Download Aubagio - North Bristol NHS Trust

Teriflunomide (Aubagio)
14mg once daily tablet
Exceptional healthcare, personally delivered
Your Consultant Neurologist has suggested that you may benefit
from treatment with Teriflunomide.
The decision to start this form of treatment can be difficult.
Therefore, this leaflet gives you some information about
Teriflunomide. Your Consultant Neurologist, Speciality Doctor or
MS Specialist Nurse may be able to answer any further questions
you may have.
What is Teriflunomide?
Teriflunomide is a tablet which is given to try and reduce the
frequency of MS relapses. We hope that this may reduce the
chance of accumulating disability over time (years). However,
although clinical trials have shown Teriflunomide reduces relapse
rates, it is still unknown as to whether or not it will make a
significant impact on your level of disability over the long term.
Normally our immune system defends our bodies against
infection. In MS is it believed that the immune system mistakenly
identifies the body’s nerve tissue in the brain and spinal cord
as a foreign intruder and attacks it. This causes damage to the
protective coating (called myelin), which surrounds the nerves
and can lead to scarring (sclerosis) of the tissue. This causes
disruption of the messages that are sent via the brain and spinal
cord and can cause a variety of symptoms.
Teriflunomide 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.
How is Teriflunomide taken?
Teriflunomide is a once daily, oral tablet which can be taken at
any time of the day, though we would recommend that it is
taken at roughly the same time each day. It can be taken with or
without food.
2
Teriflunomide (Aubagio) 14mg once daily tablet
Things your Consultant needs to know
Medications
Before starting any new medication it is important that you
inform your consultant of all the medication you are taking,
both prescribed and bought ‘over the counter’. This will
include any recreational medications. This is so your consultant
can ensure that your medication does not interact with
Teriflunomide. If you do begin taking Teriflunomide you should
also check with your GP, MS team or pharmacist for interactions
with any new medication you are prescribed before taking it.
In addition other immunosuppressant or immunomodulating
medications should be avoided.
Infection
It is important to inform your Consultant if you have any
infections. We will be required to check your blood prior to
initiating treatment this is to ensure you have enough white
blood cells and platelets prior to starting Teriflunomide. This is
because Teriflunomide decreases the number of white cells in
the blood which may lead to difficulty fighting infection. It may
be necessary to delay/stop treatment until the infection has
resolved.
Other Health ProblemsPrior to starting treatment your
consultant will wish to ensure the drug is suitable for you.
You will need to inform your consultant of any other health
conditions you may have or have had previously. In particular
it is important to inform your specialist if you have or are
suffering from liver disease.
Teriflunomide (Aubagio) 14mg once daily tablet
3
Pregnancy or breast feeding
It is very important that you do not take Teriflunomide if you are
trying to conceive, pregnant, or think you may be pregnant. If you
are pregnant or become pregnant whilst taking Teriflunomide, the
risk of having a baby with birth defects is believed to be increased.
Therefore if you suspect you are pregnant whilst taking
Teriflunomide or in the two years after you have stopped
treatment, you must contact your doctor immediately.
It is also important to tell your doctor if you plan to become
pregnant after stopping treatment. It can take a long time for the
effects of Teriflunomide to be naturally removed from your body.
It is therefore advised that woman should not try to conceive for
TWO years after stopping Teriflunomide.
However there are medications that can be given once
Teriflunomide is stopped that accelerate the removal of this
medication allowing safe pregnancy earlier. Blood tests will need
to be performed after such accelerated elimination.
Do not take Teriflunomide if you are breast feeding, as
Teriflunomide passes on through the breast milk.
Contraception
Woman of childbearing potential must use an effective method
of contraception during two years after stopping treatment
with Teriflunomide. Talk to your GP about the best methods of
contraception for you.
The effects of teriflunomide on male fertility continue to be
evaluated but, to date, there is no evidence to restrict its use in
men who wish to father a child.
Lactose
Teriflunomide contains lactose. If you think you maybe intolerant
to some sugars please discuss this with your GP prior to taking this
medication.
4
Teriflunomide (Aubagio) 14mg once daily tablet
What tests will I need before I can start
Teriflunomide?
Prior to starting Teriflunomide we will need to perform some
tests. These will include:
nn Blood and urine test including a pregnancy test (if
applicable)
nn A recording of your blood pressure
What test will need to be done once I
commence Teriflunomide?
You will be required to attend a health facility for monitoring
of your blood every 2 weeks for the first 6 months and
every 8 weeks thereafter. It is very important to attend these
appointments, failing to do so could cause you harm and may
result in our being able to continue your prescriptions.
You blood pressure will be monitored at regular intervals whilst
you are on treatment.
Possible side effects
Like all medicines, this medicine can cause side effects, although
according to large trials with MS patients these appear to be
largely infrequent. The following side effects may happen with
this medicine.
Serious side effects
Tell your GP or MS Nurse straight away, if you notice any
of the following serious side effects:
nn Jaundice, yellowing of your skin or the whites of your
eyes, darker urine than normal or unexplained nausea and
vomiting - these may be signs of a liver problem and you
will need to have a blood test.
Teriflunomide (Aubagio) 14mg once daily tablet
5
nn Infection – this may include ’flu (fever or ‘flu like’
symptoms); sinus or throat infection; urinary tract infection
or cystitis; bronchitis; diarrhoea or being sick; cold sores;
tooth infection; laryngitis or fungal foot infection.
Other side effects include:
Very common side effects (may effect more than 1 in 10
people):
nn Upper respiratory tract infection, urinary tract infection
nn Pins and needles
nn Diarrhoea, feeling sick
nn Increase in ALT ( increase in blood levels of certain liver
enzymes) shown in your regular blood tests. This typically
reverses when the drug is stopped.
nn Hair thinning, this is reported as being transient and usually
occurs within the first six months.
Common side effects (may effect up to 1 in 10 people):
nn Bronchitis, sinusitis, sore throat and discomfort when
swallowing, cystitis, gastroenteritis viral, oral herpes, tooth
infection, laryngitis, fungal infection of the foot
nn Low levels of white blood cells shown in your regular blood
tests
nn Mild allergic reaction
nn Feeling anxious
nn Feeling weak, numb, tingling or pain in the lower back or
leg (sciatica); feeling numb, burning, tingling or pain in the
hands and fingers, increased feeling of sensitivity, especially
in the skin; stabbing or throbbing pain along one or more
nerves.
6
Teriflunomide (Aubagio) 14mg once daily tablet
nn Increase in blood pressure, this is usually mild.
nn Vomiting
nn Toothache
nn Rash, acne
nn Pain of the tendons, joints, bones, muscle pain
nn Needing to urinate more often than usual
nn Heavy periods
nn Pain
nn Changes in liver and white cell test
nn Weight loss
Uncommon side effects (may effect up to 1 in 100):
nn Decrease in the number of red cells (anaemia)
and a decrease in the number of blood platelets
(thrombocytopenia)
nn Peripheral Neuropathy. In placebo controlled trials
peripheral nerve damage including carpal tunnel syndrome
was seen more commonly in patients taking Teriflunomide
than those taking placebo. The symptoms of peripheral
nerve damage can sometimes be difficult to determine
from MS symptoms.
Very rare side effects (may effect up to 1 in 10,000 people)
nn Inflammation of the lung (interstitial lung disease)
nn Inflammation of the pancreas (pancreatitis)
Teriflunomide (Aubagio) 14mg once daily tablet
7
Can this medication cause Cancer?
There does not appear to be an increased risk of malignancy
with Teriflunomide within the clinical trials. The risk of cancer,
particularly cancer of the white blood cells, is increased with
use of some other agents that affect the immune system (class
effect).
What happens next?
If you and your consultant decide this is the right treatment for
you, an appointment may be arranged for you to attend your
MS Outpatient Clinic for baseline assessments and bloods.
Providing all your assessments are within normal limits we will
proceed with requesting your prescription.
The medication will be delivered to your nominated delivery
address after a prescription is issued by your MS doctor. It is very
important that you read the product information provided with
the medication. It is also very important that you remember to
take this medication on a regular basis and do not accidently
take more than one dose within 24 hours.
It will be your or your carer’s responsibility to ensure that you
have the recommended blood tests after starting Teriflunomide.
These should ideally be carried out at your GP surgery. However
if this is not possible the MS team can try to help.
Alternative medications
Currently there are other therapies recommended for the
treatment of relapses however these will be offered to you if
appropriate by your Consultant.
8
Teriflunomide (Aubagio) 14mg once daily tablet
Frequently asked Questions
Can I go abroad?
Yes. You can continue your medication as normal. Check with
your airline first to ensure a ‘letter to travel with medication’ is
not needed.
What if I need vaccinations?
Always check with your GP, Consultant or MS Specialist nurse
before you have any vaccinations.
Live vaccinations may carry the risk of infection and
should therefore be avoided.
Can I drink alcohol?
There is no firm evidence to suggest that alcohol should be
avoided however please drink responsibly in accordance with
government guidelines.
What if I miss a dose?
If you forget a dose one day, do not take two doses at the
same time. Continue to take the next dose as you normally
would.
Do not stop Teriflunomide without talking to your consultant
first.
Can I still have Steroids whilst taking Teriflunomide?
Yes if necessary. Your Consultant or GP will advise on the use of
steroids if they are required.
Can I drive?
Teriflunomide may cause you to feel dizzy, which will possibly
impair your ability to concentrate and react. If you are affected
by this you should not drive or use any machinery.
Teriflunomide (Aubagio) 14mg once daily tablet
9
Do I need to inform other health care professionals that I
am taking this drug?
Yes. We will let your GP know, but other health care
professionals such as other GPs or your Dentist may want to
prescribe you new medication. Please always inform your
GP / dentist or other prescribing doctor that you are taking
Teriflunomide when new medications are suggested.
What shall I do if I wish to become pregnant?
If you are considering starting a family in the near future you
MUST discuss your plans with a health care professional prior to
stopping medication and contraception.
10
Teriflunomide (Aubagio) 14mg once daily tablet
More information
You can find further information and support from the following
organisations:
Multiple Sclerosis Trust
www.mstrust.org.uk
Multiple Sclerosis Society
www.mssociety.org.uk
NICE
www.nice.org.uk
References:
Summary of product characteristics, 2013, Sanofi-aventis groupe:
Paris
Information for the patient, 2013, Sanofi-aventis groupe: Paris
National Institute for Health and Excellence (Nice) Teriflunomide
for treating relapsing-remitting multiple sclerosis, 2014, Nice:
London
NHS Constitution. Information on your rights and responsibilities.
Available at www.nhs.uk/aboutnhs/constitution
Teriflunomide (Aubagio) 14mg once daily tablet
11
www.nbt.nhs.uk
If you or the individual you are caring for need support reading
this leaflet please ask a member of staff for advice.
© North Bristol NHS Trust. This edition published May 2014. Review due May 2016. NBT002842