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ILUVIEN 190 MICROGRAMS INTRAVITREAL IMPLANT IN APPLICATOR

Active substance(s): FLUOCINOLONE ACETONIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ILUVIEN 190 micrograms intravitreal implant in applicator
(fluocinolone acetonide)

Read all of this leaflet carefully before you are given this medicine because it contains
important information for you.

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Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor.
If you get any side effects, talk to your doctor. This includes any possible side effects not
listed in this leaflet. See section 4.

What is in this leaflet
1. What ILUVIEN is and what it is used for
2. What you need to know before you are given ILUVIEN
3. How ILUVIEN is administered
4. Possible side effects
5. How to store ILUVIEN
6. Contents of the pack and other information
1.
WHAT ILUVIEN IS AND WHAT IT 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 (the drug fluocinolone
acetonide) 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.
2.

WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ILUVIEN

You must not receive ILUVIEN:
- If you are allergic (hypersensitive) to fluocinolone acetonide or any of the other
ingredients of this medicine (listed in section 6).
- If you have an infection of any kind in or around your eye.
- If you have glaucoma (high pressure inside your eye).
Warnings and precautions

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Before your ILUVIEN injection tell your doctor if:
• You are taking any medicines to thin the blood
• You have had a herpes simplex infection in your eye in the past (an ulcer on the
eye that has been there a long time).

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ILUVIEN is given as an injection into the eye. Occasionally the injection may cause an
infection inside the eye, pain or redness in the eye, or a detachment or tear of the retina.
It is important to identify and treat these as soon as possible. Please tell your doctor
immediately if you develop increased eye pain or discomfort, worsening redness of your
eye, flashing lights and sudden increase in floaters, partially blocked vision, decreased
vision or increased sensitivity to light after your injection.
In some patients the eye pressure may increase with the possible development of
glaucoma. This is something you may not notice; therefore you must be monitored by
your doctor with visits to the clinic.
In the majority of patients who have not yet had an operation for cataracts, a clouding of
the eye’s natural lens (a cataract) may occur after treatment with ILUVIEN. If this occurs
your vision will decrease, and you are likely to need an operation to remove the cataract.
Your doctor will help you to decide when is the most appropriate time to perform this
operation, but you should be aware that until you are ready for your operation your vision
may be as bad or worse than it was before you received your ILUVIEN injection.
The injection of ILUVIEN into both eyes at the same time has not been studied and is not
recommended. Your doctor should not inject ILUVIEN into both eyes at the same time.
There is a potential for the ILUVIEN implant to move from the back to the front of the
eye. There is an increased risk of this if you have had previous cataract surgery. A sign
that the implant may have moved to the front of the eye could be distorted vision or other
visual disturbance, or you may notice a change in the appearance of your eye at the front.
Please tell your doctor if you notice anything unusual that may lead you to suspect the
implant has moved.

Children and adolescents (below 18 years of age)
The use of ILUVIEN in children and adolescents has not been studied and is therefore not
recommended.
Other medicines and ILUVIEN
Please tell your doctor if you are using or have recently used any other medicines, including
medicines bought without a prescription.
Pregnancy, breast-feeding and fertility

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There is no experience of using ILUVIEN in pregnant women or during breast-feeding;
therefore the potential risks are unknown.

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There are no fertility data available. However, since ILUVIEN is inserted directly into the
eye, effects on either male or female fertility is unlikely.

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If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor for advice before ILUVIEN treatment.

Driving and using machines
After ILUVIEN treatment you may experience some temporary vision blurring. If this
happens, do not drive or use machines until this resolves.

3.

HOW ILUVIEN IS ADMINISTERED

The ILUVIEN injection will be administered by your eye doctor.
ILUVIEN is given as a single injection into your eye. Afterwards, your doctor will monitor
your vision regularly.
Before the injection, your doctor will use antibiotic eye drops and wash your eye carefully to
prevent infection. Your doctor will also give you a local anaesthetic to prevent any pain that
the injection might cause.
Before and after the injection, your doctor may ask you to use antibiotic eye drops in order to
prevent any possible eye infection. Please follow these instructions carefully.
If the effect of the implant wears off and your doctor recommends it, another implant may be
injected into your eye.
If you have any further questions on the use of this medicine, ask your doctor.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, ILUVIEN can cause side effects, although not everybody gets them.
With administration of ILUVIEN, there may be some side effects, mostly in the eye.
Occasionally the injection may cause an infection inside the eye, pain or redness in the eye, or
a detachment or tear of the retina. It is important to identify and treat these as soon as
possible. Please tell your doctor immediately if you develop increased eye pain or
discomfort, worsening redness of your eye, flashing lights and sudden increase in floaters,
partial blocked vision, decreased vision or increased sensitivity to light after your injection.
Other side effects may include increased eye pressure or clouding of the eye’s natural lens.
Increased pressure in the eye which damages the optic nerve (glaucoma) may be more likely
if the pressure inside your eye is higher than average before treatment. Your doctor will
discuss the risks of this with you before treatment. The symptoms you might experience and
what you should do if you experience these symptoms are described in Section 2 of this
leaflet (Warnings and precautions).
The following side effects have been observed in clinical studies done with ILUVIEN:
Very common (affects more than 1 in 10 patients)

Increased eye pressure, clouding of the eye’s natural lens (cataract) or eye surgery to
correct the cataract.
Common (affects between 1 and 10 in every 100 patients)
Bleeding in the white part of your eye or inside the eye, small particles or spots in vision
(floaters), increased pressure in the eye which damages the optic nerve (glaucoma), eye pain
or irritation, reduced vision, or eye surgery or procedure to relieve increased eye pressure or
to remove the gel material that fills the back of the eye.

Uncommon (affects fewer than 1 in every 100 patients)
Blockage of the blood vessels at the back of the eye, new blood vessel growth inside the eye,
ulcer on the white of the eye, changes in the gel material that fills the back of the eye,
clouding of the bag holding the lens of the eye, redness of the eye, itching or infection of the
eye, thinning of the white outer layer of the eye, trauma to the eye from the injection of the
medicine, unplanned movement of implant through white part of eye, and/or other
complications from the injection, movement of the ILUVIEN implant from the back to the
front of the eye.
The most common non-visual side effect reported to be possibly caused by the drug or by the
injection procedure is headache.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly via the national reporting system.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
By reporting side effects you can help provide more information on the safety of this
medicine.
5.

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6.

HOW TO STORE ILUVIEN
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and inner wrap
after EXP.
Store below 30°C.
Do not refrigerate or freeze.
Do not open the sealed tray until just before application.

CONTENTS OF THE PACK AND OTHER INFORMATION

What ILUVIEN contains

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The active substance is fluocinolone acetonide.
Each intravitreal implant contains 190 micrograms fluocinolone acetonide.
The other ingredient is polyvinyl alcohol.
The implant is a tiny tube made of polyimide and sealed with silicone adhesive on
one end and polyvinyl alcohol on the other end.

What ILUVIEN looks like and contents of the pack
ILUVIEN consists of a tiny light brown tube (approximately 3.5 mm x 0.37 mm) which is
preloaded in an applicator system. The preloaded applicator is placed in a polycarbonate tray
and sealed with a peelable lid. Each sealed tray is provided in a carton which includes the
package leaflet.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Alimera Sciences Limited
Royal Pavilion
Wellesley Road
Aldershot
Hampshire
GU11 1PZ
United Kingdom
UK Tel: 0800 019 1253
IE Tel: 1800 932 379
Manufacturer:
AndersonBrecon (UK) Limited
Wye Valley Business Park Hay-on-Wye
Hereford HR3 5PG, United Kingdom
This leaflet was last revised in 10/2015
This medicinal product is authorised in the following Member States of the EEA under
the invented name ‘Iluvien’:
Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy,
Luxembourg, The Netherlands, Norway, Poland, Portugal, Spain, Sweden, United Kingdom.
<-------------------------------------------------------------------------------------------------------------->
The following information is intended for healthcare professionals only:

THERAPEUTIC INDICATIONS
ILUVIEN is indicated for the treatment of vision impairment associated with chronic diabetic
macular oedema, considered insufficiently responsive to available therapies.
CONTRAINDICATIONS
An intravitreal implant with ILUVIEN is contraindicated in the presence of pre-existing
glaucoma or active or suspected ocular or periocular infection including most viral diseases of
the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic
keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
ILUVIEN is contraindicated in patients with a hypersensitivity to the active substance or to
any of the excipients.
METHOD OF ADMINISTRATION

FOR INTRAVITREAL USE ONLY.
Treatment with ILUVIEN is for intravitreal use only and should be administered by an
ophthalmologist experienced in intravitreal injections. The intravitreal injection procedure
should be carried out under controlled aseptic conditions, which include use of sterile gloves,
a sterile drape, and a sterile eyelid speculum (or equivalent). Adequate anaesthesia and a
broad-spectrum microbicide should be given prior to the injection.
The injection procedure for ILUVIEN is as follows:
1. Preoperative antibiotic drops may be administered at the discretion of the treating
ophthalmologist.
2. Just prior to injection, administer topical anaesthesia over the injection site
(inferotemporal quadrant recommended) as one drop followed by either a cottontipped applicator soaked in anaesthetic or as subconjunctival administration of
adequate anaesthesia.
3. Administer 2-3 drops of adequate topical antiseptic into the lower fornix. The lids
may be scrubbed with cotton-tipped applicators soaked with an adequate topical
antiseptic. Place a sterile lid speculum. Have the subject look up and apply a cottontipped applicator soaked with an adequate antiseptic to the injection site. Allow 30-60
seconds for the topical antiseptic to dry prior to injection of ILUVIEN.
4. The exterior of the tray should not be considered sterile. An assistant (non-sterile)
should remove the tray from the carton and examine the tray and lid for damage. If
damaged, do not use unit.
If acceptable, the assistant should peel the lid from the tray without touching the
interior surface.
5. Visually check through the viewing window of the preloaded applicator to ensure that
there is a drug implant inside.
6. Remove the applicator from the tray with sterile gloved hands touching only the
sterile surface and applicator.
The protective cap on the needle should not be removed until ILUVIEN is to be
injected.
Prior to injection, the applicator tip must be kept above the horizontal plane to ensure
that the implant is properly positioned within the applicator.
7. To reduce the amount of air administered with the implant, the administration
procedure requires two steps. Before injecting the needle in the eye, push the button
down and slide it to the first stop (at the curved black marks alongside the button
track). At the first stop, release the button and it will move to the UP position. If the
button does not rise to the UP position, do not proceed with this unit.
8. Optimal placement of the implant is inferior to the optic disc and posterior to the
equator of the eye. Measure 4 millimeters inferotemporal from the limbus with the
aid of calipers.
9. Carefully remove the protective cap from the needle and inspect the tip to ensure it is
not bent.

10. Gently displace the conjunctiva so that after withdrawing the needle, the conjunctival
and scleral needle entry sites will not align. Care should be taken to avoid contact
between the needle and the lid margin or lashes. Insert the needle in the eye. To
release the implant, while the button is in the UP position, advance the button by
sliding it forward to the end of the button track and remove the needle. Note: Ensure
that the button reaches the end of the track before removing the needle.
11. Remove the lid speculum and perform indirect ophthalmoscopy to verify placement
of the implant, adequate central retinal artery perfusion and absence of any other
complications. Scleral depression may enhance visualisation of the implant.
Examination should include a check for perfusion of the optic nerve head
immediately after the injection. Immediate IOP measurement may be performed at
the discretion of the ophthalmologist.
Following the procedure, patients should be monitored for potential complications such as
endophthalmitis, increased intraocular pressure, retinal detachments, and vitreous
haemorrhages or detachments. Biomicroscopy with tonometry should be performed between
two and seven days after the implant insertion.
Thereafter it is recommended that patients are monitored at least quarterly for potential
complications, due to the extended duration of release of fluocinolone acetonide, of
approximately 36 months.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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