Fynod

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NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

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.

Fingolimod hydrochloride

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about FYNOD.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the benefits he/she expects FYNOD will provide to you against the risks in deciding to prescribe this medicine for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What FYNOD is used for

FYNOD contains the active substance fingolimod, which belongs to a group of medicines known as sphingosine 1-phosphate (S1-P) receptor modulators. FYNOD 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.

FYNOD 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.

FYNOD 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 FYNOD 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.

FYNOD is used in children and adolescents (10 years of age and above) to treat relapsing-multiple sclerosis. FYNOD has not been studied in children under 10 years of age.

Experience with FYNOD in older people (more than 65 years old) is limited.

Talk to your doctor if you have any concerns.

Before you take FYNOD

When you must not take it

Do not take FYNOD 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 FYNOD if you have 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 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, preservatives or dyes.

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 FYNOD or in the two months after you stop taking it because FYNOD may harm your unborn baby.

If you become pregnant while taking FYNOD, 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 FYNOD.

FYNOD 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 FYNOD.

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 FYNOD or may refer you first to a cardiologist for further advice before commencing your first dose of FYNOD.

If your doctor thinks that FYNOD 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 FYNOD.

Tell your doctor if you have never had chickenpox or have no record of vaccination against chickenpox.

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 FYNOD 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 FYNOD.

Tell your doctor before taking FYNOD 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. FYNOD 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 FYNOD (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 FYNOD, your doctor will confirm whether you have enough white blood cells (these fight infections) in your blood.

If you are not sure whether any of the above conditions apply to you, your doctor can advise you.

Before you start treatment with FYNOD:

You will have a blood test to check your liver function before and during treatment with FYNOD and until two months after stopping treatment. If liver problems are detected your doctor may decide to discontinue treatment.

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)

diabetes.

vaccination against human papilloma virus (HPV) is recommended. If you are female, your doctor will also recommend HPV screening.

If you are female, a pregnancy test is recommended to check if you are pregnant.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your 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 FYNOD")

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 FYNOD 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 FYNOD.

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 FYNOD, 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 FYNOD. Your doctor and pharmacist can provide you with more information.

If you have not told your doctor about any of these things, tell him/ her before you start taking this medicine.

How to take FYNOD

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

First dose precaution

Because FYNOD 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 FYNOD

6 hours after taking your first dose of FYNOD, and

if you start FYNOD again after a break from therapy (depending on how long the break is and how long you have been receiving FYNOD treatment).

You will need to stay at the doctor's office or clinic for 6 hours after taking the first dose of FYNOD (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 ECG.

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 FYNOD will also apply for your second dose.

At the beginning of treatment, FYNOD 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.

FYNOD 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

Adults

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 period.

Do not exceed the recommended dose.

How to take it

Swallow the capsule with a glass of water.

FYNOD 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 food.

How long to take it

Continue taking your medicine for as long as your doctor tells you.

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 FYNOD 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 FYNOD.

FYNOD 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 FYNOD:

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 FYNOD treatment, the initial effect on your heart rate may occur again.

If you restart FYNOD 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 some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much FYNOD. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention. Your doctor may decide to observe your with hourly heart rate and blood pressure measurements, run ECGs, and he/she may decide to monitor your overnight.

Symptoms of an overdose may include:

swelling in hands or feet

tingling or numbness in hands or feet

muscle pain

fever

While you are using FYNOD

Things you must do

You should avoid becoming pregnant while taking FYNOD or in the two months after you stop taking it because FYNOD 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.

FYNOD 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.

FYNOD 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 FYNOD (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.

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 FYNOD. 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 FYNOD.

Limit your exposure to the sun and UV rays by wearing appropriate clothing and regularly applying sunscreen with a high degree of UV protection.

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 FYNOD 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) or a condition called tumefactive lesions. Your doctor may organise an MRI scan to decide if you need to stop taking FYNOD.

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, or seizure/fits (these may be symptoms of meningitis and/or encephalitis).

sudden onset of severe headache, confusion, seizures and vision changes which are symptoms of a condition called posterior reversible encephalopathy (PRES).

Swelling in your neck, armpits or groin, persistent tiredness, fever, night sweats, shortness of breath, unexplained weight loss, itchy skin which are symptoms of lymphoma

Unexplained nausea, vomiting, abdominal pain, tiredness, yellowing of the skin or whites of your eyes, abnormally dark urine. These may be signs of liver injury.

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. This includes blood tests to check your liver function and regular skin checks.

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

Tell any other doctor, dentist or pharmacist who treats you that you are taking FYNOD.

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 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. FYNOD 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 FYNOD 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:

flu symptoms such as tiredness, chills, sore throat, joint or muscles aching, fever

feeling of pressure or pain in the cheeks and forehead (sinusitis)

headache

diarrhoea

back pain

cough

weight loss

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 with ring-like red itchy rash

dizziness

severe headache often together with nausea, vomiting and sensitivity to light (signs of migraine)

weakness

itchy, red, burning rash (eczema)

itchy skin

breathlessness

blurred vision (see also information on macular oedema below)

nausea

muscle pain

joint pain

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 severe pain.

fever, cough, difficulty breathing, tiredness, aching joints and muscles which are signs of infections. While you are taking FYNOD (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 (thrombocytopenia).

yellowing if your skin or the whites of your eyes, abnormally dark urine, unexplained nausea, vomiting, pain on the right side of your stomach area, feeling less hungry than usual and tiredness, which may be signs of liver injury

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.

These side effects can be serious.

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

sudden onset of severe headache, confusion, seizures and/or vision changes, which are symptoms of a condition called posterior reversible encephalopathy (PRES).

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 meningitis or meningitis/encephalitis (caused by herpes or varicella zoster virus).

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 (FYNOD may cause a mild increase in blood pressure)

higher levels of liver enzymes and/or liver injury

increased level of blood fat (triglycerides)

changes to blood cell counts

abnormal lung function test results starting after one month of treatment, remaining stable after that and reversible after treatment discontinuation

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 FYNOD

Tell your doctor straight away, if you believe your MS is getting worse after you have stopped treatment with FYNOD, because it could be serious.

Symptoms of MS can return and may become worse compared to before or during treatment.

Storage

Keep your medicine in the pack until it is time to take them.

If you take medicine out of the pack they may not keep well.

Keep your medicine in a cool dry place where the temperature stays below 25°C.

Do not store FYNOD or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Keep it 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 medicine that is left over.

Product description

What it looks like

FYNOD 0.5 mg capsule: size 3, hard-shell capsule with brown-orange cap, white body, both printed axially with "MYLAN" over "FD 0.5" in black ink and filled with white to off-white powder.

FYNOD 0.5 mg capsules are available in packs containing 28 capsules.

FYNOD 0.25 mg capsules are not available.