FINGOLIS

▼ 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.

FINGOLIS

Active ingredient(s): fingolimod

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Consumer Medicine Information (CMI)

This leaflet provides important information about using FINGOLIS. 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 FINGOLIS.

Where to find information in this leaflet:

1. Why am I using FINGOLIS?
2. What should I know before I use FINGOLIS?
3. What if I am taking other medicines?
4. How do I use FINGOLIS?
5. What should I know while using FINGOLIS?
6. Are there any side effects?
7. Product details

1. Why am I using FINGOLIS?

FINGOLIS contains the active ingredient fingolimod. FINGOLIS belongs to a group of medicines known as sphingosine 1‐phosphate (S1‐P) receptor modulators.

FINGOLIS is used to alter the way the body’s immune system works and is used is used to treat relapsing remitting multiple sclerosis (MS) and relapses in patients with secondary progressive 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.

Fingolimod 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.

Fingolimod 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 FINGOLIS 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 or adolescents under 18 years of age Experience with FINGOLIS in older people (more than 65 years old) is limited.

Talk to your doctor if you have any concerns.

2. What should I know before I use FINGOLIS?

Warnings

Do not use FINGOLIS if:

• you are allergic to fingolimod, or any of the ingredients listed at the end of this leaflet.
• Always check the ingredients to make sure you can use this medicine.
• any other similar medicines (such as medicines of the same class or with a similar structure)
• 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).

Check with your doctor if you have 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

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

Checking the health of your heart is important. If any of the following applies to you, your doctor may decide not to use FINGOLIS:

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

Tell your doctor if you have never had chickenpox or 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 FINGOLIS treatment one month after the full course of the vaccination is completed.

Tell your doctor before taking FINGOLIS 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. FINGOLIS 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 FINGOLIS (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 FINGOLIS, 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 FINGOLIS

• You will have a blood test to check your liver function before and during treatment with Fingolis 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.

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

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

You should avoid becoming pregnant while taking FINGOLIS or in the two months after you stop taking it because FINGOLIS may harm your unborn baby.

If you become pregnant while taking FINGOLIS, 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 FINGOLIS.

FINGOLIS can pass into breast milk and there is a risk of serious side effects for a breast‐fed baby.

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 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 FINGOLIS”)
• 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 FINGOLIS 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 FINGOLIS
• 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 FINGOLIS, 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 FINGOLIS. Your doctor and pharmacist can provide you with more information.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect FINGOLIS.

4. How do I use FINGOLIS?

How much to take

The usual dose is one capsule per day (0.5 mg of fingolimod).

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 FINGOLIS 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 FINGOLIS.

FINGOLIS 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.

When to take / use FINGOLIS

FINGOLIS should be used taken at 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 to take FINGOLIS

Swallow the capsule with a glass of water.

FINGOLIS can be taken with or without food

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.

First dose precaution

Because FINGOLIS may have a short‐term effect on your heart rate when you take the first dose, you will be required to have the health of your heart checked:

• before your first dose of FINGOLIS
• 6 hours after taking your first dose of FINGOLIS, and
• if you start FINGOLIS again after a break from therapy (depending on how long the break is and how long you have been receiving FINGOLIS treatment).

You will need to stay at the doctor’s office or clinic for 6 hours after taking the first dose of FINGOLIS 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 FINGOLIS will also apply for your second dose.

At the beginning of treatment, FINGOLIS 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.

FINGOLIS 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

If you stop taking FINGOLIS:

• for 1 day or more during your 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 FINGOLIS treatment, the initial effect on your heart rate may occur again.

If you restart FINGOLIS 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 use FINGOLIS

Fingolis 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.

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 use too much FINGOLIS

If you think that you have used too much FINGOLIS, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), 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.

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
• muscle pain
• fever

5. What should I know while using FINGOLIS?

Things you should do

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

FINGOLIS should not be taken if you are pregnant.

Call your doctor straight away if you:

• 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.

FINGOLIS 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 FINGOLIS and for up to 2 months after you stop taking it. Any infection that you already have may get worse. Infections can 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 FINGOLIS. 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 FINGOLIS.

Limit your exposure to the sun and UV rays by wearing appropriate clothing and regularly applying sunscreen.

This will help minimise your risk of developing skin cancers.

Tell your doctor straight away, if you notice any of following symptoms while you are taking FINGOLIS because it could be serious:

• signs that your MS is getting worse (e.g. weakness or visual change) or if you notice any new or unusual symptoms. 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 FINGOLIS.
• 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 seizures/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 syndrome (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 FINGOLIS.

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

Remind any doctor, dentist or pharmacist you visit that you are using FINGOLIS.

Things you should not do

• Do not stop using this medicine suddenly.

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.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how FINGOLIS affects you.

Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely. FINGOLIS is not expected to have an influence on your ability to drive and use machines.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

• 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 25°C.

Follow the instructions in 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.

A locked cupboard at least one‐and a‐half metres above the ground is a good place to store medicines.

When to discard your medicine (as relevant)

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.

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

Less serious side effects

What to do

More broad or affecting different parts of the body: 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 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 or joint pain

Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

More broad or affecting different parts of the body: 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 FINGOLIS (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 convulsion, 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 of 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. 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 or seizures (fits) which are symptoms of a cryptococcal infection (a type of fungal infection), including cryptococcal meningitis., or meningitis/encephalits (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 (FINGOLIS 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.

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these 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. 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 Fingolis contains

Active ingredient (main ingredient)	Fingolimod hydrochloride (equivalent to 0.5 mg of fingolimod)
Other ingredients (inactive ingredients)	pregelatinized maize starch fumaric acid stearic acid titanium dioxide black ink (TekPrint SW‐9008) gelatin

Do not take this medicine if you are allergic to any of these ingredients.

What FINGOLIS looks like

FINGOLIS hard capsules contain white to off white powder in hard gelatin capsules. The capsules comprise a white opaque body imprinted in black ink with ‘MF’ and white opaque cap imprinted in black ink with ‘0.5mg’ (AUST R 302761).

FINGOLIS are available in packs of 7, 28 and 84. Not all pack sizes may be marketed in Australia.

Who distributes FINGOLIS

Cipla Australia Pty Ltd
Level‐1, 132‐136 Albert Road,
South Melbourne, VIC 3205
drugsafety@Cipla.com
Phone: 1800‐569‐074

This leaflet was prepared in March 2021