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.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
Consumer Medicine Information (CMI)
What is in this leaflet
This leaflet answers some common questions about Gilenya.
It does not contain all the available information. It does not take the place of talking
to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on the final page.
More recent information on the medicine may be available.
You should ensure that you speak to your pharmacist or doctor to obtain the most up
to date information on the medicine. You can also download the most up to date leaflet
Any updates may contain important information about the medicine and its use of which
you should be aware.
All medicines have risks and benefits. Your doctor has weighed the benefits he/she
expects Gilenya will provide to you against the risks in deciding to prescribe this
medicine for you.
If you have any concerns about this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What Gilenya is used for
Gilenya contains the active substance fingolimod, which belongs to a group of medicines
known as sphingosine 1-phosphate (S1-P) receptor modulators. Gilenya can alter the
way the body's immune system works and is used in adults, children and adolescents
(10 years of age and above) to treat relapsing forms of multiple sclerosis (MS). MS
is a long-term condition that affects the central nervous system (CNS), particularly
how the brain and spinal cord work. In MS, inflammation destroys the protective cover
around the nerves (called myelin) and stops the nerves from working properly.
The cause of MS is unknown but it is thought that an abnormal response by the body's
immune system plays an important part in the process which damages the CNS.
This medicine slows down the progression of physical disability and decreases the
number of flare-ups (relapses) in patients with relapsing MS.
Gilenya helps to fight against attacks on myelin by the immune system by affecting
the ability of some white blood cells to move freely within the body and by stopping
the cells that cause inflammation from reaching the brain. This reduces nerve damage
caused by MS.
Gilenya may also have a direct and beneficial effect on certain brain cells (neural
cells) involved in repairing or slowing down the damage of MS.
Ask your doctor if you have any questions about how Gilenya works or why this medicine
has been prescribed for you or your child.
This medicine is only available with a doctor's prescription. It is not addictive.
Gilenya is used in children and adolescents (10 years of age and above) to treat relapsing-multiple
sclerosis. Gilenya has not been studied in children under 10 years of age.
Experience with Gilenya in older people (more than 65 years old) is limited.
Talk to your doctor if you have any concerns.
Before you take Gilenya
When you must not take it
Do not take Gilenya if you:
have had a heart attack, unstable angina, stroke or warning stroke or certain types
of heart failure in the last 6 months
have certain types of irregular or abnormal heartbeat (arrhythmia)
are taking or have recently taken medicine for irregular heartbeat such as quinidine,
disopyramide, amiodarone or sotalol (due to a possible added effect on irregular heartbeat).
Do not take Gilenya if you have an allergy to:
fingolimod (the active ingredient) or to any of the other ingredients listed at the
end of this leaflet
any other similar medicines (such as medicines of the same class or with a similar
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
In these cases, return it to your pharmacist.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, dyes or preservatives.
Your doctor will want to know if you are prone to allergies.
Tell your doctor if you are pregnant, think you might be pregnant soon, or are trying
to become pregnant.
You should avoid becoming pregnant while taking Gilenya or in the two months after
you stop taking it because Gilenya may harm your unborn baby.
If you become pregnant while taking Gilenya, tell your doctor without delay.
You and your doctor will decide what is best for you and your baby.
You should not breast-feed while you are taking Gilenya.
Gilenya can pass into breast milk and there is a risk of serious side effects for
a breast-fed baby.
Tell your doctor if you have had heart problems, a stroke or warning of a stroke.
Checking the health of your heart is important. If any of the following applies to
you, your doctor may decide not to use Gilenya:
irregular or abnormal heartbeat
severe heart disease
uncontrolled high blood pressure
history of stroke or other diseases related to blood vessels in the brain
severe breathing difficulties when asleep (sleep apnoea that is not treated)
a heart rhythm disturbances (called QTc prolongation or abnormal ECG heart tracing)
or the risk of these disturbances
slow heart rate or if you have a history of sudden loss of consciousness (fainting).
Your doctor may decide not to use Gilenya or may refer you first to a cardiologist
for further advice before commencing your first dose of Gilenya.
If your doctor thinks that Gilenya is appropriate for you, he/she may refer you first
to a cardiologist (doctor specialised in heart disease). You may also be monitored
overnight by a health care professional after taking the first dose of Gilenya.
Tell your doctor if you have never had chickenpox or have no record of vaccination
Your doctor will test your status of the antibody against this virus and may decide
to vaccinate you (if you do not have antibodies to this virus). In this case you will
start Gilenya treatment one month after the full course of the vaccination is completed.
Children or adolescents (10 years of age and above) need to have completed their vaccination
schedule before starting treatment with Gilenya.
Tell your doctor before taking Gilenya if you have one of the following medical conditions:
a lowered immune response (due to a disease or medicines that suppress the immune
system). See "taking other medicines". You may get infections more easily or an infection
you already have may get worse.
problems with your liver. You will have a blood test to check your liver function
before you start taking Gilenya. Gilenya may affect your liver function.
Tell your doctor if you plan to receive a vaccine.
You should not receive certain types of vaccines (called "live attenuated vaccines")
during and up to 2 months after treatment with Gilenya (see "Taking other medicines").
Tell your doctor if you have an infection as it may get worse.
Infections can be serious and sometimes life-threatening. Before you start taking
Gilenya, your doctor will confirm whether you have enough white blood cells (these
fight infections) in your blood.
Your doctor may also recommend vaccination against human papilloma virus (HPV) before
If you are not sure whether any of the above conditions apply to you, your doctor
can advise you.
Before you start treatment with Gilenya:
A skin examination is recommended before you start and at regular intervals during
treatment. Your doctor will decide what to do if skin problems are noticed.
an eye examination before you start treatment and at regular intervals afterwards
is recommended if you have or have had one of the following conditions:
visual disturbances or other signs of swelling in the central vision area at the back
of the eye (a condition known as macular oedema)
inflammation or infection of the eye (uveitis)
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any
that you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines may interfere with this medicine. Tell your doctor if you are taking
any of the following:
medicines for an irregular or abnormal heartbeat such as quinidine, procainamide,
amiodarone or sotalol (see section "Do not take Gilenya")
medicines that slow down heartbeat such as atenolol (a beta-blocker); verapamil, diltiazem
or (calcium channel blockers) or ivabradine or digoxin. Your doctor may decide not
to use Gilenya or may refer you first to a cardiologist to switch to medicines that
do not slow your heart rate or to decide how you should be observed after the first
dose of Gilenya
medicines that can cause an abnormal heart rhythm called Torsades de Pointes such
as citalopram, chlorpromazine, haloperidol, methadone or erythromycin
medicines that suppress or modulate the immune system including other medicines used
to treat MS such as beta-interferon, glatiramer acetate, natalizumab mitozantrone,
dimethyl fumarate, teriflunomide, alemtuzumab or corticosteroids due to a possible
added effect on the immune system
vaccines. If you need to receive a vaccine, seek your doctor's advice first. During
and up to 2 months after treatment with Gilenya, administration of some vaccines containing
live virus (live attenuated vaccines) may result in an infection that the vaccination
is designed to prevent, while others may not work as well.
You may need to take different amounts of your medicines or to take different medicines
while you are taking Gilenya. Your doctor and pharmacist can provide you with more
If you have not told your doctor about any of these things, tell him/her before you
start taking this medicine.
How to take Gilenya
Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the label, ask your doctor or pharmacist
First dose precaution
Because Gilenya may have a short-term effect on your heart rate when you take the
first dose (or when children/adolescents switch from the 0.25 mg capsule to the 0.5
mg capsule), you will be required to have the health of your heart checked:
before your first dose of Gilenya
6 hours after taking your first dose of Gilenya, and
if you start Gilenya again after a break from therapy (depending on how long the break
is and how long you have been receiving Gilenya treatment).
You will need to stay at the doctor's office or clinic for 6 hours after taking the
first dose of Gilenya (or after taking the first dose of 0.5 mg when your child switches
from the 0.25 mg capsule daily dose) so that your heart rate and blood pressure can
be checked each hour. Your doctor will also check and record the electrical activity
of your heart (using a test called an ECG), and check your heart rhythm.
Tell your doctor if you feel dizzy, tired, or are conscious of your heartbeat.
At the end of the 6-hour observation period, you will be required to have a second
In case of unusual ECG or slow heart rate at the end of the 6-hour observation period,
you may be observed for longer and overnight if necessary. In this case, the same
observation process that took place for your first dose of Gilenya will also apply
for your second dose.
At the beginning of treatment, Gilenya can cause the heart rate to slow down in some
patients. If your heart rate slows down after your first dose, you may feel dizzy
or tired or be consciously aware of your heartbeat. If your heart rate slows down
too much or your blood pressure drops, you may need treatment without delay. Slow
heart rate usually returns to normal within one month.
Gilenya can also cause an irregular heartbeat in some patients, especially after the
first dose. Irregular heartbeat usually returns to normal in less than one day.
How much to take
The usual dose is one capsule per day (0.5 mg of fingolimod).
Children and adolescents (10 years of age and above)
The dose depends on the body weight:
Children and adolescents who weigh 40 kg or less: one 0.25 mg capsule per day.
Children and adolescents with a body weight above 40 kg: one 0.5 mg capsule per day.
Children and adolescents who started on one 0.25 mg capsule per day and reach a stable
body weight above 40 kg will be instructed by their doctor to switch to one 0.5 mg
capsule per day. In this case, it is recommended to repeat the first dose observation
Do not exceed the recommended dose.
How to take it
Swallow the Gilenya capsule with a glass of water.
Gilenya can be taken with or without food.
When to take it
Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it. It does not matter if you take this medicine before or after
How long to take it
Continue taking your medicine for as long as your doctor tells you to.
Your doctor will check your progress to make sure the medicine is working and will
discuss with you how long your treatment should continue.
Do not stop taking Gilenya unless your doctor tells you to.
Your symptoms may return or become worse if you stop the treatment. Tell your doctor
if you have worsening of MS symptoms after stopping Gilenya.
Gilenya will stay in your body for up to 2 months after you stop taking it. Your white
blood cell count (lymphocyte count) may also remain low during this time and the side
effects described in this leaflet may still occur.
If you stop taking Gilenya:
for 1 day or more during the first 2 weeks of treatment, or
for more than 7 days during weeks 3 and 4 of treatment, or
for more than 2 weeks after your first month of Gilenya treatment,
the initial effect on your heart rate may occur again.
If you restart Gilenya therapy after a break, your doctor may decide to monitor your
heart rate and blood pressure every hour, to run ECGs, or to monitor you overnight.
If you forget to take it
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 that you missed.
If you miss a dose during the first 2 weeks call your doctor right away.
Your doctor may decide to observe you at the time you take the next dose.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for
If you take too much (overdose) or if you have taken a first dose by mistake
Immediately telephone your doctor or Poisons Information Centre (telephone number:
13 11 26), or go to Accident and Emergency at your nearest hospital if you think that
you or anyone else may have accidentally taken too much Gilenya or taken a first dose
of Gilenya by mistake. Do this even if there are no signs of discomfort or poisoning.
Keep the telephone numbers for these places handy.
You may need urgent medical attention. Your doctor may decide to observe you with
hourly heart rate and blood pressure measurements, run ECGs, and he/she may decide
to monitor you overnight.
Symptoms of an overdose may include:
swelling in hands or feet
tingling or numbness in hands or feet
While you are taking Gilenya
Things you must do
You should avoid becoming pregnant while taking Gilenya or in the two months after
you stop taking it because Gilenya may harm your unborn baby.
Talk to your doctor about the associated risk. Talk with your doctor about reliable
methods of birth control that you should use during treatment and for 2 months after
you stop treatment.
If you become pregnant while taking this medicine, tell your doctor immediately.
Gilenya should not be taken if you are pregnant.
Tell your doctor about any changes in your vision, especially if:
the centre of your vision gets blurry or has shadows
if you develop a blind spot in the centre of your vision
if you have problems seeing colours or fine detail.
Gilenya may cause macular oedema uncommonly (swelling of a small area at the back
of the eye). When this side effect does occur, it usually happens in the first 4 months
of treatment. Your chance of developing macular oedema is higher if you have diabetes
or have had an inflammation of the eye called uveitis. It can cause some of the same
vision symptoms as an MS attack (optic neuritis).
Tell your doctor straight away if you think you have an infection, have fever, or
feel like you have the flu.
You may get infections more easily while you are taking Gilenya (and for up to 2 months
after you stop taking it). Any infection that you already have may get worse. Infections
could be serious and sometimes life-threatening.
If you are a woman, your doctor may recommend screening for HPV.
Talk to your doctor straight away if you notice any skin nodules (e.g. shiny pearly
nodules), patches or open sores that do not heal within weeks.
Skin cancers have been reported in MS patients treated with Gilenya. Symptoms may
include abnormal growth or changes of skin tissue (e.g. unusual moles) which may change
in colour, shape or size over time.
Your doctor should carry out regular skin examinations during your treatment with
Limit your exposure to the sun and UV rays by wearing appropriate clothing and regularly
This will help minimise your risk of developing skin cancers.
Tell your doctor straight away, if you get any of the following symptoms or diseases
during your treatment with Gilenya because it could be serious:
If you believe your MS is getting worse (e.g. weakness or visual change) or if you
notice any new or unusual symptoms, talk to your doctor as soon as possible, because
these may be the symptoms of a rare brain disorder caused by infection and called
progressive multifocal leukoencephalopathy (PML).
If you think you have an infection; a fever; feel like you have the flu, or have a
headache accompanied by stiff neck, sensitivity to light, nausea, and/or confusion
(these may be symptoms of meningitis).
sudden onset of severe headache, confusion, seizures and vision changes which are
symptoms of a condition called posterior reversible encephalopathy (PRES).
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor will do regular checks to help prevent you from having side effects from
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking Gilenya.
Tell any other doctor, dentist or pharmacist who treats you that you are taking Gilenya.
Things you must not do
You should not receive certain types of vaccines (live attenuated vaccines) during
and for up to 2 months after treatment with this medicine (see "Taking other medicines").
Do not give this medicine to anyone else, even if their condition seems similar to
Do not use it to treat any other complaints unless your doctor tells you to.
Things to be careful of
Your doctor will tell you whether your illness allows you to drive vehicles and use
machines safely. Gilenya is not expected to have an influence on your ability to drive
and use machines.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking Gilenya even if you do not think it is connected with the medicine.
All medicines can have side effects. Sometimes they are serious, most of the time
they are not. You may need medical treatment if you get some of the side effects.
Do not be alarmed by these lists of possible side effects. You may not experience
any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following side effects and they worry you:
infection from flu virus with symptoms such as tiredness, chills, sore throat, joint
or muscles aching, fever
feeling of pressure or pain in the cheeks and forehead (sinusitis)
The above side effects are very common and non-serious. If any of these affects you
severely, tell your doctor.
Tell your doctor if you observe any of the following side effects (common and usually
not serious) and they affect you severely:
ringworm, a fungal infection affecting the skin (tinea versicolour)
severe headache often together with nausea, vomiting and sensitivity to light (signs
itchy, red, burning rash (eczema)
abnormal lung function test results starting after one month of treatment, remaining
stable after that and reversible after treatment discontinuation.
blurred vision (see also information on macular oedema below)
Tell your doctor straight away if you notice any of the following:
bronchitis with symptoms such as coughing with phlegm, chest pain, fever
shingles or herpes zoster symptoms such as blisters, burning, itching or pain of the
skin, typically on the upper body or face. Other symptoms may be fever and weakness
in the early stages of infection, followed by numbness, itching, and red patches with
fever, cough, difficulty breathing, tiredness, aching joints and muscles which are
signs of infections. While you are taking Gilenya (and for up to 2 months after you
stop taking it), you may get infections more easily. Any infection that you already
have may get worse. Infections could be serious and life-threatening.
slow heartbeat (bradycardia) or irregular heartbeat
pneumonia with symptoms such as fever, cough, difficulty breathing
shadows or blind spot in the centre of your vision, blurred vision, problems seeing
colours or details which are symptoms of macular oedema (swelling in the central vision
area of the retina at the back of the eye)
moles which may change size, shape, elevation or colour over time, or new moles which
may be symptoms of melanoma, a type of skin cancer usually developing from an unusual
mole (naevus). The moles may itch, bleed or ulcerate.
skin nodules (e.g. shiny pearly nodules), patches or open sores
skin lesions of unusual colour
convulsions, fits (more frequent in children and adolescents than in adults)
bleeding or bruising more easily than normal. This may be due to low level of platelets
These side effects can be serious.
Tell your doctor immediately or go to Accident and Emergency if you notice any of
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in
swallowing or breathing
sudden onset of rash or hives
yellowing of your skin or the whites of your eyes, abnormally dark urine, unexplained
nausea, vomiting and tiredness. Your doctor may carry out blood tests to check your
liver function and may consider stopping Gilenya treatment if your liver problem is
sudden onset of severe headache, confusion, seizures and/or vision changes, which
are symptoms of a condition called posterior reversible encephalopathy (PRES).
an infection, fever, feel like you have the flu, or have a headache accompanied by
stiff neck, sensitivity to light, nausea, and/or confusion which are symptoms of a
condition called cryptococcal infections (a type of fungal infection), including cryptococcal
worsening of MS symptoms (e.g. weakness or visual changes) which could be signs of
a rare brain disorder caused by infection called progressive multifocal leukoencephalopathy.
Some side effects may not give you any symptoms and can only be found when tests are
done. Some of these side effects include:
hypertension (Gilenya may cause a mild increase in blood pressure)
higher levels of liver enzymes
increased level of blood fat (triglycerides)
low level of white blood cells (lymphopenia, leucopenia).
Tell your doctor if you notice anything else that is making you feel unwell.
Some people may have other side effects not yet known or mentioned in this leaflet.
After using Gilenya
Tell your doctor straight away, if you believe your MS is getting worse after you
have stopped treatment with Gilenya, because it could be serious.
Symptoms of MS can return and may become worse compared to before or during treatment.
Keep your medicine in the original container until it is time to take it.
Store it in a cool dry place where the temperature stays below 30°C (0.5 mg capsule)
or 25°C (0.25 mg capsule).
Do not store Gilenya or any other medicine in the bathroom or near a sink.
Do not leave it in the car or on window sills.
Keep the medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
If your doctor tells you to stop taking this medicine or the expiry date has passed,
ask your pharmacist what to do with any capsules you have left over.
What it looks like
Gilenya 0.25 mg hard capsules have an ivory opaque body and cap, with black radial
imprint ''FTY 0.25mg'' on cap and black radial band on body, contains white to almost
Gilenya 0.5 mg hard capsules are white opaque body and bright yellow opaque cap; radial
imprint with black ink, "FTY 0.5 mg" on cap and two radial bands imprinted on the
body with yellow ink, containing white to almost white powder.
Gilenya capsules are available in packs containing 7 and 28 capsules.
Gilenya 0.25 mg
Each Gilenya capsule contains 0.28 mg of fingolimod hydrochloride (equivalent to 0.25
mg of fingolimod) as the active ingredient.
The capsule also contains the following inactive ingredients:
iron oxide yellow.
Gilenya 0.5 mg
Each Gilenya capsule contains 0.56 mg of fingolimod hydrochloride (equivalent to 0.5
mg of fingolimod) as the active ingredient.
The capsule also contains the following inactive ingredients:
magnesium stearate (E572)
titanium dioxide (E171)
Gilenya does not contain gluten, tartrazine or any other azo dyes.
Gilenya is supplied in Australia by:
NOVARTIS Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
Macquarie Park NSW 2113
Telephone: 1 800 671 203
Web site: www.novartis.com.au
®= Registered Trademark
This leaflet was prepared in April 2019.
Australian Registration Number:
0.25 mg capsule - AUST R 300029
0.5 mg capsule - AUST R 169890
(gil090419c.doc based on PI gil090419i.doc)