FYNOD fingolimod (as hydrochloride) 500 microgram capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fingolimod hydrochloride, Quantity: 560 microgram (Equivalent: fingolimod, Qty 500 microgram)

Available from:

Alphapharm Pty Ltd

Pharmaceutical form:

Capsule

Composition:

Excipient Ingredients: calcium hydrogen phosphate dihydrate; glycine; colloidal anhydrous silica; magnesium stearate; titanium dioxide; iron oxide yellow; iron oxide red; potable water; Gelatin; propylene glycol; ethanol; butan-1-ol; purified water; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Administration route:

Oral

Units in package:

28 capsules, 84 capsules, 7 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

FYNOD is indicated for the treatment of adult and paediatric patients of 10 years of age and above with relapsing forms of multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

Product summary:

Visual Identification: 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; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2022-07-19

Patient Information leaflet

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.
FYNOD
®
_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

Summary of Product characteristics


This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any suspected
adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION
FYNOD
®
_Fingolimod capsules _
1
NAME OF THE MEDICINE
Fingolimod
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 500 microgram fingolimod (equivalent to 560
microgram fingolimod hydrochloride)
as the active ingredient.
Excipients with known effect: traces of sulfites.
For the full list of excipients, see Section
6.1 LIST OF
EXCIPIENTS
.
3
PHARMACEUTICAL FORM
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.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FYNOD is indicated for the treatment of adult and paediatric patients
of 10 years of age and above with
relapsing forms of multiple sclerosis to reduce the frequency of
relapses and to delay the progression of
disability.
4.2
DOSE AND METHOD OF ADMINISTRATION
FYNOD is unavailable in capsule strengths below 500 micrograms and is
therefore only appropriate for use
in paediatric patients weighing ≥ 40 kg. For paediatric patients
requiring treatment with lower strengths of
fingolimod, other brands are available.
In adults the recommended dose of FYNOD is one 0.5 mg capsule taken
orally once daily.
In paediatric patients (10 years of age and above), the recommended
dose is dependent on body weight:
•
Paediatric patients with body weight ≤ 40 kg: one 0.25 mg capsule
daily taken orally.
•
Paediatric patients with body weight > 40 kg: one 0.5 mg capsule daily
taken orally.
Paediatric patients who start on 0.25 mg capsules and subsequently
reach a stable body weight above 40 kg
should be switched to 0.5 mg capsules.
FYNOD can be taken with or without food. If a dose is missed,
treatment should be continued with the next
d