about the same time every day. Taking your tablets at the
same time each day will have the best effect. It will also help you to remember when
to take the tablets.
It does not matter if you take Aubagio before or after food
How to take Aubagio
Swallow the tablet whole with a full glass of water.
If you forget to use 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 use too much Aubagio
If you think that you or anyone else may have used too much Aubagio, you may need
urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26 in Australia), or
(by calling
0800 764 766 in New Zealand), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using Aubagio?
Things you should do
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.
Call your doctor straight away if you:
have an infection or notice chills or a fever or signs of an infection while taking
this medicine
your skin becomes itchy or yellow, the whites of your eyes become yellow, you start
to bleed or bruise easily, or your urine becomes very dark or you have stomach pain,
nausea or vomiting, stop taking it immediately. You may be developing a liver problem
experience numbness or tingling in the hands or feet or numbness or weakness of the
arms and legs
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.
Things you should not do
Do not take more than the recommended dose unless your doctor tells you to.
Do not give this medicine to anyone else, even if they have the same condition as
you.
Do not use this medicine to treat any other complaints unless your doctor tells you
to.
Do not stop taking Aubagio, or lower the dose, without checking with your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Aubagio
affects you.
Drinking alcohol
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.
Looking after your medicine
Keep the medicine in a cool dry place where the temperature stays below 30°C.
Keep your tablets in the container until it is time to take them.
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:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
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.
6. Are there any side effects?
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.
Less serious side effects
Serious 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.
Reporting side effects
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.
7. Product details
This medicine is only available with a doctor's prescription.
What Aubagio contains
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Active ingredient
(main ingredient)
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Teriflunomide 14 mg
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Other ingredients
(inactive ingredients)
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Lactose monohydrate
Maize starch
Hyprolose
Microcrystalline cellulose
Sodium starch glycollate
Magnesium stearate
Hypromellose
Macrogol 8000
Purified talc and titanium dioxide
Indigo carmine aluminium lake
OPADRY complete film coating system 03F20651 BLUE
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Potential allergens
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Lactose monohydrate
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Do not take this medicine if you are allergic to any of these ingredients.
What Aubagio looks like
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)
Who distributes Aubagio
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
aubagio-ccdsv9-cmiv8-07feb22