Fingolimod hydrochloride
Consumer Medicine Information (CMI)
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about . It does not contain all the information that is known about . It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.
What Gilenya is used for
Gilenya is a new type of medicine known as sphingosine 1-phosphate (S1-P) receptor modulators. The active substance of Gilenya is fingolimod.
Gilenya can alter the way the body's immune system works and is used to treat relapsing remitting multiple sclerosis (MS) and relapses in patients with secondary progressive multiple sclerosis.
Gilenya slows down the progression of physical disability and decreases the number of flare-ups (relapses) in patients with some relapsing forms of MS.
Gilenya helps to fight against attacks of 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.
This medicine is only available with a doctor's prescription. It is not addictive.
There is not enough information to recommend this medicine for children.
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 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 structure).
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 that case, 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, 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 do become pregnant while taking Gilenya tell your doctor right away. 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. Talk with your doctor before breast-feeding while you take Gilenya.
Tell your doctor if you have any of the following medical conditions:
if you have a slow resting heart rate (less than 55 beats per minute), if you are taking medicines that slow your heart rate, if you have irregular or abnormal heartbeat or a history of sudden loss of consciousness.
if you have no history of chickenpox or have not been vaccinated against varicella zoster virus. Your doctor may decide to test your status and vaccinate you against this virus (if you do not have enough antibodies to this virus). In this case you will start Gilenya one month after the vaccination.
if you plan to get vaccinated. During and for up to 2 months after treatment with Gilenya, you should not get certain types of vaccines (live attenuated vaccines) and some others may not work well.
if you have a lowered immune response (due to a disease or medicines that suppress the immune system). You may get infections more easily or an infection you already have may get worse.
if you have or have had 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) or if you have diabetes. Your doctor may want you to undergo an eye examination before you start Gilenya and at regular intervals after the start of Gilenya treatment.
problems with your liver. Gilenya may increase the risk of abnormal results of liver function tests.
If you are not sure whether any of the above conditions apply to you, your doctor can advise you.
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.
You may need to take different amounts of your medicines or to take different medicines while you are taking Gilenya. Your doctor and pharmacist have more information.
Tell your doctor if you are taking any of the following medicines:
medicines for irregular heartbeat such as quinidine, procainamide, amiodarone or sotalol. Your doctor may decide not to use Gilenya if you take these medicines due to a possible added effect on irregular heartbeat;
medicines that slow down heartbeat (called beta-blockers) such as atenolol due to a possible added effect on heartbeat on the first days you start Gilenya;
medicines that suppress or modulate the immune system including other medicines used to treat MS such as beta-interferon, glatiramer acetate, natalizumab or mitoxantrone due to a possible added effect on the immune system;
vaccines. During and for up to 2 months after treatment with Gilenya, administration of some vaccines containing live virus may result in infection that the vaccination should prevent, while others may not work well.
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 for help.
How much to take
The usual dose is one capsule per day (0.5 mg of fingolimod). Do not exceed the recommended dose.
How to take it
Swallow Gilenya capsules with a glass of water.
Gilenya can be taken with or without food.
First dose precaution
Before you take the first dose of Gilenya, your doctor may do an ECG to check your heart rate and rhythm.
You will need to stay at the doctor's office or clinic for 6 hours after taking the first dose of Gilenya so that your heart rate can be checked. At the beginning of treatment, Gilenya causes the heart rate to slow down. Gilenya can also cause an irregular heartbeat, especially after the first dose. Irregular heartbeat usually returns to normal in less than one day. Slow heart rate usually returns to normal within one month.
Tell your doctor if you feel dizzy or tired or are conscious of your heartbeat.
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 food.
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.
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 have to restart Gilenya more than 2 weeks after you stopped taking it, the initial effect on your heart rate may occur again.
If you are a woman, see section Things you must do.
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.
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 some hints.
If you take too much (overdose)
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. 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.
Symptoms of an overdose may include:
swelling in hands or feet
tingling or numbness in hands or feet
muscle pain
fever
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 macula oedema (swelling of a small area at the back of the eye), which 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 if you think you have an infection, have fever, or feel like you have the flu.
Gilenya lowers the white blood cell count (particularly the lymphocyte count). White blood cells fight infection. 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.
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 the medicine.
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
Do not give this medicine to anyone else, even if their condition seems similar to yours.
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.
Side effects
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:
bronchitis with symptoms such as cough with phlegm, chest pain, fever
gastroenteritis with symptoms such as vomiting, nausea, diarrhoea, fever
herpes virus infection (shingles or herpes zoster) with symptoms such as blisters, burning, itching or pain around the mouth or genitals. Other symptoms may be fever and weakness in the early stages of infection, followed by numbness, itching, and red patches or blisters on the face or trunk, with severe pain
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).
The above side effects are common and can be serious.
pneumonia with symptoms such as fever, cough, difficulty breathing
symptoms such as shadows or blind spot in the center of the 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).
The above side effects are uncommon and can be serious. If you experience any of these, tell your doctor straight away.
infection from flu virus with symptoms such as tiredness, chills, sore throat, joint or muscles aching, fever
headache
diarrhoea
back pain
cough
The above side effects are very common and non-serious. If any of these affects you severely, tell your doctor.
feeling of pressure or pain in the cheeks and forehead (sinusitis)
infection from fungi affecting the skin, hair or nails (ringworm)
dizziness
tingling or numbness
severe headache often accompanied by nausea, vomiting and sensitivity to light (signs of migraine)
weakness
itchy, red, burning rash (signs of eczema)
hair loss
itching
weight loss
breathlessness
abnormal lung function test results starting after one month of treatment, remaining stable after that and reversible after treatment discontinuation
abnormal liver function test results
depression
eye pain
hypertension (Gilenya may cause a mild increase in blood pressure).
The above effects are common and non-serious. If any of these affects you severely, tell your doctor.
Tell your doctor immediately or go to Accident and Emergency if you notice any of the following:
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
sudden onset of rash or hives
yellow skin or eyes, light-coloured or darkening of the urine, unexplained nausea, vomiting, abdominal pain, tiredness or loss of appetite. Your doctor may request blood tests to check and to monitor your liver function and may consider stopping treatment if your liver problem is serious.
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
Storage
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.
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.
Disposal
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.
Product description
What it looks like
Gilenya 0.5 mg 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 boxes containing 7 or 28 capsules.
Ingredients
Each Gilenya capsule contains 0.56 mg of fingolimod hydrochloride (equivalent to 0.5 mg of fingolimod) as the active ingredient. It also contains the following inactive ingredients:
mannitol
magnesium stearate
titanium dioxide
gelatin
Gilenya does not contain gluten, tartrazine or any other azo dyes.
Sponsor
Gilenya is supplied in Australia by:
NOVARTIS Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
North Ryde NSW 2113
Telephone: 1 800 671 203
Web site: www.novartis.com.au
® = Registered Trademark
This leaflet was prepared in
April 2011.
Australian Registration Number:
0.5 mg capsule - AUST R 169890
