Fynod (Fingolimod hydrochloride) Drug / Medication Info

Fingolimod hydrochloride

Client Medication Info

What’s on this leaflet

This leaflet solutions some frequent questions on FYNOD.

It doesn’t comprise all of the out there info. It doesn’t take the place of speaking
to your physician or pharmacist.

All medicines have dangers and advantages. Your physician has weighed the advantages he/she
expects FYNOD will present to you towards the dangers in deciding to prescribe this
medication for you.

If in case you have any issues about taking this medication, ask your physician or pharmacist.

Hold this leaflet with the medication.

It’s possible you’ll have to learn it once more.

What FYNOD is used for

FYNOD incorporates the lively substance fingolimod, which belongs to a gaggle of medicines
often known as sphingosine 1-phosphate (S1-P) receptor modulators. FYNOD can alter the way in which
the physique’s immune system works and is utilized in adults, kids and adolescents (10
years of age and above) to deal with relapsing types of a number of sclerosis (MS). MS is
a long-term situation that impacts the central nervous system (CNS), notably
how the mind and spinal twine work. In MS, irritation destroys the protecting cowl
across the nerves (referred to as myelin) and stops the nerves from working correctly.

The reason for MS is unknown however it’s thought that an irregular response by the physique’s
immune system performs an necessary half within the course of which damages the CNS.

This medication slows down the development of bodily incapacity and reduces the
variety of flare-ups (relapses) in sufferers with relapsing MS.

FYNOD helps to combat towards assaults on myelin by the immune system by affecting the
skill of some white blood cells to maneuver freely throughout the physique and by stopping the
cells that trigger irritation from reaching the mind. This reduces nerve harm
attributable to MS.

FYNOD can also have a direct and useful impact on sure mind cells (neural
cells) concerned in repairing or slowing down the harm of MS.

Ask your physician in case you have any questions on how FYNOD works or why this medication
has been prescribed for you or your baby.

This medication is just out there with a physician’s prescription. It’s not addictive.

FYNOD is utilized in kids and adolescents (10 years of age and above) to deal with relapsing-multiple
sclerosis. FYNOD has not been studied in kids underneath 10 years of age.

Expertise with FYNOD in older individuals (greater than 65 years previous) is restricted.

Speak to your physician in case you have any issues.

When you need to not take it

Don’t take FYNOD should you:

have had a coronary heart assault, unstable angina, stroke or warning stroke or sure sorts
of coronary heart failure within the final 6 months

have sure sorts of irregular or irregular heartbeat (arrhythmia)

are taking or have lately taken medication for irregular heartbeat reminiscent of quinidine,
disopyramide, amiodarone or sotalol (resulting from a potential added impact on irregular heartbeat).

Don’t take FYNOD in case you have allergy to:

fingolimod (the lively ingredient) or to any of the opposite substances listed on the
finish of this leaflet

every other related medicines (reminiscent of medicines of the identical class or with an identical
construction)

A number of the signs of an allergic response could embody:

shortness of breath

wheezing or problem respiratory

swelling of the face, lips, tongue or different elements of the physique

rash, itching or hives on the pores and skin

Don’t take this medication after the expiry date printed on the pack or if the packaging
is torn or exhibits indicators of tampering.

In these circumstances, return it to your pharmacist.

Earlier than you begin to take it

Inform your physician in case you have allergic reactions to every other medicines, meals, preservatives
or dyes.

Your physician will wish to know if you’re susceptible to allergic reactions.

Inform your physician if you’re pregnant, suppose you may be pregnant quickly, or are attempting
to change into pregnant.

It’s best to keep away from turning into pregnant whereas taking FYNOD or within the two months after you
cease taking it as a result of FYNOD could hurt your unborn child.

In case you change into pregnant whereas taking FYNOD, inform your physician directly.

You and your physician will resolve what’s greatest for you and your child.

You shouldn’t breast-feed when you are taking FYNOD.

FYNOD can move into breast milk and there’s a threat of great unwanted side effects for a
breast-fed child.

Inform your physician in case you have had coronary heart issues, a stroke or warning of a stroke.

Checking the well being of your coronary heart is necessary. If any of the next applies to
you, your physician could resolve to not use FYNOD.

irregular or irregular heartbeat

extreme coronary heart illness

uncontrolled hypertension

historical past of stroke or different illnesses associated to blood vessels within the mind

extreme respiratory difficulties when asleep (sleep apnoea that isn’t handled)

a coronary heart rhythm disturbances (referred to as QTc prolongation or irregular ECG coronary heart tracing)
or the chance of those disturbances

gradual coronary heart fee or in case you have a historical past of sudden lack of consciousness (fainting).
Your physician could resolve to not use FYNOD or could refer you first to a heart specialist for
additional recommendation earlier than commencing your first dose of FYNOD.

In case your physician thinks that FYNOD is acceptable for you, he/she could refer you first
to a heart specialist (physician specialised in coronary heart illness). You might also be monitored
in a single day by a well being care skilled after taking the primary dose of FYNOD.

Inform your physician in case you have by no means had chickenpox or don’t have any report of vaccination
towards chickenpox.

Your physician will check your standing of the antibody towards this virus and should resolve
to vaccinate you (should you do not need antibodies to this virus). On this case you’ll
begin FYNOD remedy one month after the complete course of the vaccination is accomplished.

Kids or adolescents (10 years of age and above) have to have accomplished their vaccination
schedule earlier than beginning remedy with FYNOD.

Inform your physician earlier than taking FYNOD in case you have one of many following medical situations:

a lowered immune response (resulting from a illness or medicines that suppress the immune
system). See “taking different medicines”. It’s possible you’ll get infections extra simply or an an infection
you have already got could worsen.

Issues together with your liver. FYNOD could have an effect on your liver operate.

Inform your physician should you plan to obtain a vaccine.

You shouldn’t obtain sure sorts of vaccines (referred to as “stay attenuated vaccines”)
throughout and as much as 2 months after remedy with FYNOD (see “Taking different medicines”).

Inform your physician in case you have an an infection as it might worsen.

Infections might be severe and generally life-threatening. Earlier than you begin taking
FYNOD, your physician will affirm whether or not you will have sufficient white blood cells (these combat
infections) in your blood.

In case you are undecided whether or not any of the above situations apply to you, your physician
can advise you.

Earlier than you begin remedy with FYNOD:

You should have a blood check to verify your liver operate earlier than and through remedy
with FYNOD and till two months after stopping remedy. If liver issues are detected
your physician could resolve to discontinue remedy.

A pores and skin examination is really useful earlier than you begin and at common intervals throughout
remedy. Your physician will resolve what to do if pores and skin issues are seen.

a watch examination earlier than you begin remedy and at common intervals afterwards
is really useful in case you have or have had one of many following situations:

visible disturbances or different indicators of swelling within the central imaginative and prescient space on the again
of the attention (a situation often known as macular oedema)

irritation or an infection of the attention (uveitis)

diabetes.

vaccination towards human papilloma virus (HPV) is really useful. In case you are feminine,
your physician will even suggest HPV screening.

In case you are feminine, a being pregnant check is really useful to verify if you’re pregnant.

Taking different medicines

Inform your physician or pharmacist if you’re taking every other medicines, together with any
that you just get with out a prescription out of your pharmacy, grocery store or well being meals
store.

Some medicines could intrude with this medication. Inform your physician if you’re taking
any of the next:

medicines for an irregular or irregular heartbeat reminiscent of quinidine, procainamide,
amiodarone or sotalol (see part “Don’t take FYNOD”)

medicines that decelerate heartbeat reminiscent of atenolol (a beta blocker); verapamil, diltiazem
or (calcium channel blockers) or ivabradine or digoxin. Your physician could resolve not
to make use of FYNOD or could refer you first to a heart specialist to change to medicines that
don’t gradual your coronary heart fee or to resolve how you ought to be noticed after the primary
dose of FYNOD.

medicines that may trigger an irregular coronary heart rhythm referred to as Torsades de Pointes such
as citalopram, chlorpromazine, haloperidol, methadone or erythromycin

medicines that suppress or modulate the immune system together with different medicines used
to deal with MS reminiscent of beta-interferon, glatiramer acetate, natalizumab mitozantrone,
dimethyl fumarate, teriflunomide, alemtuzumab or corticosteroids resulting from a potential
added impact on the immune system

vaccines. If it’s worthwhile to obtain a vaccine, search your physician’s recommendation first. Throughout
and as much as 2 months after remedy with FYNOD, administration of some vaccines containing
stay virus (stay attenuated vaccines) could end in an an infection that the vaccination
is designed to forestall, whereas others could not work as nicely.

It’s possible you’ll have to take completely different quantities of your medicines or to take completely different medicines
when you are taking FYNOD. Your physician and pharmacist can give you extra info.

If in case you have not informed your physician about any of these items, inform him/ her earlier than you
begin taking this medication.

The way to take FYNOD

Observe all instructions given to you by your physician or pharmacist fastidiously.

They might differ from the data contained on this leaflet.

If you don’t perceive the directions on the field, ask your physician or pharmacist
for assist.

First dose precaution

As a result of FYNOD could have a short-term impact in your coronary heart fee while you take the primary
dose (or when kids/adolescents change from the 0.25 mg capsule to the 0.5 mg capsule),
you may be required to have the well being of your coronary heart checked:

earlier than your first dose of FYNOD

6 hours after taking your first dose of FYNOD, and

should you begin FYNOD once more after a break from remedy (relying on how lengthy the break
is and the way lengthy you will have been receiving FYNOD remedy).

You will want to remain on the physician’s workplace or clinic for six hours after taking the
first dose of FYNOD (or after taking the primary dose of 0.5 mg when your baby switches
from the 0.25 mg capsule every day dose) in order that your coronary heart fee and blood stress can
be checked every hour. Your physician will even verify and report {the electrical} exercise
of your coronary heart (utilizing a check referred to as an ECG), and verify your coronary heart rhythm.

Inform your physician should you really feel dizzy, drained, or are acutely aware of your heartbeat.

On the finish of the 6-hour commentary interval, you may be required to have a second
ECG.

In case of surprising ECG or gradual coronary heart fee on the finish of the 6-hour commentary interval,
it’s possible you’ll be noticed for longer and in a single day if needed. On this case, the identical
commentary course of that befell to your first dose of FYNOD will even apply for
your second dose.

Originally of remedy, FYNOD may cause the guts fee to decelerate in some
sufferers. In case your coronary heart fee slows down after your first dose, it’s possible you’ll really feel dizzy
or drained or be consciously conscious of your heartbeat. In case your coronary heart fee slows down
an excessive amount of or your blood stress drops, it’s possible you’ll want remedy directly. Gradual
coronary heart fee normally returns to regular inside one month.

FYNOD also can trigger an irregular heartbeat in some sufferers, particularly after the
first dose. Irregular heartbeat normally returns to regular in lower than in the future.

How a lot to take

Adults

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

Kids and adolescents (10 years of age and above)

The dose is dependent upon the physique weight:

Kids and adolescents who weigh 40 kg or much less: one 0.25 mg capsule per day.

Kids and adolescents with a physique weight above 40 kg: one 0.5 mg capsule per day.

Kids and adolescents who began on one 0.25 mg capsule per day and attain a steady
physique weight above 40 kg might be instructed by their physician to change to 1 0.5 mg
capsule per day. On this case, it is strongly recommended to repeat the primary dose commentary
interval.

Don’t exceed the really useful dose.

The way to take it

Swallow the capsule with a glass of water.

FYNOD might be taken with or with out meals.

When to take it

Take your medication at about the identical time every day.

Taking it on the similar time every day could have the most effective impact. It should additionally assist
you keep in mind when to take it. It doesn’t matter should you take this medication earlier than
or after meals.

How lengthy to take it

Proceed taking your medication for so long as your physician tells you.

Your physician will verify your progress to verify the medication is working and can
focus on with you the way lengthy your remedy ought to proceed.

Don’t cease taking FYNOD until your physician tells you to.

Your signs could return or change into worse should you cease the remedy. Inform your physician
in case you have worsening of MS signs after stopping FYNOD.

FYNOD will keep in your physique for as much as 2 months after you cease taking it. Your white
blood cell rely (lymphocyte rely) can also stay low throughout this time and the facet
results described on this leaflet should still happen.

In case you cease taking FYNOD:

for 1 day or extra through the first 2 weeks of remedy, or

for greater than 7 days throughout weeks 3 and 4 of remedy, or

for greater than 2 weeks after your first month of FYNOD remedy, the preliminary impact
in your coronary heart fee could happen once more.

In case you restart FYNOD remedy after a break, your physician could resolve to observe your
coronary heart fee and blood stress each hour, to run ECGs, or to observe you in a single day.

In case you neglect to take it

Whether it is virtually time to your subsequent dose, skip the dose you missed and take your subsequent
dose when you find yourself meant to.

Don’t take a double dose to make up for the dose that you just missed.

In case you miss a dose through the first 2 weeks name your physician straight away.

Your physician could resolve to look at you on the time you are taking the subsequent dose.

This will likely enhance the possibility of you getting an undesirable facet impact.

In case you are undecided what to do, ask your physician or pharmacist.

If in case you have bother remembering when to take your medication, ask your pharmacist for
some hints.

In case you take an excessive amount of (overdose)

Instantly phone your physician or the Poisons Info Centre (phone 13
11 26) for recommendation, or go to Accident and Emergency on the nearest hospital, should you
suppose that you just or anybody else could have taken an excessive amount of FYNOD. Do that even when there
aren’t any indicators of discomfort or poisoning.

It’s possible you’ll want pressing medical consideration. Your physician could resolve to look at your with
hourly coronary heart fee and blood stress measurements, run ECGs, and he/she could resolve
to observe your in a single day.

Signs of an overdose could embody:

swelling in fingers or toes

tingling or numbness in fingers or toes

muscle ache

fever

Issues you need to do

It’s best to keep away from turning into pregnant whereas taking FYNOD or within the two months after you
cease taking it as a result of FYNOD could hurt your unborn child.

Speak to your physician in regards to the related threat. Speak together with your physician about dependable
strategies of contraception that you must use throughout remedy and for two months after
you cease remedy.

In case you change into pregnant whereas taking this medication, inform your physician instantly.

FYNOD shouldn’t be taken if you’re pregnant.

Inform your physician about any adjustments in your imaginative and prescient, particularly if:

the centre of your imaginative and prescient will get blurry or has shadows

should you develop a blind spot within the centre of your imaginative and prescient

in case you have issues seeing colors or fantastic element.

FYNOD could trigger macular oedema uncommonly (swelling of a small space behind
the attention). When this facet impact does happen, it normally occurs within the first 4 months
of remedy. Your likelihood of growing macular oedema is greater in case you have diabetes
or have had an irritation of the attention referred to as uveitis. It will probably trigger a few of the similar
imaginative and prescient signs as an MS assault (optic neuritis).

Inform your physician right away should you suppose you will have an an infection, have fever, or
really feel like you will have the flu.

It’s possible you’ll get infections extra simply when you are taking FYNOD (and for as much as 2 months
after you cease taking it). Any an infection that you have already got could worsen. Infections
might be severe and generally life-threatening.

Speak to your physician right away should you discover any pores and skin nodules (e.g. shiny pearly
nodules), patches or open sores that don’t heal inside weeks.

Pores and skin cancers have been reported in MS sufferers handled with FYNOD. Signs could embody
irregular progress or adjustments of pores and skin tissue (e.g. uncommon moles) which can change in
color, form or measurement over time.

Your physician ought to perform common pores and skin examinations throughout your remedy with
FYNOD.

Restrict your publicity to the solar and UV rays by sporting acceptable clothes and commonly
making use of sunscreen with a excessive diploma of UV safety.

This may assist minimise your threat of growing pores and skin cancers.

Inform your physician right away, should you get any of the next signs or illnesses
throughout your remedy with FYNOD as a result of it might be severe:

In case you imagine your MS is getting worse (e.g. weak spot or visible change) or should you
discover any new or uncommon signs, speak to your physician as quickly as potential, as a result of
these stands out as the signs of a uncommon mind dysfunction attributable to an infection and referred to as
progressive multifocal leukoencephalopathy (PML) or a situation referred to as tumefactive
lesions. Your physician could organise an MRI scan to resolve if it’s worthwhile to cease taking
FYNOD.

In case you suppose you will have an an infection; a fever; really feel like you will have the flu, or have a
headache accompanied by stiff neck, sensitivity to gentle, nausea, and/or confusion,
or seizure/suits (these could also be signs of meningitis and/or encephalitis).

sudden onset of extreme headache, confusion, seizures and imaginative and prescient adjustments that are
signs of a situation referred to as posterior reversible encephalopathy (PRES).

Swelling in your neck, armpits or groin, persistent tiredness, fever, night time sweats,
shortness of breath, unexplained weight reduction, itchy pores and skin that are signs of lymphoma

Unexplained nausea, vomiting, stomach ache, tiredness, yellowing of the pores and skin or
whites of your eyes, abnormally darkish urine. These could also be indicators of liver damage.

Hold your whole physician’s appointments in order that your progress might be checked.

Your physician will do common checks to assist stop you from having unwanted side effects from
the medication. This consists of blood assessments to verify your liver operate and common pores and skin
checks.

In case you are about to be began on any new medication, remind your physician and pharmacist
that you’re taking FYNOD.

Inform every other physician, dentist or pharmacist who treats you that you’re taking FYNOD.

Issues you need to not do

You shouldn’t obtain sure sorts of vaccines (stay attenuated vaccines) throughout
and for as much as 2 months after remedy with this medication (see “Taking different medicines”).

Don’t give this medication to anybody else, even when their situation appears much like
yours.

Don’t use it to deal with every other complaints until your physician tells you to.

Issues to watch out of

Your physician will let you know whether or not your sickness permits you to drive autos and use
machines safely. FYNOD just isn’t anticipated to have an affect in your skill to drive
and use machines.

Negative effects

Inform your physician or pharmacist as quickly as potential if you don’t really feel nicely when you
are taking FYNOD even when you don’t suppose it’s linked with the medication.

All medicines can have unwanted side effects. Generally they’re severe, more often than not
they aren’t. It’s possible you’ll want medical remedy should you get a few of the unwanted side effects.

Don’t be alarmed by these lists of potential unwanted side effects. It’s possible you’ll not expertise
any of them.

Ask your physician or pharmacist to reply any questions you will have.

Inform your physician should you discover any of the next unwanted side effects they usually fear you:

flu signs reminiscent of tiredness, chills, sore throat, joint or muscle groups aching, fever

feeling of stress or ache within the cheeks and brow (sinusitis)

headache

diarrhoea

again ache

cough

weight reduction

The above unwanted side effects are quite common and non-serious. If any of those impacts you
severely, inform your physician.

Inform your physician should you observe any of the next unwanted side effects (frequent and normally
not severe) they usually have an effect on you severely:

ringworm, a fungal an infection affecting the pores and skin with ring-like pink itchy rash

dizziness

extreme headache typically along with nausea, vomiting and sensitivity to gentle (indicators
of migraine)

weak spot

itchy, pink, burning rash (eczema)

itchy pores and skin

breathlessness

blurred imaginative and prescient (see additionally info on macular oedema under)

nausea

muscle ache

joint ache

Inform your physician right away should you discover any of the next:

bronchitis with signs reminiscent of coughing with phlegm, chest ache, fever

shingles or herpes zoster signs reminiscent of blisters, burning, itching or ache of the
pores and skin, usually on the higher physique or face. Different signs could also be fever and weak spot
within the early phases of an infection, adopted by numbness, itching, and pink patches with
extreme ache.

fever, cough, problem respiratory, tiredness, aching joints and muscle groups that are
indicators of infections. If you are taking FYNOD (and for as much as 2 months after you
cease taking it), it’s possible you’ll get infections extra simply. Any an infection that you just already
have could worsen. Infections might be severe and life-threatening.

gradual heartbeat (bradycardia) or irregular heartbeat

pneumonia with signs reminiscent of fever, cough, problem respiratory

shadows or blind spot within the centre of your imaginative and prescient, blurred imaginative and prescient, issues seeing
colors or particulars that are signs of macular oedema (swelling within the central imaginative and prescient
space of the retina behind the attention)

moles which can change measurement, form, elevation or color over time, or new moles which
could also be signs of melanoma, a kind of pores and skin most cancers normally growing from an uncommon
mole (naevus). The moles could itch, bleed or ulcerate.

pores and skin nodules (e.g. shiny pearly nodules), patches or open sores

pores and skin lesions of surprising color

convulsions, suits (extra frequent in kids and adolescents than in adults)

bleeding or bruising extra simply than regular. This can be resulting from low stage of platelets
(thrombocytopenia).

yellowing in case your pores and skin or the whites of your eyes, abnormally darkish urine, unexplained
nausea, vomiting, ache on the correct facet of your abdomen space, feeling much less hungry
than normal and tiredness, which can be indicators of liver damage

worsening of MS signs (e.g. weak spot or visible adjustments) which might be indicators of
a uncommon mind dysfunction attributable to an infection referred to as progressive multifocal leukoencephalopathy.

These unwanted side effects might be severe.

Inform your physician instantly or go to Accident and Emergency should you discover any of
the next:

swelling of the face, lips, mouth, tongue or throat which can trigger problem in
swallowing or respiratory

sudden onset of rash or hives

sudden onset of extreme headache, confusion, seizures and/or imaginative and prescient adjustments, which
are signs of a situation referred to as posterior reversible encephalopathy (PRES).

headache accompanied by stiff neck, sensitivity to gentle, nausea, and/or confusion
that are signs of a situation referred to as cryptococcal infections (a kind of fungal
an infection), together with cryptococcal meningitis or meningitis/encephalitis (attributable to
herpes or varicella zoster virus).

Some unwanted side effects could not provide you with any signs and may solely be discovered when assessments are
finished. A few of these unwanted side effects embody:

hypertension (FYNOD could trigger a gentle enhance in blood stress)

greater ranges of liver enzymes and/or liver damage

elevated stage of blood fats (triglycerides)

adjustments to blood cell counts

irregular lung operate check outcomes beginning after one month of remedy, remaining
steady after that and reversible after remedy discontinuation

Inform your physician should you discover anything that’s making you’re feeling unwell.

Some individuals could produce other unwanted side effects not but identified or talked about on this leaflet.

After utilizing FYNOD

Inform your physician right away, should you imagine your MS is getting worse after you
have stopped remedy with FYNOD, as a result of it might be severe.

Signs of MS can return and should change into worse in comparison with earlier than or throughout remedy.

Storage

Hold your medication within the pack till it’s time to take them.

In case you take medication out of the pack they might not hold nicely.

Hold your medication in a cool dry place the place the temperature stays under 25°C.

Don’t retailer FYNOD or every other medication within the toilet or close to a sink. Don’t depart
it on a window sill or within the automotive.

Warmth and dampness can destroy some medicines.

Hold it the place kids can not attain it.

A locked cabinet a minimum of one-and-a-half metres above the bottom is an effective place
to retailer medicines.

Disposal

In case your physician tells you to cease taking this medication or the expiry date has handed,
ask your pharmacist what to do with any medication that’s left over.

What it appears like

FYNOD 0.5 mg capsule: measurement 3, hard-shell capsule with brown-orange cap, white physique,
each printed axially with “MYLAN” over “FD 0.5” in black ink and crammed with white
to off-white powder.

FYNOD 0.5 mg capsules can be found in packs containing 28 capsules.

FYNOD 0.25 mg capsules should not out there.

Components

FYNOD incorporates 500 microgram fingolimod (equal to 560 microgram fingolimod hydrochloride)
because the lively ingredient.

The capsule additionally incorporates the next inactive substances:

calcium hydrogen phosphate dihydrate

colloidal anhydrous silica

magnesium stearate

gelatin

titanium dioxide

pink iron oxide

yellow iron oxide

black iron oxide

potassium hydroxide

FYNOD additionally incorporates traces of sulfites.

Provider

FYNOD is equipped in Australia by:

Alphapharm Pty Ltd buying and selling as Viatris

Degree 1, 30 The Bond

30-34 Hickson Street

Miller Level NSW 2000

www.viatris.com.au

Cellphone: 1800 274 276

This leaflet was ready in September 2022.

0.5 mg capsule: AUST R 325742

Fynod_cmiSep22/00