ILUVIEN fluocinolone acetonide 190 mcg intravitreal implant in applicator

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fluocinolone acetonide, Quantity: 190 microgram

Available from:

Specialised Therapeutics Alim Pty Ltd

Pharmaceutical form:

Implant

Composition:

Excipient Ingredients: polyvinyl alcohol; PMDA/ODA copolymer; dimeticonol; ethyltriacetoxysilane; methyltriacetoxysilane; dibutyltin diacetate; silica dimethicone silylate

Administration route:

Intravitreal-Within The Vitreous Cavity Of The Eye

Units in package:

1 implant in applicator

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ILUVIEN is indicated for the treatment of diabetic macular oedema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP).

Product summary:

Visual Identification: Drug core is a light brown filled tube, no visible deformation; Container Type: Carton; Container Material: Other composite material; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-08-06

Patient Information leaflet

20190729_ILU_CMI_AU_Cat 1-Approved
Page _ _1 of 3
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
https://www.tga.gov.au/reporting-problems.
ILUVIEN
â
_EE–LOO-VEE-UN_
_Fluocinolone Acetonide 190 mcg Intravitreal Implant in Applicator _
CONSUMER MEDICINE INFORMATION
JULY 2019
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Iluvien.
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 risks of your taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT ILUVIEN IS USED
FOR
Iluvien is a tiny tube that is inserted
into the eye and releases very small
amounts of the active ingredient,
fluocinolone acetonide, for up to 3
years. Fluocinolone acetonide
belongs to a group of medicines
called corticosteroids.
Iluvien is used to treat vision loss
associated with diabetic macular
oedema when other available
treatments have failed to help.
Diabetic macular oedema is a
condition that affects some people
with diabetes, and causes damage to
the light-sensitive layer at the back of
the eye responsible for central vision,
the macula. The active ingredient
helps to reduce the inflammation and
the swelling that builds up in
the
macula in this condition. Iluvien can
therefore help to improve the
damaged vision or stop it from
getting worse.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT RECEIVE _
_IT _
YOU MUST NOT

Summary of Product characteristics

20190729_ILU_PI_AU_Cat 1- Approved
1
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 https://www.tga.gov.au/reporting-problems.
AUSTRALIAN PI – ILUVIEN (FLUOCINOLONE ACETONIDE)
INTRAVITREAL IMPLANT IN APPLICATOR
1
NAME OF THE MEDICINE
ILUVIEN _fluocinolone acetonide_ 190 micrograms intravitreal implant
in applicator.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ILUVIEN
®
is a non-biodegradable intravitreal implant in a drug delivery system
containing 0.19
mg fluocinolone acetonide, designed to release fluocinolone acetonide
for 36 months.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
ILUVIEN is a sterile non-bioerodable intravitreal implant which is
inside a single use applicator
with a 25 gauge needle. The implant is a light brown colour and
cylindrical in shape with
dimensions 3.5 mm long x 0.37 mm in diameter. The applicator is
packaged in a plastic tray
sealed with a lid.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ILUVIEN is indicated for the treatment of diabetic macular oedema
(DME) in patients who have
been previously treated with a course of corticosteroids and did not
have a clinically significant
rise in intraocular pressure (IOP).
4.2
D
OSE AND METHOD OF ADMINISTRATION
For ophthalmic intravitreal injection.
The recommended dose is one ILUVIEN implant in the affected eye.
Administration in both eyes
concurrently has not been studied and is not recommended (see Section
4.4 Special warnings
and precautions for use).
▼
20190729_ILU_PI_AU_Cat 1- Approved
2
An additional implant may be administered after 12 months if the
patient experiences
decreased vision or an increase in retinal thickness secondary to
recurrent or worsening
diabetic macular oedema (see Section 5.1 Pharmacodynamic properties).
Retreatments should not be administered unless the potential benefits
outweigh the risks.
_Pae